Clinical trials: Androgen Deprivation Therapy
Prostate Cancer, Advanced Prostate Cancer
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
This research study is being done to determine the rate of testosterone recovery after completing two years of treatment with the combination of relugolix and darolutamide as well as to assess the safety of the drugs when…
- Conditions
- Prostate Cancer, Advanced Prostate Cancer, Hormone Sensitive Prostate Cancer
- Trial name
- NCT06463457
- Testing
- Darolutamide, Relugolix
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Atish Choudhury, MD
Biochemically Recurrent Prostate Cancer
A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies
Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy…
- Trial name
- ARASTEP (NCT05794906)
- Testing
- Darolutamide (BAY1841788, Nubeqa), ADT
- Where
- 226 sites in United States, Australia and 21 more
- Volunteers
- 985 people
- Sponsor
- Bayer
Prostate Cancer, Metabolic Syndrome
Akkermansia Muciniphilia and Metabolic Side Effects of ADT
The overriding objectives of this study are: 1. Primary outcomes: 1. To confirm that administration of oral acetate increases the proportion of A.
- Conditions
- Prostate Cancer, Metabolic Syndrome, Obesity, Cardiovascular Morbidity
- Trial name
- NCT05802121
- Testing
- Apple Cider Vinegar
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Western University
Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma
Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study
This phase II trial studies how well androgen deprivation therapy and apalutamide with or without radiation therapy works for the treatment of prostate cancer that has a rise in the blood level of prostate-specific antigen (PSA)…
- Conditions
- Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Oligometastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8
- Trial name
- NCT04585932
- Testing
- Apalutamide, Degarelix, Leuprolide Acetate
- Where
- United States
- Sponsor
- M.D. Anderson Cancer Center
Castration Sensitive Prostate Cancer, Metastatic Prostate Cancer
A Study Testing if Patients With Advanced Prostate Cancer Who Are Responding Well to Combination Treatment Can Safely Reduce Their Medication to a Single Hormone Therapy, Compared to Continuing Their Current Drugs
The goal of this randomized comparative study (a study where participants are placed into groups by chance) is to find out if reducing treatment to androgen deprivation therapy (ADT)-a treatment that lowers testosterone-by itself…
- Trial name
- STEPDOWNmHSPC (NCT07838753)
- Testing
- De-escalation strategy, Continuation of initial Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) combination therapy at standard doses
- Where
- India
- Volunteers
- 170 people
- Sponsor
- Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
Prostate Cancer, Castration-Resistant Prostate Cancer
Testosterone Therapy in Castration Resistant Prostate Cancer
This is an open-labeled, single-arm, interventional pilot study. It is being done to determine the feasibility of the administration of transdermal testosterone alternating with enzalutamide, as well as the safety and efficacy.
- Trial name
- NCT03734653
- Testing
- Transdermal Testosterone, Standard of Care, Enzalutamide
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Colorado, Denver
Prostate Cancer
Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy
This research study is evaluating the impact and feasibility of a 12-week brisk walking and moderate strength training exercise intervention including a virtual component in men who are initiating androgen deprivation therapy…
- Trial name
- NCT03070145
- Testing
- Exercise Intervention
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Dana-Farber Cancer Institute
Prostate Cancer
Behavioral Exercise TRaining for Men Undergoing Androgen Depr Therapy for Prostate Ca
To refine a remote behavioral exercise training intervention for testing in a larger randomized trial.
- Trial name
- BETR-PC (NCT06250751)
- Testing
- Behavioral Exercise Training (BET) intervention
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Virginia Commonwealth University
High-risk Prostate Cancer, Prostate Cancer
Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery
This is a prospective phase II study to assess the efficacy and toxicity of HSV-tk+ valacyclovir gene therapy in combination with androgen deprivation therapy, brachytherapy, external beam radiotherapy, and prostatectomy in…
- Trial name
- NCT03541928
- Testing
- HSV-Tk, Valacyclovir, Bicalutamide
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- The Methodist Hospital Research Institute
Castration Resistant Metastatic Prostate Cancer
Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression
Asymptomatic men without pain due to prostate cancer progressing with metastatic CRPC after treatment with combination or sequential ADT + Abi will be treated on a randomized, open label study to determine if sequential treatment…
- Trial name
- NCT04363164
- Testing
- Testosterone cypionate, Enzalutamide, Testosterone enanthate
- Where
- 6 sites in United States
- Volunteers
- 150 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Metastatic Prostate Cancer, Recurrent Prostate Cancer
Impact of Atorvastatin on Prostate Cancer Progression During ADT
This randomized double-blind placebo-controlled trial tests whether intervention with atorvastatin delays development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for prostate cancer.
