[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biochemically-recurrent-prostate-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biochemically-recurrent-prostate-carcinoma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,67,94,117,141],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100578638","early-phase-1-an-investigational-scan-rhpsma-73-petct-for-detecting-biochemically-recurrent-prostate-cancer-enlighten-trial-100578638",false,"NCT06813898","An Investigational Scan (rhPSMA-7.3 PET\u002FCT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial","ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging","Inclusion Criteria:\n\n* Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary therapy \\[i.e. salvage radiation\\])\n* Men must have biochemical recurrence (defined as PSA \\>= 0.1ng\u002Fml) after therapy\n* PSA \\\u003C 0.5ng\u002Fml (within 90 days of enrollment)\n* Men must have had negative or equivocal PET PSMA based imaging with 90 days of enrollment with an Food and Drug Administration (FDA) approved non-POSLUMA tracer\n* Non-castrate testosterone (testosterone \\[T\\] \\> 50ng\u002FdL) within 90 days of study entry\n* Institutional Review Board (IRB)-\u002FIndependent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures\n* Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study\n* Concurrent diseases and malignancies are permitted\n\nExclusion Criteria:\n\n* Most recent PSA not between 0.1ng\u002Fml and 0.5ng\u002Fml\n* Men with non-metastatic castrate resistant prostate cancer (defined as rising PSA and T \\\u003C 50ng\u002Fdl)\n* Patients receiving 5-alpha reductase inhibitors, androgen deprivation therapy and androgen receptor antagonists within 3 months of enrollment (men may start these therapies at physician discretion immediately following POSLUMA PET PSMA scan)","MALE",{"count":18,"type":19},27,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","This phase II trial evaluates an imaging technique (rhPSMA-7.3 positron emission tomography \\[PET\\]\u002Fcomputed tomography \\[CT\\]) for detecting prostate cancer in patients who have increasing prostate-specific antigen levels following prior treatment (biochemical recurrence) but who were prostate specific membrane antigen negative on their most recent PET scan. Contrast agents like rhPSMA-7.3 (also called POSLUMA) circulate in the blood until they find their intended target. Once they are taken up by the target tumor cells, they can be visualized using PET\u002FCT cameras. A PET scan is a procedure in which a small amount of radioactive tracer (in this case rhPSMA-7.3) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET\u002FCT scans are hybrid scanners that combine both modalities into a single scan during the same examination. The researchers want to determine whether the rhPSMA7.3 PET\u002FCT scan is useful for detecting biochemically recurrent prostate cancer in patients who were negative on prior non-POSLUMA PET imaging.",[25,26],"Biochemically Recurrent Prostate Carcinoma","Prostate Adenocarcinoma","RECRUITING","2026-06-30",{"date":30,"type":31},"2026-07-02","ACTUAL",{"date":33,"type":31},"2025-04-11",{"date":35,"type":19},"2032-02-01",{"name":37,"class":38},"Northwestern University","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100394987","phase-3-treating-prostate-cancer-that-has-come-back-after-surgery-with-apalutamide-and-targeted-radiation-based-on-pet-imaging-100394987","NCT04423211","Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging","Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)","Inclusion Criteria:\n\n* STEP 0: REGISTRATION ELIGIBILITY CRITERIA\n* Patient must be male and \\>= 18 years of age.\n* Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma\n* Patient must have biochemical recurrence (BCR) after RP, defined as follows:\n\n  * If time to BCR, defined as time to first detectable PSA ( \\> lower limit of normal for assay used) after RP, is \\\u003C 12 months, a minimum PSA level of \\>= 0.2 ng\u002FmL and a confirmatory reading of \\>= 0.2 ng\u002FmL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng\u002FmL are eligible)\n  * If time to BCR, defined as time to first detectable PSA (\\> lower limit of normal for assay used) after RP, is \\>= 12 months, a minimum absolute PSA of 0.5 ng\u002FmL is required\n  * If the patient has a detectable PSA (\\> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum PSA requirement\n* Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen\u002Fpelvis or MRI abdomen\u002Fpelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET\u002FCT or PET\u002FMR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT\u002FMRI for soft tissue lesions and\u002For a bone scan for osseous lesions\n\n  * Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration\n* Extra-pelvic metastases is defined as any osseous metastases and\u002For any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields. Baseline PET\u002FCT or PET\u002FMR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration\n* Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET\u002FCT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT.\n* Patient must not be enrolled in another therapeutic clinical trial\n* Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery\n* Patients undergoing a PET\u002FMR must meet local institutional safety guidelines for MRI\n* Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration\n* Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy\n* Hemoglobin (Hgb) \\>= 9.0 g\u002FdL (independent of transfusion and\u002For growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)\n* Leukocytes \\>= 3,000\u002FmcL (obtained within 8 weeks prior to Step 0 registration)\n* Absolute neutrophil count \\>= 1,500\u002FmcL (obtained within 8 weeks prior to Step 0 registration)\n* Platelets \\>= 100,000\u002FmcL (obtained within 8 weeks prior to Step 0 registration)\n* Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome, if total bilirubin is \\> 1.5 x ULN, must have a direct bilirubin of \\\u003C 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration)\n* Creatine \\\u003C 1.5 x instituional ULN (or measured creatinine clearance \\> 30 mL\u002Fmin)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)\n* Patient must not have completed a course of prior pelvic radiation therapy for any reason\n* Patient must agree not to father children while on study\n* Patient must be English or Spanish speaking to be eligible for the QOL component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms\n* STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA\n* Patient must have completed a baseline SOC PET\u002FCT or PET\u002FMR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration\n* For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)\n* For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields \\[prostate bed +\u002F- typical whole pelvis\\]), the number of extra-pelvic lesions must be known (1 - 5 or \\> 5 extra-pelvic lesions)","18 Years",{"count":49,"type":19},804,[51],"PHASE3","This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen \\[PSA\\] after surgical removal of the prostate cancer).\n\nA second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested.\n\nDiagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.",[25,54,26,55],"Metastatic Prostate Carcinoma","Stage IVB Prostate Cancer AJCC v8","2026-06-16",{"date":58,"type":31},"2026-06-18",{"date":60,"type":31},"2020-10-08",{"date":62,"type":19},"2032-12-31",{"name":64,"class":65},"ECOG-ACRIN Cancer Research Group","NETWORK",342,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":20,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100545205","phase-2-stereotactic-body-radiation-therapy-plus-immediate-or-delayed-androgen-receptor-pathway-inhibitor-and-androgen-deprivation-therapy-or-salvage-radiation-therapy-for-the-treatment-of-prostate-cancer-divine-trial-100545205","NCT06378866","Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial","MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer","DIVINE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease characteristics:\n\n  * DEVIATE (Groups A and B only):\n\n    * Clinical confirmation of metachronous (metastatic) recurrent hormone-sensitive prostate cancer\n    * Five (5) or fewer metastases with at least one metastasis beyond the pelvis on advanced molecular and\u002For conventional imaging\n    * Serum testosterone \\> 100ng\u002FdL\n  * BRIO (Gropus C \\& D only):\n\n    * Prostate-specific antigen (PSA) between 0.2 and 1.5 ng\u002FmL with PSA above 0.2 on at least two consecutive measurements at least 5 days apart\n    * No local or metastatic recurrence apparent on advanced molecular imaging\n    * Serum testosterone \\> 100 ng\u002FdL\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n* Hemoglobin ≥ 8.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 80,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x upper limit of normal (ULN) ( ≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)\n* Calculated creatinine clearance ≥ 30 ml\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide tissue specimens for correlative research\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Prior metastasis-directed therapy\n* Any of the following prior therapies:\n\n  * Surgery ≤ 3 weeks prior to registration\n  * Chemotherapy for prostate cancer at any time\n  * Androgen receptor pathway inhibitor such as abiraterone, apalutamide, darolutamide, or enzalutamide in the last 2 years\n* Uncontrolled intercurrent non-cardiac illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Any other conditions that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for prostate cancer.\n* Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy ≤ 3 years prior to registration\n\n  * EXCEPTIONS: Curatively treated non-melanotic skin cancer or papillary thyroid cancer\n  * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment such as chemotherapy or antihormonal therapy for their cancer\n* History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias",{"count":76,"type":19},532,[78],"PHASE2","This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). It also studies the effects of salvage radiation therapy (sXRT) on prostate cancer and to see if radiation to the pelvis helps prevent prostate cancer from spreading elsewhere. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. sXRT is a targeted radiation treatment for the prostate, typically given when cancer possibly returns after surgery or radiation. Its goal is to destroy any tumor cells in the area. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT and sXRT may be effective in treating prostate cancer and preventing it from spreading elsewhere.",[81,82,83,25],"Recurrent Castration-Sensitive Prostate Carcinoma","Recurrent Prostate Cancer","Castration-resistant Prostate Cancer","2026-04-17",{"date":86,"type":31},"2026-04-20",{"date":88,"type":31},"2024-06-03",{"date":90,"type":19},"2031-02-28",{"name":92,"class":38},"Mayo Clinic",3,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":20,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":39},"100598615","phase-2-evaluating-in-home-cancer-therapy-versus-in-clinic-cancer-therapy-in-black-men-with-locally-advanced-biochemically-recurrent-and-metastatic-prostate-cancer-100598615","NCT07073794","Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer","A Phase 2 Pragmatic Clinical Trial to Evaluate Administration of Cancer Therapy in the Patients' Homes Versus in Clinic in Black Men With Advanced or Metastatic Prostate Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g., NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* Black or African American male patients with locally advanced, high risk, biochemical recurrent, or metastatic prostate cancer who are currently receiving or planning to start treatment with one or more of the eligible regimens. Patients may be on any combination of these regimens, provided that at least one is administered by a home health nurse \\[co-administration with second generation antiandrogens, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, or older antiandrogens are allowed but combinations of oral regimens only are not permitted\\]\n\n  * Androgen deprivation therapy (ADT):\n\n    * Leuprolide intramuscular (IM) or subcutaneous (SQ), 4 or 12 weeks cycle length\n    * Degarelix SQ, 4 weeks cycle length\n  * Chemotherapy: Cabazitaxel IV, 3 weeks cycle length\n  * Immunotherapy: Pembrolizumab IV, 3 weeks cycle length\n  * Bone modifying agent + any of the prostate cancer treatments:\n\n    * Zoledronic acid IV, 4 or 12 weeks cycle length\n    * Denosumab SQ, 4 or 12 weeks cycle length\n* Patients who are anticipated to continue the treatment regimen they are currently prescribed for at least 18 weeks following registration (if on chemotherapy or immunotherapy) or 24 weeks following registration (for all other treatment regimens)\n* Residing within the area serviced by supplier\n* Provide written informed consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 for patients on any qualifying treatment (tx) regimen; ECOG PS 0, 1, 2, or 3 for patients on ADT with or without second generation antiandrogen\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to follow birth control requirements for males of reproductive potential\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction ≤ 6 months\n  * Wound healing disorder\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with any severe infection within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed COVID-19 infection)\n* Anticipation of the need for major surgery during the course of study treatment\n\n  * Note: Concomitant radiation therapy during the study period is allowed\n* Not cleared for treatment in home via social stability screening\n* Patients who received at home treatment through involvement in another CCBW trial\n\n  * Note: Patients who enrolled in another CCBW trial but had to be withdrawn prior to initiating treatment in the home would still be eligible",{"count":102,"type":19},38,[78],"This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.",[25,106,54,107,108],"Locally Advanced Prostate Carcinoma","Stage III Prostate Cancer AJCC v8","Stage IV Prostate Cancer AJCC v8","2026-03-23",{"date":111,"type":31},"2026-03-25",{"date":113,"type":31},"2025-08-27",{"date":115,"type":19},"2028-08-27",{"name":92,"class":38},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":20,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":5},"100531862","phase-3-sbrt-versus-hypofractionated-radiotherapy-for-biochemically-recurrent-or-oligometastatic-prostate-adenocarcinoma-100531862","NCT06205316","SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma","Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy","Inclusion Criteria:\n\n* Histologically confirmed prostate adenocarcinoma at the time of surgery\n* Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer \\[AJCC\\] Criteria 8th edition \\[Ed.