[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"androgen-deprivation-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:androgen-deprivation-therapy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,47,83,126,152,176,201,227,251,277],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100645327","effects-of-combined-training-in-prostate-cancer-patients-100645327",false,"NCT07680920","Effects of Combined Training in Prostate Cancer Patients","Effect of Combined Training on Quality of Life, Functional Capacity, Cardiovascular Function, and Body Composition in Prostate Cancer Patients Undergoing Androgen Suppression Therapy: a Randomized Controlled Clinical Trial","Proactive","Inclusion Criteria:\n\nClinical diagnosis of prostate cancer stages I-III; Currently undergoing androgen deprivation therapy (ADT); Aged 40 to 75 years; No participation in research involving physical exercise or any systematic physical exercise intervention during the four months preceding the intervention; Residence in the Greater Florianópolis region, Santa Catarina, Brazil; Provision of written informed consent.\n\nExclusion Criteria:\n\nCurrent participation in a structured physical exercise program; Presence of musculoskeletal disorders or other diseases that may prevent participation in the intervention or the assessment procedures.","MALE","40 Years","75 Years",{"count":21,"type":22},46,"ESTIMATED","INTERVENTIONAL",[25],"NA","Prostate cancer is the most prevalent type among men in Brazil, after non-melanoma skin cancer. One of the main treatment approaches is androgen suppression therapy (AST), which, although effective in controlling tumor growth, leads to several adverse effects such as erectile dysfunction, fatigue, reduced muscle mass, increased body fat percentage, decreased functional capacity and muscle strength, as well as a higher risk of cardiovascular events due to the sharp decline in testosterone and dihydrotestosterone. These factors significantly impair patients' quality of life. Physical exercise has been shown to mitigate such effects; however, in Brazil, only one study has so far evaluated the impact of exercise in men undergoing AST.\n\nGiven this context, the aim of the present study is to assess the effect of supervised physical exercise on quality of life, functional capacity, cardiovascular parameters, handgrip strength, and physical activity levels in men with prostate cancer undergoing AST. A randomized controlled clinical trial will be conducted, with patients allocated into an intervention group (IG) and a control group (CG). Data collection and the exercise intervention will take place at the Rehabilitation Center of the Sports Center at the Federal University of Santa Catarina (UFSC). The IG will participate in a supervised multicomponent exercise program including muscle strength, aerobic capacity, motor coordination, and flexibility, over 12 weeks, with 60-minute sessions three times per week.\n\nOutcomes will be assessed before and after the intervention, covering quality of life (SF-36, EORTC QLQ-BR30, and EORTC QLQ-PR25 questionnaires), functional capacity (submaximal treadmill test, six-minute walk test, timed-up and go, 30-second sit-to-stand, and modified sit-and-reach), cardiovascular parameters (office and ambulatory systolic and diastolic blood pressure, resting heart rate, heart rate variability, flow-mediated dilation, arterial stiffness, and carotid intima-media thickness), body composition, and physical activity level. Adverse events will be recorded weekly. For statistical analysis, sample characterization variables will be examined using Student's t-test, Chi-square, and Fisher's exact test, while intervention outcomes will be analyzed using the generalized estimating equations (GEE) model, with significance set at p\\\u003C0.05, both by intention-to-treat and per-protocol approaches.",[28,29],"Prostate Cancer Patients","Androgen Deprivation Therapy",[31,32,33,34],"prostate cancer","androgen suppression therapy","Physical exercise","combined exercise","NOT_YET_RECRUITING","2026-06-25",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":22},"2026-06-15",{"date":43,"type":22},"2027-06",{"name":45,"class":46},"Universidade Federal de Santa Catarina","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100629665","phase-3-radiotherapy-after-prostatectomy-for-node-positive-prostate-cancer-100629665","NCT07477626","Radiotherapy After Prostatectomy for Node Positive Prostate Cancer","Radiotherapy and Androgen Deprivation Therapy Versus Androgen Deprivation Therapy Alone After Prostatectomy for Node Positive Prostate Cancer (RADVAN): A Multicenter, Randomized Controlled Phase Ⅲ Trial","RADVAN","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed adenocarcinoma of the prostate.