[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-ii-prostate-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-ii-prostate-cancer-ajcc-v8":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,44,72,95,117,141,163,183,208,230,250,271],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100529790","focal-ablation-with-focal-cryotherapy-or-hifu-for-the-treatment-of-men-with-localized-prostate-cancer-100529790",false,"NCT06178354","Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer","A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer","Inclusion Criteria:\n\n* Ability to understand and willingness to sign an informed consent form\n* Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%)\n* Patients ≥ 18 years of age at time of consent\n* Life expectancy ≥ 5 years\n* Ability and stated willingness to adhere to the study visit schedule and other protocol procedures\u002Frequirements for the duration of the study\n\nExclusion Criteria:\n\n* Nodal or distant metastases\n* Prior treatment for prostate cancer\n* Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study\n* Known contraindications to general anesthesia\n* Uncorrectable coagulopathy\n* Significant active cardiac disease within the previous 6 months including: New York Heart Association (NYHA) class 4 congestive heart failure (CHF), unstable angina, or myocardial infarction\n* Any condition that would prohibit the understanding or rendering of informed consent\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial","MALE","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.",[26,27,28,29,30],"Localized Prostate Carcinoma","Stage I Prostate Cancer AJCC v8","Stage II Prostate Cancer AJCC v8","Stage IIIA Prostate Cancer AJCC v8","Stage IIIB Prostate Cancer AJCC v8","RECRUITING","2026-06-25",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":35},"2023-11-09",{"date":39,"type":20},"2029-06",{"name":41,"class":42},"University of California, Davis","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100554521","golf-recreational-exercise-for-enhanced-survivorship-in-prostate-cancer-survivors-100554521","NCT06500169","Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors","Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors Undergoing Hormone Therapy (GREENS)","GREENS","Inclusion Criteria:\n\n* First time, primary diagnosis of prostate cancer (PCa)\n* Currently receiving androgen deprivation therapy (ADT) and\u002For androgen receptor blocker) for more than 6 months\n* Older adult male: 55-85 years old\n* The ability to stand independently without external support\n* No or minimal golf experience (played \\\u003C 5 times in the past 10 years)\n* English speaking\n\nExclusion Criteria:\n\n* Second cancer diagnosis (excluding non-invasive skin cancers) or bone metastases\n* Prostatectomy less than 6 months prior to study enrollment (prostatectomy is not a requirement for study entry)\n* Symptomatic cardiovascular disease, active angina, uncontrolled hypertension (systolic blood pressure (SBP) \\> 160 or diastolic blood pressure (DBP) \\> 90, high resting pulse heart rate (HR) \\> 90), symptomatic orthostatic hypotension\n* Unstable asthma, exacerbated chronic obstructive pulmonary disease (COPD\\]\n* History of injury or orthopedic operation within the last 6 months\n* Movement disorders (e.g., Parkinson's disease (PD) or other neurological disorders), hemiparesis or paraparesis\n* Severe vision or hearing problems","55 Years","85 Years",{"count":55,"type":20},20,[23],"This clinical trial evaluates a golf recreational exercise program for enhancing survivorship in underrepresented prostate cancer survivors. Golf is a multimodal recreational activity that requires participants to utilize all muscle groups to perform the golf swing, walk over hilly and uneven terrain, maintain balance during putting and squat-like tasks. Physical activity and exercise are beneficial to physical function, cognitive function, psychosocial health, and overall quality of life during prostate cancer survivorship. These aspects of health are impacted by prostate cancer treatment, especially androgen deprivation therapy. Additionally, supervised, group-based activity programs facilitate participation in physical activity. Researchers want to examine the changes in functional abilities, psychosocial health, and quality of life following participation in in a golf program designed for prostate cancer survivors.",[26,59,60,28,61],"Locally Advanced Prostate Carcinoma","Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8","Stage III Prostate Cancer AJCC v8","2026-05-29",{"date":64,"type":35},"2026-06-03",{"date":66,"type":35},"2023-09-01",{"date":68,"type":20},"2027-12-31",{"name":70,"class":42},"University of Southern California",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":43},"100628996","focal-radiation-therapy-hdr-brachytherapy-for-the-treatment-of-prostate-cancer-100628996","NCT07468903","Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer","Phase