\\])\n* PSA post radical prostatectomy ≥ 0.1 and \\\u003C 2.0 ng\u002FmL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment\n* Patients must sign institutional review board (IRB) approved study specific informed consent\n* Patients must complete all required pre-entry tests within the specified time frames\n* Patients must be able to start treatment (ADT or radiation) ≤ 120 days of study registration\n* Patients must be ≥ 18 years old\n* Prostate cancer up to oligometastatic disease, up to 5 sites\n\nExclusion Criteria:\n\n* Previous pelvic radiation\n* Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng\u002FmL\n* Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)\n* Prior systemic chemotherapy for prostate cancer\n* History of proximal urethral stricture requiring dilatation\n* Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and\u002For interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)\n* History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months\n* On a transplant list\n* More than oligometastatic disease \\> 5 metastatic sites",{"count":125,"type":19},118,[51],"This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects. SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer, but with a shorter treatment time and possibly fewer side effects.",[25,129,130,131,132,107,108],"Oligometastatic Prostate Carcinoma","Recurrent Prostate Adenocarcinoma","Stage IIB Prostate Cancer AJCC v8","Stage IIC Prostate Cancer AJCC v8","2026-01-16",{"date":135,"type":31},"2026-01-20",{"date":137,"type":31},"2024-01-22",{"date":139,"type":19},"2030-01-22",{"name":92,"class":38},{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":20,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":39},"100443430","phase-2-modifying-metabolic-syndrome-and-cardiovascular-risk-for-prostate-cancer-patients-on-adt-using-a-risk-factor-modification-program-and-continuous-fitbit-monitoring-100443430","NCT05054296","Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring","Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Supervised Exercise Program and Continuous Fitbit Monitoring","Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Presence of metastatic disease documented on imaging studies (bone scan, computed tomography \\[CT\\] and\u002For magnetic resonance imaging \\[MRI\\]) or biochemical recurrence\u002Frefractoriness following local therapy (prostatectomy or radiation)\n* Stable or improving disease activity as demonstrated by stable or improving PSA over at least 2 months\n* On gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or status post-surgical castration for at least 3 months\n* Combination ADT with abiraterone or enzalutamide is permitted\n* Anticipation to remain hypogonadal for at least 6 months subsequently\n* Asymptomatic bone metastasis is permissible (exercise will be modified and patients monitored)\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n* Patients must be able to finish a maximal exercise stress test which will be assessed by cardiopulmonary exercise testing using a standardized protocol \\^70 supervised by a cardiologist\n* Hemoglobin \\>= 9.0 g\u002FdL independent of transfusion and\u002For growth factors within 3 months prior to enrollment\n* Platelet count \\>=75,000\u002FuL independent of transfusion and\u002For growth factors within 3 months prior to enrollment\n* Access to a smart phone with android or iPhone OS (iOS) operating systems\n* Able to speak and comprehend English\n\nExclusion Criteria:\n\n* Current use of any other systemic therapy for prostate cancer with the exception of gonadotrophin releasing hormone (GnRH) agonists\u002Fantagonists, abiraterone, enzalutamide, bisphosphonates or RANK-ligand inhibitors (for bone metastases) which are allowed\n* Any underlying comorbid medical or psychiatric condition, which in the opinion of the Investigator, will make participation in our exercise intervention hazardous or obscure the interpretation of adverse events\n* Inability to walk 400 meters or undertake upper and lower limb exercise, and resistance training in the previous 3 months\n* Chemotherapy treatment within 28 days of study enrollment\n* Symptomatic bone metastasis\n* Any investigational pharmaceutical products\n* Radiation therapy or surgical intervention for prior bone metastasis\n* Clinically significant active malignancy other than prostate cancer\n* Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\\>= 450 m\u002Fsec)\n* Clinically significant heart disease that may impact safety of independent or supervised exercise including preexisting coronary artery disease, myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes), New York Heart Association Class III-IV heart disease or cardiac ejection fraction measurement of \\\u003C 40% at baseline\n* Untreated symptomatic spinal cord compressions\n* Prisoners or subjects who are involuntarily incarcerated\n* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness",{"count":149,"type":19},200,[78],"This phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response to treatment (refractory) and are receiving androgen deprivation therapy. Balancing treatment efficacy, drug side effects, and competing comorbidities with prostate cancer is essential. This trial is being done to learn if an exercise program can help to improve metabolic syndrome and cardiovascular (heart) fitness in prostate cancer patients who are receiving androgen deprivation therapy.",[25,153,108,154,55],"Metastatic Prostate Adenocarcinoma","Stage IVA Prostate Cancer AJCC v8","2023-03-28",{"date":157,"type":31},"2023-03-29",{"date":159,"type":31},"2020-03-23",{"date":161,"type":19},"2027-02-02",{"name":163,"class":38},"M.D. Anderson Cancer Center"]