\n* Radical prostatectomy with pelvic lymph node dissection and pathologically confirmed positive pelvic lymph nodes (AJCC 8th edition: external iliac, internal iliac, obturator, presacral, periprostatic, and\u002For perirectal nodes).\n* ECOG performance status 0-2.\n* Started postoperative GnRH agonist or antagonist therapy for less than 1 year if receiving postoperative androgen deprivation therapy\\*.\n* Adequate major organ function, defined as:\n\nHemoglobin ≥ 90 g\u002FL Platelet count ≥ 75 × 10⁹\u002FL Total bilirubin ≤ 3 × ULN AST or ALT ≤ 5 × ULN\n\n* Use of effective contraception during the study and for 3 months after.\n* Written informed consent provided, with willingness and ability to comply with study visits, treatments, and procedures.\n\n  * Prior postoperative ARAT use ≤ 3 months is eligible after treatment discontinuation.\n\nExclusion Criteria:\n\n* Measurable pelvic recurrence on postoperative MRI or CT (RECIST 1.1, including prostate bed and lymph nodes).\n* Radiographically confirmed distant metastasis (M1a, M1b, or M1c).\n* Neoadjuvant hormonal therapy \\> 3 months before prostatectomy.\n* Malignancy within 5 years that may interfere with study safety or efficacy assessments.\n* Castration-resistant prostate cancer (CRPC) prior to enrollment per 2025 EAU criteria\n* Prior radiotherapy overlapping irradiation fields that may compromise normal tissue.\n* Serious comorbidities affecting study treatment.\n* Psychiatric disorders preventing understanding or compliance.\n* Any condition that, in the investigator's judgment, makes participation unsuitable.","18 Years",{"count":57,"type":22},372,[59],"PHASE3","The goal of this clinical trial is to evaluate whether the addition of pelvic radiotherapy to androgen deprivation therapy (ADT) can delay disease progression and improve survival outcomes in patients with pathologically confirmed regional lymph node-positive (pN1) prostate cancer after radical prostatectomy.\n\nThe main questions it aims to answer are:\n\n* Does ADT combined with pelvic radiotherapy improve biochemical recurrence-free survival (bRFS) compared with ADT alone in pN1 patients?\n* Does the addition of pelvic radiotherapy improve clinical progression-free survival, metastasis-free survival, overall survival, and prostate cancer-specific survival without unacceptable toxicity?\n\nResearchers will compare ADT plus pelvic radiotherapy with ADT alone to see if combined treatment improves disease control and long-term clinical outcomes.\n\nParticipants with positive lymph nodes after prostatectomy will be randomly assigned in a 2:1 ratio to receive ADT plus pelvic radiotherapy, or ADT alone. ADT will be administered for 2 years. Patients with radiologically detectable pelvic recurrence or distant metastases after radical prostatectomy will be excluded. Safety, adverse events, and health-related quality of life will be assessed during follow-up.",[62,63,64,29,65],"Prostate Cancer (Post Prostatectomy)","Radiotherapy; Image-Guided","Prostate Cancer Non-Metastatic","Lymph Node Positive",[31,67,68,69,70,71,72],"node positive","pN1","radiotherapy","androgen deprivation therapy","hormone therapy","prostatectomy","RECRUITING",{"date":75,"type":39},"2026-06-16",{"date":77,"type":39},"2026-03-20",{"date":79,"type":22},"2038-12-31",{"name":81,"class":46},"Sun Yat-sen University",13,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":95,"conditions":96,"keywords":115,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100589690","phase-2-proof-of-concept-trial-to-assess-the-efficacy-and-safety-of-fezolinetant-in-improving-vasomotor-symptoms-in-men-with-prostate-cancer-undergoing-androgen-deprivation-therapy-100589690","NCT06957691","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy (Fezo-ADT Trial)","Fezo-ADT","Inclusion Criteria:\n\n* Male sex\n* Age 40 years and older\n* Diagnosis of prostate cancer\n* Androgen deprivation therapy\n* Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week\n* Ability