- Trial name
- ESTO2 (NCT04026230)
- Testing
- Atorvastatin 80mg
- Where
- 10 sites in Denmark, Estonia and 2 more
- Volunteers
- 400 people
- Sponsor
- Tampere University Hospital
Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
This phase II trial studies the effect of talazoparib with androgen deprivation therapy and abiraterone in treating castration sensitive prostate cancer patients.
- Conditions
- Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
- Trial name
- NCT04734730
- Testing
- Abiraterone Acetate, Bicalutamide, Degarelix
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- City of Hope Medical Center
Prostate Cancer
Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens.
- Trial name
- NCT00460031
- Testing
- ketoconazole, lenalidomide, therapeutic hydrocortisone
- Where
- 6 sites in United States
- Volunteers
- 34 people
- Sponsor
- Case Comprehensive Cancer Center
Prostate Cancer, Prostate Adenocarcinoma
EBRT and HDR Brachytherapy for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer
This study is trying to find out if the combination of Androgen deprivation therapy (ADT), MRI guided high dose radiation (HDR) brachytherapy treatment (internal radiation implant procedure) and external beam radiation therapy…
- Trial name
- Prostate005 (NCT04465500)
- Testing
- External Beam Radiation, HDR Brachytherapy, Androgen Deprivation Therapy
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Virginia
Insulin Resistance, Prostate Cancer
Insulin Resistance Following ADT for Prostate CA
Prostate cancer is the most common cancer in men in the United States. Suppression of male hormone levels by using GnRH agonist ("hormone blocking therapy") for a few years is routinely used to treat prostate cancer.
- Trial name
- NCT04658849
- Testing
- Pioglitazone 30 Mg Oral Tablet
- Where
- United States
- Sponsor
- St. Louis University
Prostate Cancer
Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer
Genistein is a natural supplement that comes from soy. The purpose of this study is to see if genistein has any effect on preventing or reducing heart disease and diabetes risk in men receiving Androgen Deprivation Therapy for…
- Trial name
- GeniPro (NCT02766478)
- Testing
- Genistein
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Emory University
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer
This study aims to compare the efficacy and safety of rezvilutamide with enzalutamide in the treatment of patients with low-volume metastatic hormone sensitive prostate cancer.
- Trial name
- NCT07241416
- Testing
- Rezvilutamide Tablets, Enzalutamide Soft Capsules
- Where
- China
- Volunteers
- 206 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Recurrent Prostate Cancer, Stage I Prostate Cancer
Atorvastatin Calcium in Preventing Metabolic Syndrome in Prostate Cancer Patients Receiving Androgen-Deprivation Therapy
This randomized pilot clinical trial studies atorvastatin calcium in preventing metabolic syndrome in patients with prostate cancer receiving long-term androgen-deprivation therapy.
- Conditions
- Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Trial name
- NCT01555632
- Testing
- atorvastatin calcium
- Sponsor
- University of Nebraska
Oligometastatic Prostate Cancer (OMPC)
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary…
- Trial name
- PSMA-DC (NCT05939414)
- Testing
- AAA617, piflufolastat (18F), gallium (68Ga) gozetotide (25μg)
- Where
- 144 sites in United States, Argentina and 25 more
- Volunteers
- 450 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer
The study is comparing the effect on weight of providing home-delivered whole-food, plant-based meals versus standard, general nutritional counseling to men with prostate cancer on androgen-deprivation therapy (ADT).
- Trial name
- WFPBD (NCT05471414)
- Testing
- Whole-food, Plant-Based Diet, General Nutritional Counseling
- Where
- 3 sites in United States
- Volunteers
- 76 people
- Sponsor
- Weill Medical College of Cornell University