[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-of-prostate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-of-prostate":143},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,73,99,123,163,187,210,230,256,278],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100467057","phase-2-a-phase-ii-study-evaluating-t-cell-clonality-after-stereotactic-body-radiation-therapy-alone-and-in-combination-with-the-immunocytokine-pds01adc-in-localized-high-and-intermediate-risk-prostate-cancer-treated-with-androgen-deprivation-therapy-100467057",false,"NCT05361798","A Phase II Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine PDS01ADC in Localized High and Intermediate Risk Prostate Cancer Treated With Androgen Deprivation Therapy","* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed localized intermediate or high risk prostate cancer:\n\n  * Intermediate risk - Gleason 7 disease, PSA less than 10\n  * High Risk - Gleason 8-10, PSA\\>10, Extracapsular Extension\n* Participants must require treatment with SBRT to the prostate and ADT.\n* Pre-treatment tissue availability (collected \\\u003C= 1 year to initiation of study therapy) for biomarker analysis is mandatory for enrollment. If tissue is determined to be of insufficient\u002Funsuitable quality\u002Fquantity, a pre-treatment biopsy prior to initiation of study therapy will be required.\n* Male age \\>= 18 years old\n* ECOG performance status \\\u003C 2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * absolute neutrophil count \\>= 1,500\u002FmcL, without CSF support\n  * platelets \\>= 100,000\u002FmcL\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C= 2.5 X institutional upper limit of normal\n  * Hgb \\>= 10g\u002FdL (pRBC transfusions are not allowed to achieve acceptable Hgb)\n  * Total bilirubin \\\u003C= 1.5 x upper limit of normal (ULN),\n\nOR\n\nin participants with Gilbert s syndrome, a total bilirubin \\\u003C= 3.0\n\n* Serum albumin \\>= 2.8 g\u002FdL\n* Creatine \\\u003C= 1.5 X institutional ULN\n\nOR\n\n* Creatinine clearance \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal by 24h urine\n* PT\u002FINR and aPTT \\\u003C= 1.5 X institutional ULN\n\n  * Testosterone greater than 100 ng\u002FdL.\n  * Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) after study entry and for 6 months after completion of radiation treatment or immunotherapy (if taken, whatever is last)\n  * Participants must have prostate cancer accessible for biopsy\n  * Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Evidence of distant metastatic disease (including clinically or pathologically positive lymph nodes or metastatic disease outside of the pelvis).\n* Previous prostatectomy, focal therapy, or radiation to the prostate. Note: Previous finasteride, dutasteride, bicalutamide are allowed at PI discretion.\n* Initiation of ADT or SBRT or pelvic nodal radiation irradiation prior to trial enrollment (no time limit).\n* Live vaccine therapies for the prevention of infectious disease within 30 days prior to treatment administration. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted.\n* Contraindication to mpMRI including allergy or sensitivity to contrast agents (which cannot be alleviated by premedication)\n* Contraindications for SBRT such as: rectal wall invasion, history of inflammatory bowel disease, prior radiation in the treatment field that would exceed tissue tolerance.\n* Medical comorbidities that preclude the administration of androgen deprivation therapy or uncontrolled chronic or acute intercurrent illness \u002Fsocial situations or other illnesses considered by the Investigator as high risk for investigational drug treatment\n* Participants with active immune deficiencies, chronic inflammatory conditions, active autoimmune diseases, or participants on chronic immunosuppressive therapy for whom the primary endpoint of immune response could be impacted.\n* Participants requiring requiring systemic corticosteroids (\\>10 mg daily prednisone equivalent) or immunosuppressive medications except inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or dose not threaten vital organ function including CN, heart, lungs, kidneys, skin and GI track will be allowed\n* Participants with HIV\n* Active Hepatitis B or Hepatitis C infection\n* Significant acute or chronic infections including tuberculosis (history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings)\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to PDS01ADC.\n* Participants with prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast or low risk Gleason 6 prostate cancer.","MALE","18 Years",{"count":18,"type":19},65,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","Background:\n\nProstate cancer is often treated with radiation and ADT (ADT is androgen deprivation therapy). Up to 30% of these cancers recur within 5 years of treatment. Researchers want to see if a new drug (PDS01ADC) can help the immune system to fight prostate cancer.\n\nObjective:\n\nTo find what doses of PDS01ADC are safe in people who are treated for prostate cancer. Also, to see what effects PDS01ADC has on the immune system.\n\nEligibility:\n\nPeople aged 18 and older with high- and intermediate-risk prostate cancer. Their cancer must not have spread to other parts of the body.\n\nDesign:\n\nThe study will last 7 months.\n\nParticipants will be screened. They will share their medical history. They will also have:\n\n\\\u003CTAB\\>A physical exam\n\n\\\u003CTAB\\>Routine blood and urine tests\n\n\\\u003CTAB\\>Imaging scans of the chest, abdomen, and pelvis\n\n\\\u003CTAB\\>A bone scan\n\n\\\u003CTAB\\>A tumor biopsy\n\n\\\u003CTAB\\>A specialized MRI. Participants will lie face down on the MRI scanner table. An antenna that receives a signal may be placed in the rectum.