II Trial of Focal Radiation Therapy in Patients With Prostate Cancer","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to registration via systematic biopsy\n* Multiparametric MRI (mp-MRI) confirmed lesion(s)\n* No distant or locally advanced disease on standard staging exams as indicated\n\n  * Bone scan and abdominopelvic computed tomography (CT)\u002FMRI OR\n  * PSMA PET\n* Eastern Cooperative Oncology Group (ECOG)\u002FZubrod performance status 0\u002F1 within 60 days prior to enrollment\n* Age ≥ 40\n\nExclusion Criteria:\n\n* Radiographic nodal or distant metastatic disease\n* Lesion(s) comprising \\> 40% of total prostate volume\n* Prior radiotherapy to the pelvis\n* Gleason score \\> 6 disease outside intended gross target volume (GTV)\u002Ftarget region(s)","40 Years",{"count":81,"type":20},45,[23],"This clinical trial tests the effect of focal radiation therapy, high dose rate-brachytherapy (HDR-BT), in treating patients with prostate cancer. Prostate cancer is the most diagnosed cancer in men and there are many treatments available, including surgery and radiation therapy. Although surgery and radiation therapy improve survival urinary and sexual function can be significantly affected and can be long lasting. HDR-BT, a type of focal radiation therapy also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving HDR-BT may be effective in providing local control while reducing side effects in patients with prostate cancer.",[85,60,28],"Prostate Adenocarcinoma","2026-05-19",{"date":88,"type":35},"2026-05-22",{"date":90,"type":35},"2026-05-11",{"date":92,"type":20},"2032-05-11",{"name":94,"class":42},"Jonsson Comprehensive Cancer Center",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":43},"100572444","phase-4-testosterone-replacement-therapy-for-the-treatment-of-low-testosterone-in-hypogonadal-men-with-localized-prostate-cancer-on-active-surveillance-100572444","NCT06733350","Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance","Investigating the Effect of Testosterone Replacement Therapy Among Hypogonadal Men With Localized Prostate Cancer on Active Surveillance","Inclusion Criteria:\n\n* Men aged ≥ 18 years\n* Men with localized prostate cancer are eligible for active surveillance (National Comprehensive Cancer Network \\[NCCN\\] very low, low, and intermediate favorable risk group)\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients with NCCN intermediate unfavorable, high risk, or very high-risk localized prostate cancer\n* For men being considered for Group 2 (TRT), Patients with contraindications to TRT, which include,\n\n  * Locally advanced or metastatic prostate cancer\n  * Male breast cancer\n  * Men with an active desire to have children\n  * Hematocrit levels \\> 54% or baseline hematocrit of 48-50%\n  * Uncontrolled or poorly controlled congestive heart failure\n  * IPSS (International Prostate Symptom Score) score \\> 19\n  * Family history of venous thromboembolism\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study",{"count":103,"type":20},600,[105],"PHASE4","This phase IV trial studies the effects of testosterone replacement therapy (TRT) on treatment outcomes in hypogonadal men with prostate cancer that has not spread to other parts of the body (localized) and who are on active surveillance (AS). AS in prostate cancer involves closely watching the patient's condition through regular physical exams and blood tests, but not giving treatment unless there are changes in test results. It can be a practical alternative to treatment in localized prostate cancer. Hypogonadal men have low testosterone associated with symptoms such as low libido and erectile problems. TRT can be used to treat hypogonadism by increasing testosterone levels, which may improve associated symptoms. TRT is often not used in men with prostate cancer due to concerns it may lead to the cancer growing or spreading. This may lead hypogonadal men to have a poor quality of life or to discontinue AS. TRT may improve treatment and quality of life outcomes in hypogonadal men with localized prostate cancer on active surveillance.",[26,27,28,61],"2026-05-13",{"date":110,"type":35},"2026-05-14",{"date":112,"type":35},"2025-01-15",{"date":114,"type":20},"2029-01-15",{"name":116,"class":42},"Roswell Park Cancer Institute",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":53,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":43},"100546042","accuracy-of-18f-rhpsma-73-pet-mri-for-prediction-of-lymph-node-metastasis-in-localized-high-risk-prostate-cancer-100546042","NCT06389786","Accuracy of 18F-rhPSMA-7.3 PET\u002F MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer","MC230504 Safe Omission of Pelvic Lymph Node Dissection (SOuND ) During Radical Prostatectomy: Diagnostic Accuracy of rhPSMA-7.3(18F) PET\u002FCT, mpMRI and Patient Clinical Factors to Predict Lymph Node Metastasis","Inclusion Criteria:\n\n* Male subjects ≥ 30 and ≤ 85 years old\n* Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy with extended lymph node dissection)\n* Primary diagnosis of untreated American Urological Association (AUA) guidelines high-risk localized prostate cancer, hormone-naïve prostate cancer via contrast enhanced prostate MRI + tissue sampling\n* Planned elective radical prostatectomy with extended pelvic lymph node dissection\n* Clinical oligometastatic disease with ≤ 3 nodes positive on preoperative standard of care imaging of prostate region within 6 months of surgery\n* Patient agrees to comply with the investigator instructions\n* Patient agrees to comply with the follow-up surveillance schedule\n* Have ability to provide full written consent\n\nExclusion Criteria:\n\n* High-risk cancer planned for neoadjuvant therapy\n* Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study\n* Patients that have had prior hormonal therapy such as Lupron or oral antiandrogens ≤ 12 weeks prior to registration\n* Clinical oligometastatic disease with \\> 3 nodes positive preoperative standard of care imaging of prostate region\n* Previous history of pelvic radiation\n* Patients with obesity defined as body mass index (BMI) \\> 40 kg\u002Fm\\^2\n* History of prior laparoscopic inguinal hernia repair with mesh\n* Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period\n* Inability to lie still for 75 minutes during 18F-rhPSMA-7.3 PSMA PET-MRI imaging\n* Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments\n* Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment\n* Received administration of an investigational drug within 30 days prior to study registration, and\u002For has planned administration of another investigational product or procedure during participation in this study","30 Years",{"count":126,"type":20},50,[23],"This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \\[PET\\]\u002Fmagnetic resonance imaging \\[MRI\\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET\u002Fcomputed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET\u002FCT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET\u002F MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy.",[26,130,27,28,61,131],"Oligometastatic Prostate Carcinoma","Stage IVA Prostate Cancer AJCC v8","2026-04-01",{"date":134,"type":35},"2026-04-06",{"date":136,"type":35},"2024-06-11",{"date":138,"type":20},"2027-05-31",{"name":140,"class":42},"Mayo Clinic",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},"100541068","adaptive-radiation-therapy-art-stereotactic-ablative-body-radiotherapy-sabr-for-primary-localized-prostate-cancer-100541068","NCT06325046","Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer","ART of SABR: A Randomized Phase II Trial of Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer: Two Versus Five Fractions","Inclusion Criteria:\n\n* Gender assigned male at birth: age ≥ 18 years\n* Histological confirmation of prostate adenocarcinoma\n* National Comprehensive Cancer Network (NCCN) (Prostate Cancer version 4.2022) low- to intermediate-risk prostate adenocarcinoma\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Signed informed consent\n* Willing to complete requirements for follow-up (during active monitoring phase)\n\nExclusion Criteria:\n\n* NCCN (Prostate Cancer version 4.2022) very low-, high-, or very high-risk prostate adenocarcinoma\n* Prior definitive treatment of prostate cancer including radiotherapy, prostatectomy, cryotherapy, or high intensity focused ultrasound (HIFU)\n* Prior bladder outlet obstruction procedures including transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), transurethral vaporesection of the prostate (TUVRP), etc.\n* Metastatic disease by conventional or molecular imaging\n* Contraindications to radiation therapy (RT) including uncontrolled inflammatory bowel disease, ATM mutation, and Xeroderma pigmentosum mutation\n* Concurrent antineoplastic agents (chemotherapy)\n* Previous or concurrent malignancy other than non-melanoma skin cancer, indolent lymphoma, or chronic myelogenous leukemia, unless continuously disease-free ≥ 5 years\n* Medical or psychiatric conditions that preclude informed decision-making or adherence with the protocol-defined treatment or follow-up\n* Prostate gland volume \\> 80 cc based on magnetic resonance imaging (MRI), and\u002For International Prostate Symptom Score (IPSS) composite score \\> 17\n* Body weight \\> 200 kilogram\n* Known allergy or sensitivity to polyethylene glycol (PEG) or iodine",{"count":149,"type":20},144,[23],"This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR 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. