Clinical trials: Hormone-Sensitive Prostate Cancer
Metastatic Prostate Cancer, Prostate Cancer Metastatic
Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide
This is a prospective, randomized, open-label phase II study comparing cognitive outcomes between men with metastatic and non-metastatic castration resistant prostate cancer (CRPC) or metastatic hormone sensitive prostate cancer…
- Conditions
- Metastatic Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer, Castrate Resistant Prostate Cancer
- Trial name
- ARACOG (NCT04335682)
- Testing
- Darolutamide, Enzalutamide
- Where
- 8 sites in United States
- Volunteers
- 111 people
- Sponsor
- Alliance Foundation Trials, LLC.
Recurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial
This phase II trial tests leuprolide acetate alone versus in combination with 177Lu-PSMA-617, with or without abiraterone acetate and prednisone, for the treatment of hormone-sensitive prostate cancer has spread to a limited…
- Conditions
- Recurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8, Castration-Sensitive Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Trial name
- SPARKLE (NCT07650240)
- Testing
- Abiraterone Acetate, Biospecimen Collection, Leuprolide Acetate
- Where
- United States
- Volunteers
- 202 people
- Sponsor
- Mayo Clinic
Metastatic Hormone-sensitive Prostate Cancer
A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.
The purpose of the study is to assess if the addition of darolutamide to ADT compared with ADT alone would result in superior clinical efficacy in participants with metastatic hormone-sensitive prostate cancer (mHSPC) by…
- Trial name
- ARASEC (NCT05059236)
- Testing
- Darolutamide (BAY1841788, Nubeqa), ADT
- Where
- 31 sites in United States
- Volunteers
- 223 people
- Sponsor
- Bayer
Hormone-Sensitive Prostate Cancer
Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in…
- Trial name
- CAPItello-281 (NCT04493853)
- Testing
- Capivasertib, Abiraterone Acetate
- Where
- 323 sites in United States, Argentina and 30 more
- Volunteers
- 1,012 people
- Sponsor
- AstraZeneca
High Risk Localized Prostate Cancer, Synchronous Metastatic Hormone-Sensitive Prostate Cancer
Prospective Prostate Cancer Infrastructure
The goal of this observational study is to collect detailed long-term real-world data and biomaterials from men with high-risk localized prostate cancer and synchronous metastatic hormone-sensitive prostate cancer.
- Trial name
- ProPCI (NCT07560748)
- Where
- Netherlands
- Volunteers
- 700 people
- Sponsor
- Radboud University Medical Center
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC
This is a multicenter, randomized, open-label phase 2 study for men with metastatic hormone-sensitive prostate cancer. About 254 participants will first receive 6 months of darolutamide plus androgen deprivation therapy.
- Trial name
- PSMA-DaroRT (NCT07649421)
- Testing
- Stereotactic Body Radiotherapy (SBRT), Darolutamide 600 mg twice daily, Androgen Deprivation Therapy (ADT)
- Where
- China
- Volunteers
- 254 people
- Sponsor
- West China Hospital
Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body.
- Conditions
- Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT07005154
- Testing
- ASP5541, Prednisone, Prednisolone
- Where
- 54 sites in United States, China and 10 more
- Volunteers
- 218 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Hormone-Sensitive Prostate Cancer
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)-China Extension
This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in Chinese participants with mHSPC.
- Trial name
- NCT04934722
- Testing
- Pembrolizumab, Enzalutamide, Androgen Deprivation Therapy (ADT)
- Where
- 24 sites in China
- Volunteers
- 186 people
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Hormone-Sensitive Prostate Cancer
A Prospective Study Based on Spatial Multi-omics to Predict the Efficacy of ADT Combined With Second-generation Novel Hormonal Agents in Metastatic Hormone-sensitive Prostate Cancer.
This study plans to enroll patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) and conduct a prospective, single-center, observational study.