\n\nAll participants will be treated with radiation therapy and ADT.\n\nSome participants will also receive PDS01ADC as an injection under the skin. This treatment will start 4 weeks after the radiation has ended. Participants will receive a total of 3 doses. The injections will be 4 weeks apart. Some screening tests will be repeated at each visit.\n\nParticipants who do not receive PDS01ADC will also have screening tests during the treatment period.\n\nParticipants will return for follow-up about 1 month after the last treatment or set of tests.",[25],"Cancer Of Prostate",[27,28,25,29],"Immunotherapy + Radiation","Combination Therapy","Nhs-Il 12","RECRUITING","2026-06-26",{"date":33,"type":34},"2026-06-29","ACTUAL",{"date":36,"type":34},"2023-06-12",{"date":38,"type":19},"2026-12-01",{"name":40,"class":41},"National Cancer Institute (NCI)","NIH",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":42},"100312974","profiling-of-radiological-factors-in-treatment-and-outcomes-in-prostate-cancer-100312974","NCT03354416","Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer","* INCLUSION CRITERIA:\n* Patients with an increased risk for prostate cancer (strong family history and\u002For germline mutation in DNA repair genes), or with a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions.\n* Age greater than or equal to 18 years\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n-none",{"count":50,"type":19},10000,"OBSERVATIONAL","Background:\n\nProstate cancer is one of the most common cancers for men in the U.S. There are some new ways to take pictures of the cancer. There are also new ways to use image-guided biopsy and therapy. These could help manage prostate cancer. Researchers want to study how imaging can provide a profile of prostate cancer. They want to collect data to make diagnosis and treatments better.\n\nObjectives:\n\nTo gather data about the radiological and clinical course of prostate cancer. To study imaging-based biomarkers of prostate cancer.\n\nEligibility:\n\nMen ages 18 and older with diagnosed or suspected prostate cancer\n\nDesign:\n\nParticipants will give permission for researchers to use their medical history and records. Their data will be reviewed, collected, and analyzed. These include results of their tests and scans.\n\nSponsoring Institution: National Cancer Institute",[54,55,56,57,25],"Prostatic Cancer","Prostatic Neoplams","Prostatic Hyperplasia","Prostate Cancer",[59,60,61,62,63,64],"Imaging-Based Prognostic Markers","Multiparametric MRI (mpMRI)","Translation of Imaging into Treatment Decisions","Decision-Support System","Artificial Intelligence Research","Natural History","2026-06-24",{"date":67,"type":34},"2026-06-25",{"date":69,"type":34},"2018-02-26",{"date":71,"type":19},"2033-12-31",{"name":40,"class":41},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":20,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":42},"100411110","phase-1-a-phase-iii-study-of-pds01adc-with-docetaxel-and-abiraterone-in-adults-with-metastatic-castration-sensitive-and-pds01adc-with-docetaxel-in-castration-resistant-prostate-cancer-100411110","NCT04633252","A Phase I\u002FII Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer","* INCLUSION CRITERIA:\n* Participants must have documented histopathological confirmation of prostate cancer. If no pathologic specimen is available, participants may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.\n* Participants must have metastatic disease, defined as at least one lesion on TC99 bone scan or at least one lesion that is measurable per, per RECIST 1.1.\n* mCSPC participants:\n* Participants must be within 134 days of starting ADT.\n* If participants are on ADT and responding, this may impact the findings on scans. Pre- treatment scans could be used to confirm that participants have metastatic high-volume disease in such cases.\n\n  * For Cohorts 1 and 2, Dose escalation and Safety Run-in, only: mCSPC may have high or low volume disease.\n  * For Cohort 3, Dose Expansion: mCSPC participants must have high volume disease (as defined by visceral lesion or 4 or greater bone lesions, at least one of which is beyond the spine and pelvis).\n* mCRPC participants:\n* Must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Must have not had progression while on docetaxel if given for mCSPC or within 3 months of completing docetaxel for mCSPC.\n* Progression defined as either rising PSA greater than 2.0 ng\u002Fml or radiographic evidence of progression seen on CT scan or TC-99 bone scan.\n* Toxicities related to prior therapy, including surgery and\u002F or radiation, must have resolved to \\\u003C= grade 1.\n* Men age \\>=18 years. Because no dosing or adverse event data are currently available on the use ofINCLUSION CRITERIA:\n* Participants must have documented histopathological confirmation of prostate cancer. If no pathologic specimen is available, participants may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.\n* Participants must have metastatic disease, defined as at least one lesion on TC99 bone scan or at least one lesion that is measurable per, per RECIST 1.1.\n* mCSPC participants:\n* Participants must be within 134 days of starting ADT.\n* If participants are on ADT and responding, this may impact the findings on scans. Pre- treatment scans could be used to confirm that participants have metastatic high-volume disease in such cases.\n\n  * For Cohorts 1 and 2, Dose escalation and Safety Run-in, only: mCSPC may have high or low volume disease.\n  * For Cohort 3, Dose Expansion: mCSPC participants must have high volume disease (as defined by visceral lesion or 4 or greater bone lesions, at least one of which is beyond the spine and pelvis).