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR.",[153,27,28,61],"Localized Prostate Adenocarcinoma","2026-03-26",{"date":156,"type":35},"2026-03-31",{"date":158,"type":35},"2024-08-15",{"date":160,"type":20},"2031-08-30",{"name":140,"class":42},5,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":43},"100614195","image-guidance-and-online-adaptation-with-stereotactic-body-radiation-therapy-for-the-treatment-of-localized-prostate-cancer-manticore-trial-100614195","NCT07276438","Image-Guidance and Online Adaptation With Stereotactic Body Radiation Therapy for the Treatment of Localized Prostate Cancer, MANTICORE Trial","MRI- or CT-Guidance and Online Adaptation With Stereotactic Radiotherapy for Prostate Cancer (MANTICORE)","Inclusion Criteria:\n\n* Age ≥ 18\n* Histologically confirmed, clinically localized adenocarcinoma of the prostate\n* Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping\n\n  * Advanced imaging studies (i.e. prostate-specific membrane antigen \\[PSMA\\] positron emission tomography \\[PET\\]\u002FCT and fluciclovine PET\u002FCT scan) can supplant a bone scan if performed first\n* No evidence of metastatic disease in lymph nodes above the bifurcation of the renal arteries, or in bones or visceral organs (nodal disease identified on a PSMA PET\u002FCT scan below the bifurcation of the renal arteries are amenable)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* No indication for urgent or emergent radiation\n* Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator\n* Prior cryosurgery, high-intensity focused ultrasound (HIFU), brachytherapy, or other ablative treatments of the whole prostate\n* Prior pelvic radiotherapy\n* History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data",{"count":171,"type":20},186,[23],"This clinical trial studies the side effects of image-guidance and online adaptation with stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate adenocarcinoma that has not spread to other parts of the body (localized). Image-guided SBRT is a standard treatment for localized prostate cancer. This treatment uses imaging of the cancer within the body to define and localize the area to be treated with the radiation. Imaging can be obtained using either computed tomography (CT), magnetic resonance imaging (MRI), or a combination of the two. Typically, with SBRT, a radiation plan is developed based on the CT or MRI images obtained before treatment begins and adjustments are not made to the plan during treatment. However, anatomy can be different from day-to-day which may cause radiation to be delivered to the normal surrounding structures and possibly more side effects. During image-guided SBRT with online adaptation, the initial radiation plan is designed similarly; however, when the patient presents for radiation, the attending radiation oncologist, a dosimetrist, and a medical physicist \"re-optimize\" the radiation plan using the current anatomy of the day, meaning the changes in bladder and prostate size\u002Fshape are taken into account. The initial plan and the re-optimized plan are then compared, and the plan that has the optimal balance between delivering a tumor killing dose of radiation and minimizing radiation dose to normal surrounding structures is delivered. Image-guidance and online adaptation with SBRT may lower side effects and be a safer way to treat localized prostate adenocarcinoma.",[153,27,28,61],"2026-02-03",{"date":177,"type":35},"2026-02-05",{"date":179,"type":35},"2025-12-01",{"date":181,"type":20},"2032-12-31",{"name":94,"class":42},{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":191,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100503704","phase-3-vitamin-d-for-prostate-endocrine-therapy-100503704","NCT05838716","Vitamin D for Prostate Endocrine Therapy","High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients","ViPER","Inclusion Criteria:\n\n* Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed)\n* Be age 50 years or older\n* Be starting ADT or have received their first ADT treatment in the past 6 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone \\[LHRH\\] antagonists and LHRH agonists are permitted)\n* Have a total serum vitamin D between 10 and 32 ng\u002Fml\n* Have a total serum calcium of less than or equal to 10.5 mg\u002Fdl\n* Have a normal GFR (glomerular filtration rate \\> 30ml)\n* Agree not to take calcium and\u002For vitamin D supplements for the duration of the intervention other than those provided by the study\n* Be able to provide written informed consent\n* Be able to swallow pills and capsules\n* Be able to speak and read English\n\nExclusion Criteria:\n\n* Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or intravenous (IV) bisphosphonates, denosumab, or teriparatide prior to enrollment\n* Have a diagnosis of stage IV chronic kidney disease\n* Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg\u002Fdl)\n* Have a history of hypercalcemia or vitamin D toxicity\u002Fsensitivity","50 Years",{"count":193,"type":20},240,[195],"PHASE3","This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks of bone. A lack of vitamin D can lead to bone diseases such as osteoporosis or rickets. This trial may help researchers determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.",[27,28,61,131],"2026-01-14",{"date":200,"type":35},"2026-01-15",{"date":202,"type":35},"2023-12-14",{"date":204,"type":20},"2029-04-29",{"name":206,"class":42},"University of Rochester",51,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":216,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":43},"100588351","feasibility-and-effect-of-wrapping-nerves-with-a-multi-layer-perinatal-tissue-allograft-during-prostatectomy-100588351","NCT06940271","Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy","RAP: Prospective Pragmatic Multi-Site Trial Evaluating the Feasibility and Effect of Wrapping the Cavernous Nerves With a Novel Multi-Layer Perinatal Tissue Allograft During Prostatectomy","RAP","Inclusion Criteria:\n\n* Male subjects with age ≥ 45\n* Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy)\n* Primary diagnosis of organ confined (i.e. localized) untreated prostate cancer\n* Planned elective radical prostatectomy with bilateral nerve sparing technique\n* Negative urinalysis within 30 days prior to date of surgery\n* Patient has no erectile dysfunction (SHIM score ≥ 19) at the time of consultation\n* Willing to comply with instruction of the investigator\n* Willing to comply with follow-up surveys\n* Ability to provide written consent\n* Negative urinary tract infection at the time of consultation\n* Interest in penetrative sexual intercourse\n\nExclusion Criteria:\n\n* High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles\n* Unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and\u002For injectable medications\n* History of \\>14 days treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period\n* Prior hormonal therapy such as Lupron or oral anti-androgens\n* Poor urinary control at baseline requiring the use of pads for leakage\n* Previous history of pelvic radiation\n* Previous history of simple prostatectomy or transurethral prostate surgery\n* Patients with obesity defined as body mass index (BMI) \\> 40 kg\u002Fm\\^2\n* History of open pelvic surgery ≤ 5 prior to registration (except for hernia repair)\n* Scheduled to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period\n* Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments\n* Has any condition(s) which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment\n* In the opinion of the principal investigator (PI), has a history of drug or alcohol abuse ≤ 12 months prior to registration\n* Allergic to aminoglycoside antibiotics (such as gentamicin and\u002For streptomycin)\n* Received administration of an investigational drug within 30 days prior to registration, and\u002For has planned administration of another investigational product or procedure during participation in this study","45 Years",{"count":218,"type":20},25,[23],"This clinical trial studies whether a new multi-layer perinatal tissue allograft, MLG-Complete (Trademark), can be used to improve complications after nerve-sparing robot-assisted radical prostatectomy (RARP) in patients with prostate cancer that has not spread to other parts of the body (localized). Two major complications that can happen after complete surgical removal of the prostate (radical prostatectomy) include erectile dysfunction and urinary incontinence, both of which greatly affect a patient's quality of life and social well-being. The goal of nerve-sparing radical prostatectomy is to preserve erectile and urinary function, but damage to the surrounding nerves and blood vessels can still occur causing the patient to experience the complications. An allograft is the transplant of an organ, tissue, or cells from one individual to another individual of the same species who is not an identical twin. The MLG-Complete allograft is made up of perinatal tissue and is placed on the nerve bundles during a nerve-sparing RARP. It is meant to serve as a barrier and provide coverage to the nerve bundles from the surrounding environment, which may improve post-nerve-sparing RARP complications.",[26,27,28,61],"2025-11-07",{"date":224,"type":35},"2025-11-10",{"date":226,"type":35},"2025-08-14",{"date":228,"type":20},"2030-07-30",{"name":140,"class":42},{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":43},"100592563","computed-tomography-guided-stereotactic-body-radiation-therapy-with-intrafraction-motion-monitoring-for-the-treatment-of-localized-prostate-cancer-illusion-trial-100592563","NCT06995053","Computed Tomography-Guided Stereotactic Body Radiation Therapy With Intrafraction Motion Monitoring for the Treatment of Localized Prostate Cancer, ILLUSION Trial","Image-Guidance With Triggered Beam Hold To Implanted Fiducial Markers or Hypersight for Stereotactic Body Radiotherapy for Prostate Cancer (ILLUSION)","ILLUSION","Inclusion Criteria:\n\n* Histologically confirmed, clinically localized adenocarcinoma of the prostate\n* No evidence of metastatic disease in lymph nodes above the bifurcation of the renal arteries, or in bones or