to sign the inform consent\n* Willing to use reliable methods of contraception if partner is of childbearing age\n* Ability to record hot flashes electronically\n\nExclusion Criteria:\n\n* Use of abiraterone acetate\n* Use of docetaxel and other chemotherapeutic agents\n* Liver cirrhosis\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal\n* Total bilirubin above the upper limit of normal\n* Glomerular filtration rate \\\u003C 30 mL\u002Fmin\n* Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics\n* Use of over-the-counter hormonal agents or herbal compounds\n* Current use of CYP1A2 inhibitors\n* Ingestion of alcohol within 2 weeks prior to the baseline visit\n* Inability to abstain from alcohol use during the study period.",{"count":92,"type":22},60,[94],"PHASE2","The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy.\n\nThe main questions it aims to answer are:\n\n* Does fezolinetant improve the frequency and severity of hot flashes?\n* Does fezolinetant cause any harm to the liver?\n* Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters?\n\nResearchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine.\n\nParticipants will:\n\n* Take fezolinetant or a placebo every day for 4 weeks\n* Visit the clinic once every 2 weeks for checkups and tests\n* Keep a diary of the number of times and intensity that they experience hot flashes",[97,98,99,100,101,102,103,104,105,106,107,108,109,29,110,111,112,113,114],"Prostate Cancer","Prostate Cancer (Adenocarcinoma)","Prostate Cancer Metastatic Disease","Prostate Cancer Recurrent","Prostate Carcinoma","Prostate Neoplasm","Prostate Adenocarcinoma","Prostate Cancer With Bone Metastasis","Vasomotor Disturbance","Vasomotor Symptoms","Vasomotor Symptoms (VMS)","Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","Vasomotor Symptoms; Hot Flashes","Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma","Androgen-deprivation Therapy","Hot Flashes","Hot Flushes","Hot Flushes and\u002For Sweats",[29,112,113,97,106],"2026-03-05",{"date":118,"type":39},"2026-03-09",{"date":120,"type":39},"2026-01-14",{"date":122,"type":22},"2028-12-31",{"name":124,"class":46},"Shehzad Basaria, M.D.",1,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":125},"100526150","phase-1-relugolix--enzalutamide-study-in-high-risk-prostate-cancer-100526150","NCT06130995","Relugolix + Enzalutamide Study in High-Risk Prostate Cancer","Phase IB Trial of Relugolix and Enzalutamide as Neoadjuvant\u002F Adjuvant to Local-regional Treatment in Patients With High-risk Locally Advanced Prostate CAncer (RENAPCA)","Inclusion Criteria:\n\n1. Capable of giving signed informed consent;\n2. Patients must be ≥18 years of age at the time of signing the informed consent form.\n3. Men with a diagnosis of adenocarcinoma of the prostate pathologically proven diagnosis with the following:\n\n   • Locally advanced high-risk prostate defined as i. PSA \\>20 ng\u002FmL or ISUP grade 4\u002F5 (Gleason score \\>7) or cT2c or ii. Any PSA, any ISUP grade, cT3-4 or cN+ (locally advanced)\n4. Have normal organ and bone marrow function measured at the screening visit including\n\n   * Platelets ≥100 × 103\u002Fmicroliter (μL);\n   * Hemoglobin ≥ 10.0 grams\u002FdL;\n   * Leukocytes (WBC) ≥ 3 × 103\u002FμL;\n   * Absolute neutrophil count ≥1.5 × 103\u002FμL;\n   * Serum AST and ALT ≤2.5 × upper limit of normal (ULN);\n   * Total bilirubin ≤1.5 ×ULN (unless values are consistent with Gilbert's syndrome for which the total bilirubin must be \\\u003C 3x ULN);\n   * Serum creatinine ≤ 1.5 × ULN; OR Measured or calculated creatinine clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n6. The participant has, in the opinion of the investigator, a life expectancy of at least 6 months.\n7. Male patients must be willing to use contraception during treatment and for 3 months after the last dose of study treatment when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.\n\nExclusion Criteria:\n\n1. History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6 months.\n2. Patients who are receiving any other investigational agents.\n3. Patients with distant metastatic cancer will be excluded from the study as intermittent hormonal therapy is not standard of care treatment for this population.\n4. Active secondary malignancies requiring treatment\n5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of study drugs\n6. Participants with uncontrolled intercurrent illness.