\n* mCRPC participants:\n* Must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Must have not had progression while on docetaxel if given for mCSPC or within 3 months of completing docetaxel for mCSPC.\n* Progression defined as either rising PSA greater than 2.0 ng\u002Fml or radiographic evidence of progression seen on CT scan or TC-99 bone scan.\n* Toxicities related to prior therapy, including surgery and\u002F or radiation, must have resolved to \\\u003C= grade 1.\n* Men age \\>=18 years. Because no dosing or adverse event data are currently available on the use of PDS01ADC in combination with docetaxel in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status 0-2.\n* Participants must have adequate organ and marrow function as defined below:\n* Absolute neutrophil count \\>=1,500\u002FmcL, without CSF support\n* Platelets \\>=100,000\u002FmcL\n* Hemoglobin \\>9 g\u002FdL\n* PT \\\u003C= 1.5 x ULN\n* aPTT \\\u003C= 1.5 x ULN\n* Total bilirubin \\\u003C= upper limit of normal (ULN), OR in participants with Gilbert's syndrome, a total bilirubin \\\u003C= 3.0\n* Serum albumin \\>=2.8 g\u002FdL\n* AST(SGOT)\u002FALT(SGPT) \\\u003C=1.5 X institutional upper limit of normal\n\n  \\-- Hepatic function based on Child-Pugh Class: Participants with hepatic impairment must have Child-Pugh Class A or better\n* Serum Creatinine OR Creatinine Clearance \\\u003C= 1.5 X institutional upper limits of normal OR \\>=50 mL\u002Fmin\u002F1.73 m\\^2 calculated by eGFR in the clinical lab for participants with serum creatinine levels \\> 1.5 ULN\n* The effects of PDS01ADC in combination with docetaxel and abiraterone on the developing human fetus are unknown. For this reason and because docetaxel agents as well as other immuno-therapeutic agents used in this trial are known to be teratogenic, sexually active subjects and their female partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom)after enrollment on study , during the study treatment and for 4 months after the last dose of abiraterone, docetaxel or PDS01ADC, even if oral contraceptives are also used. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately and her partner should inform the study doctor immediately.\n* Ability of subject to understand and the willingness to sign a written informed consent document. Subject should be willing to travel to the NIH for follow-up visits.\n* Participants with prior immune checkpoint therapy are eligible to enroll upon PI discretion.\n\nEXCLUSION CRITERIA:\n\n* Immunocompromised status due to:\n\n  * Human immunodeficiency virus (HIV) positivity\n  * Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be allowed.\n  * Other immunodeficiency diseases that in the opinion of the investigator could compromise the participant or limit treatment efficacy\n* Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with participant s ability to carry out the treatment program.\n* Current use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto).\n* Concurrent use of CYP3A4 inducers or sensitive CYP2D6 substrates within 14 days or 5 half-lives, whichever is shorter.\n* Receipt of any investigational agent within 28 days (or 60 days for an antibody drug conjugates) before the first planned dose of study drugs.\n* Participants who are positive for Hepatitis B surface antigen and\u002For Anti-Hepatitis C antibody\n* Uncontrolled hypertension (SBP\\>170\u002F DBP\\>105)\n* Has received or will receive a live vaccine within 30 days prior to the first administration of study intervention. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted.\n* Participants who have had prior docetaxel for mCRPC\n* mCSPC participants will be excluded if they did not start abiraterone within 6 weeks of ADT and\u002For had any docetaxel\n* Participants who have had progression within 3 months of completing docetaxel for mCSPC\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to PDS01ADC investigational agents used in the study\n* The subject has had evidence within 3 years of the start of study treatment of another active malignancy which required systemic treatment (except for nonmelanoma skin cancers or carcinoma in situ of the bladder).\n* The subject has active brain metastases or epidural disease.\n* Participants with greater than or equal to grade 2 peripheral neuropathy (defined by CTCAE 5.0) at baseline.","110 Years",{"count":81,"type":19},86,[83,22],"PHASE1","Background:\n\nMetastatic castration sensitive and castration resistant prostate cancer (mCSPC and mCRPC) are prostate cancers that have spread to other parts of the body. Use of the drug docetaxel with androgen deprivation therapy can improve survival for men with mCSPC. Researchers want to see if combining this treatment with other drugs can help delay the time it takes for mCSPC and mCRPC to get worse.\n\nObjective:\n\nTo learn if giving docetaxel with PDS01ADC is safe and effective for men with prostate cancer.\n\nEligibility:\n\nMen age 18 and older with mCSPC or mCRPC.\n\nDesign:\n\nParticipants will be screened with a medical history and physical exam. Their diagnosis will be confirmed. Their symptoms and how well they do their normal activities will be reviewed. They will have blood and urine tests. Their heart will be evaluated. They will have imaging scans of the chest, abdomen, and pelvis. They will have bone scans with intravenous (IV) injections of Tc99 to check for tumor spread in the bones.\n\nSome screening tests will be repeated during the study.\n\nParticipants may have tumor biopsies.\n\nParticipants will get treatment in cycles. Each cycle will last 21 days. They will get docetaxel through IV infusion. They will get PDS01ADC as an injection under the skin.