visceral organs (nodal disease identified on a prostate-specific membrane antigen \\[PSMA\\] positron emission tomography \\[PET\\]\u002FCT scan below the bifurcation of the renal arteries are amenable)\n* Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping\n* Advanced imaging studies (i.e. PSMA PET\u002FCT and fluciclovine PET\u002FCT scan) can supplant a bone scan if performed first\n* Age ≥ 18\n* Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator\n* Prior whole gland cryosurgery, high-intensity focused ultrasound (HIFU) or brachytherapy of the prostate\n* Prior pelvic radiotherapy\n* History of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia\n* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data",{"count":239,"type":20},80,[23],"This clinical trial studies the side effects of computed tomography (CT)-guided stereotactic body radiation therapy (SBRT) with intrafraction motion monitoring and to see how well it works in treating patients with prostate cancer that has not spread to other parts of the body (localized). In CT-guided SBRT, x-ray-based imaging and cone-beam CTs are used to define and localize the area to be treated with SBRT. 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. A recent randomized trial showed that while SBRT is associated with less urinary incontinence and erectile dysfunction than complete surgical removal of the prostate, there are more urinary irritative side effects and more bowel side effects than with surgery. One source of uncertainty in SBRT that may contribute to genitourinary (GU) and gastrointestinal (GI) side effects is the necessity of treating a \"margin\" of volume around the prostate to account for its movement during SBRT. Intrafraction motion monitoring is any technique or system designed to track the movement of the body and target during fractions of external beam radiation to keep the beam on target. This allows for the patient to be repositioned, if needed, to ensure delivery of the SBRT to only the planned treatment area. CT-guided SBRT with intrafraction motion monitoring may lower GU and GI side effects by allowing tighter margins, as has been demonstrated with magnetic resonance imaging (MRI)-guided SBRT.",[153,27,28,61],"2025-11-06",{"date":224,"type":35},{"date":246,"type":35},"2025-06-27",{"date":248,"type":20},"2036-09-01",{"name":94,"class":42},{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":216,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":21,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":43},"100472951","mri-guided-transurethral-urethral-ultrasound-ablation-for-the-treatment-of-low-to-intermediate-grade-prostate-cancer-100472951","NCT05438563","MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer","Focal Prostate Ablation for Low to Intermediate Grade Cancer Utilizing TULSA Profound System","Inclusion Criteria:\n\n* Male\n* Age 45-80 years, with \\> 10 years life expectancy\n* Biopsy-confirmed, NCCN \\[Gleason Grade (GG) 1, favorable GG 2 and unfavorable GG3\\] intermediate-risk prostate cancer\n* Stage =\\\u003C T2c, N0, M0\n* International Society of Urological Pathology (ISUP) grade group 1, 2, or 3 disease on transrectal ultrasonography (TRUS)-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy \\[minimum 3 cores from each Prostate Imaging-Reporting and Data System (PI-RADS) version (v)2 category \\>= 3 lesion\\]. Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline\n* Prostate specific antigen (PSA) =\\\u003C 20 ng\u002FmL reported within 3 months of baseline\n* Treatment naive\n* Planned ablation volume \\\u003C 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline\n\nExclusion Criteria:\n\n* Inability to undergo MRI or general anaesthesia\n* Suspected tumour \\> 30 mm from the prostatic urethra or \\\u003C 14 mm from the prostatic urethra\n* Prostate calcifications \\> 3 mm in maximum extent obstructing ablation of tumor on low-dose pelvic computed tomography (CT)\n\n  * Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcification. Imaging for calcification screening must be dated within 1 year of baseline visit\n* Unresolved urinary tract infection or prostatitis\n* History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder\n* Artificial urinary sphincter, penile implant or intraprostatic implant\n* Less than 10 years life expectancy\n* Patients who are otherwise not deemed candidates for radical prostatectomy (RP)\n* Inability or unwillingness to provide informed consent\n* History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices","80 Years",{"count":19,"type":20},[23],"This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with low to intermediate grade prostate cancer. MRI-guided TULSA ablation is a minimally invasive procedure that uses an ultrasound device guided by MRI imaging to deliver high-energy sound waves, producing very high temperature to ablate (destroy) tumor cells in a targeted manner. The MRI-guided TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.",[262,27,28],"Prostate Carcinoma","2025-09-03",{"date":265,"type":35},"2025-09-09",{"date":267,"type":35},"2022-04-06",{"date":269,"type":20},"2027-03-07",{"name":140,"class":42},{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":43},"100521259","phase-2-hormone-therapy-apalutamide-and-image-guided-stereotactic-body-radiation-therapy-for-the-treatment-of-patients-with-prostate-cancer-heatwave-trial-100521259","NCT06067269","Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial","High Precision Stereotactic Radiotherapy to the Whole Prostate With Focal Boost and Varying Hormonal Therapy (HEATWAVE)","HEATWAVE","Inclusion Criteria:\n\n* Confirmed diagnosis of prostate adenocarcinoma\n* Age ≥ 18\n* Classified as having National Comprehensive Cancer Network unfavorable intermediate risk prostate cancer (i.e., \\[a\\] 2 of the following: PSA 10-20 ng\u002FmL, clinical T category 2b-2c, or International Society of Urological Pathology \\[ISUP\\] grade group 2; \\[b\\] OR any 1 of \\[a\\] with ISUP grade group 3 disease; OR \\[c\\] any 1 of \\[a\\] with 50% or more cores on systematic biopsy showing prostate cancer)\n* Have a Decipher genomic classifier score\n* Have at least one dominant intraprostatic lesion visible on multiparametric MRI (Prostate Imaging-Reporting and Data System \\[PI-RADS\\] version 2.1 score 4 or 5)\n* Have underwent a prostate specific membrane antigen (PSMA) positron emission tomography\u002Fcomputed tomography (PET\u002FCT)\n* Have total testosterone \\>= 150 ng\u002FdL\n* Adequate performance status (Eastern Cooperative Oncology Group \\[ECOG\\] 0-1)\n* Hemoglobin ≥ 9.0 g\u002FdL, independent of transfusion and\u002For growth factors within 3 months prior to randomization (at screening)\n* Platelet count ≥ 100,000 x 10\\^9\u002FuL independent of transfusion and\u002For growth factors within 3 months prior to randomization (at screening)\n* Serum albumin ≥ 3.0 g\u002FdL (at screening)\n* Glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin (at screening)\n* Serum potassium ≥ 3.5 mmol\u002FL (at screening)\n* Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \\> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible) (at screening)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\\u003C 2.5 x ULN (at screening)\n* Medications known to lower the seizure threshold (see list under prohibited medications) must be discontinued or substituted at least 4 weeks prior to study entry\n\nExclusion Criteria:\n\n* Any evidence of spinal cord compression (radiological or clinical)\n* Prior pelvic malignancy\n* Prior pelvic radiation\n* Concurrent malignancy other than adequately treated basal cell or squamous cell skin cancer, non-muscle invasive bladder cancer (NMIBC), or any other cancer in situ currently without evidence of recurrence or progression\n* Inability to undergo radiotherapy, or hormonal therapy\n* Primary small cell carcinoma of the prostate (prostate adenocarcinoma with neuroendocrine differentiation is allowed)\n* Inflammatory bowel disease or active collagen vascular disease\n* History of any of the following:\n\n  * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \\[CNS\\] or meningeal disease which may require treatment with surgery or radiation therapy)\n  * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization\n* Current evidence of any of the following:\n\n  * Uncontrolled hypertension\n  * Gastrointestinal disorder affecting absorption\n  * Known active infection (eg, human immunodeficiency virus \\[HIV\\] or viral hepatitis)\n  * Any condition that in the opinion of the investigator would preclude participation in this study\n  * Treatment with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, a dose reduction of the CYP2D6 substrate may be considered\n  * Baseline moderate and severe hepatic impairment (Child Pugh class B \\& C)",{"count":280,"type":20},95,[282],"PHASE2","This phase II trial evaluates apalutamide in combination with image-guided stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate cancer. Prostate cancer usually needs the hormone testosterone to grow. Apalutamide is a hormone therapy that blocks the effect of testosterone on prostate tumor cells. This may help stop the growth of tumor cells that need testosterone to grow. Image-guided SBRT is a standard treatment for some types of prostate cancer. This treatment combines imaging of cancer within the body, with the delivery of therapeutic radiation doses produced on a linear accelerator machine. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Combining apalutamide with image-guided SBRT may increase a prostate cancer patient's chances of achieving an extremely low prostate specific antigen response, which is an early predictor of disease cure.",[85,28,29,30],"2025-07-11",{"date":287,"type":35},"2025-07-15",{"date":289,"type":35},"2024-03-28",{"date":291,"type":20},"2027-12-01",{"name":94,"class":42}]