\n7. Participant is unable to swallow pills.\n8. Not a candidate for surgical or radiation therapy",{"count":21,"type":22},[135],"PHASE1","The goal of this clinical trial is to test how effective and safe it is to use a combination of two medications, relugolix and enzalutamide, in patients with advanced prostate cancer. We want to see if this combination can help improve the chances of curing the cancer and make the patients live longer without the cancer getting worse.\n\nThe main questions we want to answer in this study are:\n\n* Can using relugolix and enzalutamide together help increase the chances of curing high-risk advanced prostate cancer?\n* Does this combination treatment help patients live longer without their cancer getting worse?\n\nParticipants in this study will be asked to take relugolix and enzalutamide as part of their cancer treatment. They will also undergo Radiation Therapy or prostatectomy, which are standard treatments for this type of cancer.",[29,138],"Locally Advanced Prostate Cancer",[140,141,142,143],"dose limiting toxicity (DLTs)","pathologic complete response (pCR)","minimal residual disease (MRD)","radiation therapy (RT)","2026-03-03",{"date":116,"type":39},{"date":147,"type":39},"2024-12-26",{"date":149,"type":22},"2030-01",{"name":151,"class":46},"University of Oklahoma",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":125},"100618715","men-with-prostate-cancer-optimizing-wellness-by-enhanced-relief-from-hot-flashes-with-acupuncture-100618715","NCT07335224","Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture","MPOWER: A Pilot Trial Among Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture","MPOWER","Inclusion Criteria:\n\n* Male\n* At least 18 years of age\n* Histologically or cytologically confirmed adenocarcinoma of prostate of any stage I-IV\n* Undergoing androgen deprivation therapy (ADT) and\u002For androgen receptor pathway inhibitors\n* Experiencing moderate to severe daily interference from hot flashes, as indicated by the Hot Flash Related Daily Interference Scale (score≥4)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Able to read, understand, and provide written informed consent\n\nExclusion Criteria:\n\n* Severe or uncontrolled concurrent disease, infection or co-morbidity that, in the opinion of the Investigator, would make the patient inappropriate for enrollment\n* Known hypersensitivity to the acupuncture needles\n* Any condition that in the opinion of the Investigator would impair the patients' ability to comply with the study procedures\n* Unable to comply with study requirements\n* Use of acupuncture for hot flashes within 6 months prior to enrollment",{"count":161,"type":22},24,[25],"Prostate cancer is the most common cancer among men in the United States. Many men with prostate cancer are treated with hormone therapy, also called androgen deprivation therapy (ADT). While this treatment is effective, it often causes bothersome side effects such as hot flashes, poor sleep, fatigue, and other physical and emotional symptoms. There is currently no standard treatment to help manage these side effects in men. Acupuncture is a non-drug treatment that has been shown to help reduce hot flashes and related symptoms in women receiving hormone therapy for breast cancer. However, much less is known about whether acupuncture is helpful for men receiving hormone therapy for prostate cancer. This study will test whether an acupuncture program, combined with usual lifestyle education, is feasible and acceptable for men undergoing ADT. The study will also explore whether acupuncture may help reduce hot flashes and improve related symptoms. A total of 24 men with prostate cancer receiving ADT will be randomly assigned to one of two groups: one group will begin acupuncture right away, and the other group will begin acupuncture after a delay, with regular check-ins during the waiting period. All participants will receive standard lifestyle education. Participants will be followed for about five months and will be asked to complete daily hot flash diaries, questionnaires about their symptoms and quality of life, and wear a Fitbit to track sleep. The results of this pilot study will help determine whether a larger study should be conducted to better understand the role of acupuncture in managing hormone