\n\nParticipants with mCSPC will have up to 6 cycles. Those with mCRPC will be treated until they cannot tolerate the side effects or their disease gets worse.\n\nParticipants will have a follow-up visit 30 days after treatment ends. Those with mCSPC will then have follow-up visits at the clinic every 3 months.",[25,86],"Prostate Neoplasms",[88,89,90,28],"Chemoimmunotherapy","NHS IL-12","Check point inhibitor","2026-06-13",{"date":93,"type":34},"2026-06-16",{"date":95,"type":34},"2021-02-23",{"date":97,"type":19},"2026-12-31",{"name":40,"class":41},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":4,"leadSponsor":122,"locationsCount":42},"100127142","collection-of-blood-from-patients-with-prostate-cancer-100127142","NCT00923221","Collection of Blood From Patients With Prostate Cancer","* INCLUSION CRITERIA:\n\nIndividuals 18 years of age and older are eligible.\n\nIndividuals with a diagnosis of prostate cancer are eligible.\n\nEXCLUSION CRITERIA:\n\nChildren are not eligible.",{"count":106,"type":19},1000,"Background:\n\n* It is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role.\n* Genes contain the hereditary information that is passed down from parents to children. Although everyone has the same set of genes, individuals can have different forms of the same gene.\n* Differences in genes may explain, at least in part, why some people develop a more aggressive form of prostate cancer than others.\n\nObjectives:\n\n-To obtain blood samples from patients with prostate cancer to try to identify gene differences associated with progression to the androgen independent state.\n\nEligibility:\n\n-All participants participating in NCI prostate cancer protocols.\n\nDesign:\n\n* Participants with prostate cancer are evaluated in the NCI s Medical Oncology Clinic.\n* Blood samples are collected at the initial visit or at follow-up visits.\n* DNA (genetic material) and white blood cells are extracted from these samples to be used for genotyping and establishment of cell lines.\n* Gene variations are correlated with prostate cancer prognosis and prognostic indicators.",[25,57,109,110,111],"Prostatic Neoplasms","Metastatic Prostate Cancer","Prostate",[113,109,114,115,116,64,57],"Genetic","Genotyping","Venipuncture","Polymorphism","2026-06-05",{"date":119,"type":34},"2026-06-08",{"date":121,"type":34},"2007-02-28",{"name":40,"class":41},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":130,"minAge":16,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":20,"phases":134,"briefSummary":135,"conditions":136,"keywords":148,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":162},"100598533","phase-2-psilocybin-assisted-psychotherapy-in-cancer-patients-with-adjustment-disorder-100598533","NCT07072728","Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder","A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.","Inclusion Criteria:\n\nTo be eligible for study entry participants must satisfy all of the following criteria:\n\n1. Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of ≥ 4 on the Distress Thermometer.\n2. Screening HAM-A Score ≥18 (moderate anxiety).\n3. Adults aged 18 to 80 years (inclusive) at screening.\n4. Diagnosed with cancer (exempting those cancers listed in the exclusion criteria) and a minimum life-expectancy of 6 months in the opinion of the treating physician, with performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale performed at screening.\n5. Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10.\n6. Able to communicate well and follow study procedures, judged as sufficiently competent with the English language by the investigator, able to build adequate rapport with study staff.\n7. Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and the opinion of a research team psychiatrist.\n8. Be medically suitable in the opinion of the investigator as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and blood tests.\n9. Have access to a device that is compatible to use the digital technology, i.e smart-phone device or tablet.\n10. Agree not to take any sedating medications for a minimum of 12 hours before the dosing session including benzodiazepines, zopiclone, eszopiclone, zaleplon and zolpidem. Medications for cancer-related pain are permitted.\n11. Must be willing and able to refrain from smoking throughout the duration of the dosing session. Nicotine replacement therapies may be permitted with the agreement of the medical monitor.\n12. Agree that for 1 week before the psilocybin dosing session, participants will refrain from taking any illegal drugs or non-prescription medication (including cannabis, or CBD or THC containing products), nutritional supplement, or herbal supplement except when approved by the study investigators. Additionally, agree not to take any form of psilocybin outside of the study, including microdosing, from baseline through Day 70\u002FWeek 10 (Visit 11).\n13. Participants taking any other medication that is not explicitly detailed as an excluded medication will be discussed with the investigator and medical monitor as appropriate. Decisions on inclusion will be based on clinical judgement and with sufficient justification provided.\n\nExclusion Criteria\n\nParticipants will be excluded from the study if one or more of the following criteria are applicable:\n\nPsychiatric Exclusion Criteria:\n\n1. Current Major Depressive Disorder MDD (or within 12 months of Screening) deemed independent from the cancer diagnosis, current or past diagnosis of schizophrenia, psychotic disorder, unless this was resulting from a medical condition (e.g. lupus or malaria etc.), bipolar disorder I and II, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anti-social personality disorder or judged to be incompatible with establishment of rapport or safe exposure to psilocybin, as determined using clinical judgement of past and present medical and psychiatric history by any specialist psychiatrist or registered medical professional under the authorized delegation of a specialist psychiatrist.