- Trial name
- NCT07795177
- Testing
- ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide)
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Anhui Medical University
Oligometastatic Hormone-Sensitive Prostate Cancer, Prostate Adenocarcinoma
Prospective Study on the Role of Radical Prostatectomy in Oligo-metastatic Hormone-sensitive Prostate Cancer in Patients on Androgen Deprivation Therapy
MAZINGA is a prospective, single-group pilot study evaluating disease control after robot-assisted radical prostatectomy with extended pelvic lymph-node dissection in men with oligometastatic hormone-sensitive prostate…
- Trial name
- MAZINGA (NCT07766486)
- Testing
- Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Fondazione del Piemonte per l'Oncologia
Hormone Sensitive Prostate Cancer, Prostate Adenocarcinoma
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors
This research study is studying a combination of hormonal therapy, chemotherapy, and immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer.
- Conditions
- Hormone Sensitive Prostate Cancer, Prostate Adenocarcinoma, Metastasis Prostate Adenocarcinoma
- Trial name
- NCT04126070
- Testing
- Androgen Deprivation Therapy, Nivolumab, Docetaxel
- Where
- 6 sites in United States
- Volunteers
- 47 people
- Sponsor
- Xiao X. Wei, MD
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients
The purpose of this clinical phase 3 randomized trial is to compare two different dosing schedules of Docetaxel in combination with ADT and Darolutamide in subjects with mHSPC.
- Trial name
- ARASAFE (NCT05676203)
- Testing
- Standard ADT (androgen deprivation therapy), Standard Darolutamide, Docetaxel
- Where
- 43 sites in Austria, Germany
- Volunteers
- 250 people
- Sponsor
- Jena University Hospital
Metastatic Hormone-sensitive Prostate Cancer
A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
The purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate…
- Trial name
- ArtemisPRO (NCT05901649)
- Testing
- Apalutamide, Enzalutamide
- Where
- 53 sites in Austria, France and 4 more
- Volunteers
- 505 people
- Sponsor
- Janssen-Cilag Ltd.
Metastatic Hormone-Sensitive Prostate Cance
Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer
GUARD-QUANTUM is a prospective, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study. The rationale behind studying this combination lies in the potential additive or synergistic benefits that may arise…
- Trial name
- GUARD-QUANTUM (NCT07717099)
- Testing
- Ra223, Darolutamide Oral Tablet, Androgen Deprivation Therapy (ADT)
- Where
- 12 sites in Spain
- Volunteers
- 50 people
- Sponsor
- Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
Prostatic Neoplasms, Metastatic Hormone-Sensitive Prostate Cancer
A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics
Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive…
- Trial name
- Double-DARE (NCT07406282)
- Testing
- Darolutamide, Abiraterone acetate, Enzalutamide
- Where
- United States
- Volunteers
- 1,400 people
- Sponsor
- Bayer
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
- Trial name
- NCT07140900
- Testing
- Xaluritamig, Darolutamide, Abiraterone
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 60 people
- Sponsor
- Amgen
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
The purpose of this study is to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.
- Trial name
- OPTIMAS (NCT07216248)
- Testing
- relugolix + ARPI, Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI, relugolix or androgen deprivation therapy (ADT) + ARPI
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- University of Utah
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer
This is an observational study in which only data are collected from participants receiving their usual treatment. In this study, data will be collected and studied from men with metastatic hormone-sensitive prostate cancer…
- Trial name
- DADOX (NCT06010914)
- Testing
- No Intervention
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Bayer
Metastatic Hormone-sensitive Prostate Cancer
Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.
This is a phase III, randomized, open-label, multi-center study to assess the efficacy of treatment intensification with docetaxel plus apalutamide and ADT, assessed by event-free survival, in patients with mHSPC who do not…
- Trial name
- REINFORCE (NCT07333066)
- Testing
- Apalutamide (Erleada™) 60 mg or 240 mg tablets, Docetaxel
- Where
- 56 sites in France, Germany and 3 more
- Volunteers
- 320 people
- Sponsor
- Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
Prostate Cancer, Prostate Adenocarcinoma
PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
The purpose of this prostate cancer research study is to learn about: 1. Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen…
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Hormone Sensitive Prostate Cancer
- Trial name
- OCEAN (NCT06392295)
- Testing
- Para Aortic Radiation Therapy: Photon Therapy, Para Aortic Radiation Therapy: Proton Therapy, Androgen Deprivation Therapy
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- University of Miami