therapy side effects in men with prostate cancer.",[112,165,106,29,166],"Acupuncture Therapy","Prostatic Neoplasms","2026-02-02",{"date":169,"type":39},"2026-02-04",{"date":171,"type":39},"2026-01-08",{"date":173,"type":22},"2027-06-30",{"name":175,"class":46},"Inova Health Care Services",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":125},"100590857","phase-2-fezolinetant-for-treating-hot-flashes-in-men-with-prostate-cancer-100590857","NCT06972875","Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer","Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Associated With Androgen-Deprivation Therapy in Men With Prostate Cancer (FLASH): A Phase 2 Study","FLASH","Inclusion Criteria:\n\nAge ≥ 18 years Men who are currently receiving Androgen Deprivation Therapy (ADT) for the treatment of prostate cancer. ADT is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists (e.g. leuprolide, degarelix, relugolix). Men receiving Androgen Receptor Pathway Inhibitors (ARPI) such as abiraterone, enzalutamide, apalutamide, and darolutamide are eligible.\n\nPatients must be on a stable dose of all hormonal therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration. Additional ARPI agents (e.g. abiraterone or enzalutamide) are allowed to be added during the Extension Phase of the trial, but not during the Treatment Phase.\n\nPatients receiving radiation therapy during the study period are eligible. An eligible patient must have bothersome hot flashes for ≥ 7 days prior to consent, resulting in an average of four or more hot flashes per day of sufficient severity to cause the patient to seek therapeutic intervention.\n\nLife Expectancy of 6 months or greater. Language: In order to complete the mandatory participant-completed measures, participants must be able to speak and read English.\n\nExclusion Criteria:\n\nCurrent or future planned use of any of the following agents during the study period: drugs that are not FDA approved for use in humans, any drug with category X interactions with fezolinetant; androgens, estrogens, progesterone analogs, or complementary\u002Falternative medicine taken for the purpose of managing hot flashes. Prior use of these agents is permitted as long as they are discontinued before registration. Stable dosing (≥ 1 month) of gabapentin, cholinergic agonists, cholinesterase inhibitors for other indications is permitted.\n\nHistory of cirrhosis Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 X ULN or total bilirubin \\> ULN eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 based on reported MDRD estimate. Current use of CYP1A2 inhibitors (fezolinetant is a substrate of CYP1A2).",{"count":185,"type":22},32,[94],"This study is for men with prostate cancer who are experiencing hot flashes due to treatments that lower testosterone. Hot flashes can affect your quality of life and make it harder for patients to continue their treatment, so researchers want to find a better way to manage them. The study is testing a drug called fezolinetant, which might help reduce hot flashes without using hormones. Fezolinetant is a drug that is currently approved for the treatment of hot flashes in menopausal women.",[189,29],"Prostate CA",[31,70,191,192],"hot flash","fezolinetant",{"date":194,"type":39},"2026-02-05",{"date":196,"type":39},"2025-12-18",{"date":198,"type":22},"2027-02",{"name":200,"class":46},"University of Vermont",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":125},"100464420","exercise-to-enhance-cardiovascular-health-among-black-prostate-cancer-patients-with-androgen-deprivation-therapy-100464420","NCT05327465","Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy","Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy: POWER Trial","Inclusion Criteria:\n\n* Patients must meet all criteria to be eligible, including travel to Dana-Farber Cancer Institute (DFCI) to collect research data to address the study question.