\n2. First-degree relative with a diagnosed psychotic disorder.\n3. Scores from the screening psychiatrist (or registered medical professional under the authorized delegation of a specialist psychiatrist) and baseline (S-STS) that indicate that the participant is of clinically significant risk of suicide. A decision will be formed based on S-STS scores and used in combination with other clinically significant data at screening. Sites should refer to the medical monitor if required.\n4. Has attempted suicide in the twelve months preceding the screening visit.\n5. Current (\\\u003C 1 year) alcohol or drug misuse as identified as moderate or severe during screening in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, using the MINI 7.0.2, not able or willing to abstain from alcohol consumption in the period 12 hours prior to the dosing session.\n6. Any other reason that might prevent a participant from engaging in therapeutic preparation and integration sessions.\n7. Anyone who has taken a microdose of psilocybin within 5 days of baseline, taken a higher dose of psilocybin (e.g., dried mushrooms or capsules) within 30 days of baseline and experienced euphoria, hallucinations, or altered mental status, or used any classic psychedelics (LSD, ibogaine, ayahuasca, DMT, mescaline) within 3 months prior to baseline.\n\nMedical Exclusion Criteria:\n\n1. Diagnosed with brain metastases, glioblastoma, phaeochromocytoma, bowel obstruction or intestinal failure, active carcinoid syndrome, uncontrolled hypercalcaemia, or uncontrolled diabetes mellitus or insipidus.\n2. Currently taking or planning to take any of the following: any typical or atypical antipsychotic and monoamine-oxidase inhibitors. Participants with prior use of these medications must be willing to discontinue their use for at least 2 weeks prior to the baseline visit and to Day 28.\n3. Currently taking or planning to take any anticonvulsant or mood stabilizer, including carbamazepine, lithium, phenytoin, and valproate. Participants with prior use of these medications must be willing to discontinue their use for at least 1 week prior to the baseline visit and to Day 28.\n4. Any form of fungal allergy.\n5. Positive pregnancy test at screening, women who are breastfeeding or of childbearing potential who are unwilling or unable to use an effective form of contraception (or abstinence) for the study period and for 1 month post NPX-5 dose will be excluded. Women will be required to conduct a serum pregnancy test at the in-person screening visit and urine test prior to dosing session. Male participants who do not agree to use contraception for the study period and for 90 days post NPX-5 dose to mitigate the risk of pregnancy will also be excluded. Note: Refer to Section 4.3.2.1 for further details about contraception.\n6. A diagnosis of epilepsy or at significant risk of seizures based on medical history.\n7. Cardiovascular conditions including stroke and\u002For myocardial infarction (less than one year before providing informed consent), uncontrolled hypertension (blood pressure \\> 140\u002F90 mmHg) or clinically significant arrhythmia at screening. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.\n8. Anyone who, at screening, has clinically significant findings on physical examination, including resting vital signs (HR below 40 or above 120 bpm, blood pressure below 90\u002F60 or above 140\u002F90), ECG (QTcF \\> 450 msec for males and \\>470 for females), and positive alcohol breath test. Note: Inclusion of individuals with any out-of-range values, including blood pressure, is at the discretion of the Investigator.\n9. Liver dysfunction at screening as defined by AST and\u002For ALT \\> 1.5 times the upper level of normal or upper reference range. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to the administration of psilocybin, following discretion of the investigator.\n10. Renal Function: estimated glomerular filtration rate \\\u003C60 mL\u002Fmin (calculated using Chronic Kidney Disease Epidemiology Collaboration) unless this is a direct result of the cancer diagnosis and does not present a risk to the administration of psilocybin, following the discretion of the investigator.\n11. Any clinically significant laboratory abnormality(s) that in the opinion of the investigator would present a risk to the administration of psilocybin.\n12. Any clinically significant renal, pulmonary, gastrointestinal, hepatic, or other illness that could affect the interpretation of results or be a potential health risk for the person if they were to be included in the study. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.\n13. Below 18 or above 32kg\u002Fm2 Body Mass Index (BMI) score at Screening.\n14. Anyone with organic brain injury or diagnosed with any cognitive impairment.\n15. Positive urine drug test for non-prescribed psychoactive substances at the dosing session visit. Positive urine drug test for psychoactive substances at the in-person screening should be referred to the medical monitor. Note: Testing may be repeated once at the discretion of the Investigator.\n16. Anyone on a research study of an investigational drug or who has been on a clinical trial within 3 months of enrolment.","ALL","80 Years",{"count":133,"type":19},87,[22],"This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.