\n* Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease\n* Histologically diagnosed of localized or metastatic prostate cancer\n* Have been receiving androgen deprivation therapy (ADT) (i.e., luteinizing hormone-releasing hormone \\[LHRH\\] agonist\u002Fantagonist and\u002For androgen receptor \\[AR\\] agonist\u002Fantagonist) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment\n* Self-identify as Black\n* Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist\n* Are without medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases\n* Speak English and\u002For Spanish\n* Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise\u002Fweek\n* Willing to travel to DFCI for necessary data collection\n* Ability to communicate and complete written forms in English and\u002For Spanish\n\nExclusion Criteria:\n\n* Are not receiving ADT (i.e., LHRH agonist\u002Fantagonist and\u002For AR agonist\u002Fantagonist)\n* Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise\n* Are not English or Spanish speaking\n* Patients with secondary diagnosis (with the exception of basal cell carcinoma)\n* Participate in more than 60 minutes of moderate or vigorous structured exercise\u002Fweek\n* Unable to travel to DFCI for necessary data collection\n* May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.",{"count":209,"type":22},62,[25],"The purpose of this research is to determine whether a 16-week culturally tailored, technology-based, aerobic and resistance exercise intervention improves cardiovascular risk factors in Black men diagnosed with prostate cancer and are undergoing androgen deprivation therapy (ADT), and whether it will also improve physical fitness and function, body composition, and outcomes such as quality of life, cancer symptoms, and self-esteem.\n\nParticipants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.",[29,97,213],"Prostate Cancer Metastatic",[215,216,213,217],"Androgen deprivation therapy","Localized Prostate Cancer","Exercise","2026-01-20",{"date":220,"type":39},"2026-01-22",{"date":222,"type":39},"2022-08-11",{"date":224,"type":22},"2026-12-31",{"name":226,"class":46},"Dana-Farber Cancer Institute",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":17,"minAge":234,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":237,"phases":4,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":4},"100603278","identifying-fundamental-mechanisms-of-skeletal-muscle-ageing-in-older-men-undergoing-androgen-deprivation-therapy-a-feasibility-study-100603278","NCT07134439","Identifying Fundamental Mechanisms of Skeletal Muscle Ageing in Older Men Undergoing Androgen Deprivation Therapy: a Feasibility Study","MASS-ADT","Inclusion Criteria:\n\n* Age ≥65 years old at time of recruitment\n* Able to provide informed consent to participate\n* Known prostate cancer due to be initiated on ADT for the first time (with or without Androgen Receptor Targeted Agents (ARTA) or radiotherapy), or initiated within two weeks prior to recruitment.\n* Individuals involved in other research will be eligible to participate so long as the other research does not involve potential changes to the standard ADT care the participant will be receiving and does not involve an intervention aimed at reducing the muscle atrophy associated with ADT.\n\nExclusion Criteria:\n\n* Systemic anti-cancer therapy within one year of recruitment (for prostate cancer or any other concomitant cancer)\n* Planned surgery (not including eye surgery or other minor surgery) within six months of ADT\n* Any other condition previous or current which, in the judgement of the responsible clinician, is likely to interfere with the trial \u002F assessments.\n* Lacks capacity to consent\n\nExclusion criteria for those consenting to optional muscle biopsy:\n\n* On treatment with clopidogrel, high-dose aspirin, dipyridamole or anticoagulants\n* Known bleeding disorder or platelets \\\u003C75x103\u002FmL","65 Years",{"count":236,"type":22},20,"OBSERVATIONAL","To find out whether it is possible to run a study looking at the underlying markers of ageing in muscle quality and quantity in men receiving Androgen Deprivation Therapy for prostate cancer treatment.\n\nTo determine the feasibility of conducting an observational study examining the association of fundamental biological markers of ageing with changes in body composition and skeletal muscle morphology following ADT in older men undergoing prostate cancer treatment.",[240,97,241,29],"Sarcopenia","Muscle Atrophy","2025-08-14",{"date":244,"type":39},"2025-08-21",{"date":246,"type":22},"2025-09",{"date":248,"type":22},"2026-12",{"name":250,"class":46},"Guy's and St Thomas' NHS Foundation Trust",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":17,"minAge":258,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":125},"100595448","impact-of-multimodal-telerehabilitation-in-rural-patients-with-metastatic-prostate-cancer-100595448","NCT07032584","Impact