\n\nWho is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder.\n\nStudy details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day).\n\nAt Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5.\n\nIt is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.",[137,138,139,140,141,142,143,144,145,146,147],"Adjustment Disorder","Adjustment Disorder With Anxious Mood","Cancer","Cancer Cachexia","Cancer of Endometrium","Cancer of Kidney","Cancer of Prostate","Cancer of the Breast","Cancer of Stomach","Cancer Melanoma Skin","Cancer Pancreas",[139,137,149,150,151],"Existential Distress","Psilocybin","Psilocin","2026-03-01",{"date":154,"type":34},"2026-03-03",{"date":156,"type":34},"2025-10-01",{"date":158,"type":19},"2027-07-30",{"name":160,"class":161},"Psyence Australia Pty Ltd","INDUSTRY",3,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":20,"phases":173,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":42},"100547348","the-impact-of-physical-activity-versus-dietary-energy-restriction-on-tumour-and-muscle-protein-synthesis-in-prostate-cancer-patients-100547348","NCT06406803","The Impact of Physical Activity Versus Dietary Energy Restriction on Tumour and Muscle Protein Synthesis in Prostate Cancer Patients","The Impact of Physical Activity Versus Dietary Energy Restriction on Prostate Tumour and Muscle Tissue Protein Synthesis in Vivo in Prostate Cancer Patients","DIRECT","Inclusion Criteria:\n\n* Diagnosed with prostate cancer (Stages I-III)\n* Scheduled to undergo a prostatectomy\n* BMI between 18.5-35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Receiving pre-operative chemo, hormonal, radio therapy\n* Physically unable to perform the exercise program\n* Performing \\>300 min of moderate-vigorous physical activity per week (e.g., running, road cycling, swimming).",{"count":172,"type":19},45,[174],"NA","Background: Prostate cancer is the second most common cancer and the fifth leading cause of death in men worldwide. Tumour growth is attributed to disproportionately greater protein synthesis rates relative to protein breakdown rates. Tumour protein synthesis is modulated by several factors, including energy availability, blood flow, and hormone concentrations (e.g., IGF-1). Lifestyle modifications are rapidly becoming recognized as important adjunct therapeutic approaches to slow cancer development and enhance treatment efficacy. Dietary energy restriction is a 30-50% reduction in food intake, which induces an energy deficit and has been shown to attenuate tumour growth in rodent models. Muscle mass often declines during cancer treatment and negatively impacts treatment success rates and recovery. One drawback to dietary energy restriction is that it may accelerate declines in skeletal muscle mass and strength in cancer patients. Exercise also induces an energy deficit by increasing energy expenditure. In addition, exercise alters blood flow and releases circulating molecules, which appear to lower tumour protein synthesis rates. Exercise increases muscle protein synthesis rates, which would provide further benefits to cancer patients by helping to maintain skeletal muscle mass. Despite their promising therapeutic properties, the clinical efficacy of dietary energy restriction and exercise has not been directly determined in vivo in cancer patients.\n\nHypothesis and Objectives: The objective of this study is to compare the impact of dietary energy restriction versus (isocaloric) daily exercise on muscle, prostate, and prostate tumour protein synthesis rates over a 7-day period in vivo in prostate cancer patients.\n\nIt is hypothesized that 1) dietary energy restriction will lower both prostate tumour and muscle tissue protein synthesis rates and that 2) daily exercise will lower prostate tumour protein synthesis rates but increase muscle protein synthesis rates in prostate cancer patients.\n\nSetting and Methods: Forty-five prostate cancer patients scheduled to undergo radical prostatectomy will be randomly assigned to one of three groups. The first group will undergo 7 days of dietary energy restriction (40% less food intake). The second group will perform 7 days of daily exercise and mild dietary energy restriction resulting in a total energy deficit of 40%. The third group will follow their regular diet and physical activity (control group). The research team will provide all aspects of the intervention (standardized meals, personalized exercise supervision). Patients will ingest deuterium-labelled water (2H2O) throughout the intervention period. After 7 days, patients will undergo a radical prostatectomy, during which tumour tissue, skeletal muscle tissue, and blood will be collected. Deuterium (2H-alanine) incorporation into the tissue samples will be measured to assess prostate tumour and skeletal muscle tissue protein synthesis rates.",[143],"2026-01-15",{"date":179,"type":34},"2026-01-16",{"date":181,"type":34},"2024-10-12",{"date":183,"type":19},"2026-02",{"name":185,"class":186},"Maastricht University Medical Center","OTHER",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":20,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":42},"100485386","improving-sexual-quality-of-life---randomized-trial-of-two-vs-five-mri-guided-sabr-treatments-for-prostate-cancer-100485386","NCT05600400","Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer","Improving Sexual Quality of Life - A Phase 2 Randomized Controlled Trial of Two Versus Five Stereotactic MRI-Guided Ablative Radiotherapy Treatments for Prostate Cancer","iSMART","Inclusion Criteria:\n\n1. Histologically confirmed prostate adenocarcinoma (centrally reviewed)\n2. Low or favorable intermediate risk disease. Patient must meet one of the following categories:\n\n   * Low risk - T1-T2b, grade group 1, AND PSA \\\u003C 10 ng\u002Fml;\n   * Favorable risk\n\n     1. Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng\u002Fml; or\n     2. Grade group 3 AND PSA \\\u003C 20, AND \\\u003CcT2c AND absolute percentage pattern 4\u002F5 is \\\u003C10%\n\nExclusion Criteria:\n\n1. Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned\n2. Prior pelvic radiotherapy\n3. Anticoagulation medication (if unsafe to discontinue for gold seed insertion)\n4. Diagnosis of bleeding diathesis\n5. Large prostate (\\>90cm3) on imaging\n6. Immunosuppressive medications\n7. Inflammatory bowel disease\n8. Presence of dual hip prostheses\n9. Contraindications to having MRI",{"count":196,"type":19},144,[174],"Prostate Stereotactic ablative body radiotherapy (SABR) is an established technique that delivers radiation in a non-invasive approach for men with prostate cancer. The treatment regimen is given in total of 5 fractions with one treatment per day at every other day or weekly sessions. Ultra-hypofractionated radiotherapy (UHRT) is an emerging monotherapy for localized prostate cancer however, several trials have observed demonstrating superior biochemical control of a two-fraction (HDR) over single-fraction approach. The study aims to compare an experimental shorter course of prostate ultra-hypofractionated radiotherapy (UHRT) that will deliver what is expected to be an equivalent amount of radiation as given in the standard 5 treatment regimen. UHRT is given in 2 treatments with one treatment a week for 2 consecutive weeks.",[57,143,200],"Prostate Adenocarcinoma","2025-09-02",{"date":203,"type":34},"2025-09-09",{"date":205,"type":34},"2024-03-01",{"date":207,"type":19},"2029-06",{"name":209,"class":186},"Sunnybrook Health Sciences Centre",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":42},"100558704","investigation-of-three-biomarkers-for-the-detection-of-prostate-cancer-100558704","NCT06554587","Investigation of Three Biomarkers for the Detection of Prostate Cancer","Evaluation of the Performance of the Glycoscore Biomarkers for the Detection of Clinically Significant Prostate Cancer","Inclusion Criteria:\n\n* Male patients aged 18 years and over\n* The patient is being investigated for suspected prostate cancer or is on active surveillance\n* The patient is able to give consent to take part in the study\n\nExclusion Criteria:\n\n* A patient who has already taken part in the study\n* A patient with an active urinary tract infection\n* The patient has a prior diagnosis of any other cancer or is receiving any cancer treatment (including ADT)\n* The patient is currently or within the last 4 months enrolled on another study involving an investigational medicinal product",{"count":218,"type":19},137,"GlycoScore Dx Limited, a diagnostics company based in the United Kingdom have identified three glycoproteins, that showed promise as biomarkers of prostate cancer in initial validation studies. The purpose of this study is to further evaluate the sensitivity and specificity of the GlycoScore biomarkers for the detection of clinically significant prostate cancer. Sensitivity and specificity will be determined for each marker, combinations of the three markers and combinations of the GlycoScore biomarkers with PSA (prostate specific antigen). The results from this study will be used to identify the most suitable biomarker\u002Fbiomarkers for use in developing a GlycoScore test.\n\nThis is a prospective, non-interventional study using venous blood samples taken from patients with suspected prostate cancer or on active surveillance, attending the hospital Urology department for a transperineal biopsy.",[143],"2025-01-16",{"date":223,"type":34},"2025-01-17",{"date":225,"type":34},"2025-01-07",{"date":227,"type":19},"2026-03-07",{"name":229,"class":161},"Medtechtomarket Consulting Ltd",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":20,"phases":239,"briefSummary":240,"conditions":241,"keywords":243,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":254,"locationsCount":42},"100455774","a-intervention-for-reducing-sedentary-behaviour-among-prostate-cancer-survivors-100455774","NCT05214937","A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors","A Distance-based, Randomized Controlled Trial for Reducing Sedentary Behaviour Among Prostate Cancer Survivors","Inclusion Criteria:\n\n* \\>= 18 years of age\n* Diagnosed with localized or asymptomatic metastatic primary prostate cancer\n* Not currently undergoing radiation or chemotherapy\n* Proficient in English\n* Not physically active (self report \\\u003C150 minutes of moderate-to-vigorous physical activity per week)\n* Self-report \\>8 hours of daily sedentary behaviour\n* In the contemplation or preparation stage for motivational readiness to change as determined by the Stages of Change Questionnaire\n* Access to a smartphone, tablet, or computer\n* No cardiac contraindications (e.g., unstable angina, arrhythmia, heart failure, aortic stenosis)\n* Medical clearance from a primary health care provider (if necessary)\n* Currently residing in Canada\n\nExclusion Criteria:\n\n* Not planning to live in Canada for the next 12 months\n* A medical condition that prohibits walking (e.g., severe knee or hip arthritis)\n* Presence of other primary or recurrent invasive cancer (i.e., other than non-melanoma skin cancer)\n* Have had a prior fall within the last 12-months\n* Use a gait aid device",{"count":238,"type":19},120,[174],"This randomized controlled trial (RCT) will aim to examine the effect of a 12-week behavioural intervention on changing the sedentary behaviours (SB) of prostate cancer survivors (PCS) compared to a control group (FitBit-only group). PCS in the intervention group will receive a FitBit and 6 behavioural support sessions with a movement specialist guided by behavioural theory (i.e., the Multi-Process Action Control \\[M-PAC\\]). The FitBit-only group will only receive a FitBit and access to public health resources on physical activity (PA). The primary purpose of this study is to determine the efficacy of the intervention on changing SB of PCS immediately following the 12-week intervention and 6-months later. It is hypothesized that that the intervention will decrease their SB compared to the FitBit-only control condition at both timepoints. This trial will also examine the effect of the intervention on changing PA, motivational outcomes from the M-PAC framework, sleep quality, social support, physical function, quality of life, fatigue, disability and mental health compared to the active control condition.",[242,143],"Sedentary Behavior",[244,245,246,247],"distance-based","sedentary behavior","physical activity","cancer survivorship","2024-12-03",{"date":250,"type":34},"2024-12-04",{"date":252,"type":34},"2022-02-15",{"date":38,"type":19},{"name":255,"class":186},"University of Toronto",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":130,"minAge":16,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100489434","archery---artificial-intelligence-based-radiotherapy-treatment-planning-for-cervical-head-and-neck-and-prostate-cancer-100489434","NCT05653063","ARCHERY - Artificial Intelligence Based Radiotherapy Treatment Planning for Cervical, Head and Neck and Prostate Cancer","Inclusion Criteria:\n\n1. Consecutive patients with histologically confirmed head and neck cancers of the oropharynx, larynx, hypopharynx and nasopharynx (Stage I-III) that have given consent for radical radiotherapy.\n2. Consecutive histologically confirmed primary cervical cancer patients (Stage IB-IIIB including pelvic node positive) that have given consent for radical radiotherapy.\n3. Consecutive histologically confirmed primary prostate cancer patients (T1-4N0M0) that have given consent for radical radiotherapy.\n4. Mental capacity to understand and consent to participate in the study.\n5. Patients aged ≥18years.\n\nExclusion Criteria:\n\n1. Patients requiring radiotherapy after curative surgery or surgery that is intended to remove as much of the tumour as possible.\n2. Patients receiving palliative radiotherapy\n3. Patients aged \\\u003C 18years.",{"count":263,"type":19},990,"The aim of this study is to look at whether an Artificial Intelligence (AI) based computer program can automate two components of the radiotherapy treatment pathway to a sufficient quality standard to enable its routine clinical use. The two components include the delineation (outlining) of anatomical areas that are at risk of tumour spread and at risk of radiation damage, and the definition of the position, size and shape of the radiation beams.\n\nThe AI-based computer programs have been developed to perform tasks that would normally require direct human involvement by oncologists and medical physicists. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy, which this study will test.",[143,266,267],"Cancer Head Neck","Cancer Cervix","2024-05-20",{"date":270,"type":34},"2024-05-22",{"date":272,"type":34},"2023-12-07",{"date":274,"type":19},"2026-09-01",{"name":276,"class":186},"University College, London",6,{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":15,"minAge":286,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":20,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":309},"100540570","artificial-intelligence-3d-augmented-reality-robot-assisted-radical--prostatectomy-vs-no3d-intervention-100540570","NCT06318559","Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention","RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial","RIDERS","Inclusion Criteria:\n\n1. Signature of the written informed consent and consent to the use of personal data\n2. Age \\> 40 years and male sex\n3. Pre-operative MRI performed according to ESUR recommendations and reporting in accordance with PiRads V.2\n4. Disease with evidence of bulging or radiological T3 on pre-operative MRI\n5. Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI\n6. Absence of bulky (\\>3 cm), bony or visceral retroperitoneal or pelvic lymph node metastatic lesions\n7. Patients eligible for radical prostatectomy + pelvic lymphadenectomy\n8. ECOG PS 0-1\n9. Life expectancy ≥ 5 years\n10. Patients motivated to preserve erection and with pre-operative sexual activity with IIEF \\>17\n11. Availability of the patient's pre-operative clinical data\n12. Patients must be available to carry out the visits foreseen in the follow-up of the protocol and consent to data collection\n\nExclusion Criteria:\n\n1. Special histotypes of prostate cancer\n2. Patients with PSA \\> 100 ng\u002Fml at diagnosis\n3. Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction\n4. Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies\n5. Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections\n6. Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and\u002For signing informed consent.","40 Years","99 Years",{"count":238,"type":19},[174],"This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure.",[143],[293,143,294,295,296,297,298,299],"3D AI-AR-RARP","prostate surgery","Hyper-Accuracy 3D reconstruction (HA3DTM)","Riders","computer vision","Robot-assisted","laparoscopic radical prostatectomy","2024-03-15",{"date":302,"type":34},"2024-03-19",{"date":304,"type":34},"2022-06-29",{"date":306,"type":19},"2027-12-31",{"name":308,"class":186},"Fondazione del Piemonte per l'Oncologia",2]