of Multimodal Telerehabilitation in Rural Patients With Metastatic Prostate Cancer","Impact of Multimodal Telerehabilitation on Reducing Disparities in Rural Survivors of Metastatic Prostate Cancer","Inclusion Criteria:\n\n1. Age 21 years or older\n2. Confirmed diagnosis of prostate cancer\n3. Men receiving standard-of-care ADT either for high-risk, locally advanced prostate cancer or as a part of multicomponent management of metastatic prostate cancer;\n4. Residing in a rural community defined by the Rural-Urban Commuting Area (RUCA) codes from the Federal Office of Rural Health Policy (4 and higher).\n\nExclusion Criteria:\n\n1. Have unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers, painful or unstable bony metastases, or recent skeletal fractures.\n2. Are engaged in a regular exercise rehabilitation program.\n3. Have relocation plans within the next 6 months\n4. Participate in another clinical trial related to prostate cancer or rehabilitation. The patients will also be required to have a working telephone line in their home or a cell phone.","21 Years",{"count":260,"type":22},74,[25],"People with prostate cancer may have a decreased quality of life due to the cancer itself and due to a lifesaving cancer treatment. Physical therapy, including regular exercise, helps patients with cancer to reduce disease symptoms and improve their quality of life. However, cancer rehabilitation programs in rural areas are not readily available and may require constant travel and significant financial resources, which may limit access to these services on a continuous basis.\n\nTechnology can allow patients residing in rural areas to exercise at home under the supervision of their rehabilitation team. However, it is unclear how effective this approach is. This research team will conduct a clinical trial in which half of the randomly chosen participants receiving hormonal prostate cancer therapy will use this new technology to exercise at home. Another half - will exercise at home without this new technology. After six months, the study will compare the quality of life and cancer symptoms in these two groups.\n\nThe investigators hope that this study will demonstrate that the patients who were helped by the new technology to exercise at home will have better fitness, fewer symptoms, and better quality of life. If the study demonstrates this in this project, other patients with cancer residing in rural areas will be able to take advantage of this technology. This approach can be extended to people with different diseases who have difficulties accessing medical care in rural areas to undergo required physical, cognitive, and occupational rehabilitation, and improve their quality of life.",[97,264,29],"Metastatic Prostate Cancer",[266,267],"Telerehabilitation","Rural Health","2025-07-29",{"date":270,"type":39},"2025-08-01",{"date":272,"type":39},"2025-05-27",{"date":274,"type":22},"2029-12",{"name":276,"class":46},"University of Utah",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":285,"minAge":55,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100499281","phase-3-short-versus-long-term-androgen-deprivation-therapy-with-salvage-radiotherapy-in-prostate-cancer-uroncor-0624-100499281","NCT05781217","Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624","Short Versus Long-term Androgen Deprivation Therapy Combined With Salvage Radiotherapy in Prostate Cancer Patients With Biochemical Recurrence After Prostatectomy: a Multicentre Phase III Randomised Controlled Trial","URONCOR 06-24","Inclusion Criteria:\n\n1. Patients with histologically-confirmed prostate cancer treated with radical prostatectomy. Patients who have not undergone lymph node dissection are eligible for inclusion.\n2. Biochemical recurrence after prostatectomy: BCR is defined as a PSA value ≥ 0.2 ng\u002FmL, with at least one confirmatory PSA determination ≥ two weeks after the first test (the confirmatory PSA level must be higher than the initial value). Patients with Gleason 8-10, pT3b or R1 are eligible for inclusion in the trial with PSA ≥ 0.15 ng\u002FmL; however, in patients with PSA \\> 0.4 ng\u002FmL, imaging tests (conventional CT and bone scans or advanced imaging techniques such as PSMA or choline PET\u002FCT) should be performed to check for metastases. In patients with PSA levels between 0.15 and 0.4 ng\u002FmL, no further tests are required to check for distant metastases prior to inclusion.\n3. Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al. (18):\n\n   CHARACTERISTICS INTERMEDIATE RISK (≥ 2) HIGH RISK(≥ 1)\n\n   PSA at diagnosis, ng\u002FmL 0.6-1.0 ≥1.0 PSA doubling time, months 6-12 \\\u003C 6 GLEASON \u002F ISUP 7\u002F3 ≥8\u002F≥4 TNM (prostatectomy specimen) pT2-3a pN0-Mx pT3b pN0-Mx Time to biochemical recurrence, months \\>18 \\\u003C18 Margins Positive Positive\n4. Testosterone level \\> 150 ng\u002FdL at inclusion\n5. ECOG 0-1\n6. Life expectancy \\> 5 years\n7. Signed informed consent\n\nExclusion Criteria:\n\n1. Presence of pN1 disease in the original surgical specimen\n2. Presence of macroscopic disease on imaging tests. If the PSA at diagnosis is \\> 0.4 ng\u002FmL, then imaging tests (CT and bone scan and\u002For PET\u002FCT or body magnetic resonance imaging \\[MRI\\]) are required.\n3. PSA \\\u003C0.2 or \\\u003C0.15 ng\u002FmL (if Gleason score=10, pT3b, or R1 in the radical prostatectomy specimen).\n4. Previous pelvic radiotherapy\n5. Radiotherapy contraindicated\n6. Ongoing treatment with ADT or PSA-modulating drugs (e.g., finasteride, dutasteride, high dose steroids)\n7. Inability to understand the treatment protocol or sign informed consent","ALL",{"count":287,"type":22},534,[59],"The optimal indication for ADT has long been a point of controversy, at least until the results of randomised trials comparing RT with and without ADT were published. NCCN guidelines and most retrospective series and left the decision to prescribe ADT in combination with RT to the discretion of the treating physician, despite a lack of clear scientific evidence to support this recommendation. The percentage of patients in those retrospective series who received hormone therapy ranged from 33% to 71%, but generally involved patients with adverse prognostic factors (Gleason score \\> 7, stage pT3-T4, PSA \\> 1 ng\u002FmL in cases with biochemical recurrence \\[BCR\\], and PSA doubling time \\[PSA-DT\\] \\\u003C 6 months). Despite the heterogeneity in those studies in terms of treatment duration, RT dose, and treatment volumes, most of the studies found that ADT significantly prolonged biochemical relapse-free survival (BRFS), especially in patients with PSA levels \\> 1 ng\u002FmL at recurrence.\n\nThe results of two randomised trials evaluating SRT with or without ADT were published in 2017, with both trials demonstrating a benefit for ADT in this clinical setting. A follow-up study confirmed the value of ADT in combination with SRT in terms of better PFS and, in the RTOG study, an improvement in overall survival (OS). Despite the lack of data from phase III trials regarding the influence of PSA-DT, the BRFS interval, and the Gleason score in terms of their effects on the clinical course of patients who develop BCR, there is strong evidence from other studies to support the use of these variables (together with age and comorbidities). Given the available evidence, we believe that these variables should be considered when determining the indications for ADT.\n\nIn line with the philosophy underlying the approach used by D'Amico to develop a risk classification system for prostate cancer patients at diagnosis, we propose three risk groups. According to Pollack et al. and Spratt et al., low-risk patients would not benefit from hormone therapy, especially long-term ADT, due to the deleterious effects of such treatment. By contrast, intermediate and high risk patients would be candidates for ADT combined with RT. However, the optimal duration of ADT in these patients (6 months vs. 2 years) remains undefined and needs to be determined prospectively in a randomised trial, similar to the approach used in the DART 05.01 trial.\n\nSRT and ADT are widely used in routine clinical practice to treat patients who develop BCR after prostatectomy. In this context, we intend to perform a multicentre, phase III trial to define the optimal duration of ADT (6 vs. 24 months).",[97,291,292,29,293],"Salvage Radiotherapy","Biochemical Recurrence","Metastases-free Survival","2023-11-17",{"date":296,"type":39},"2023-11-18",{"date":298,"type":39},"2023-03-14",{"date":300,"type":22},"2032-12",{"name":302,"class":46},"Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic",17]