Clinical trials: Metastatic Hormone Sensitive Prostate Cancer, open to volunteers
Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive…
- Trial name
- NCT06334120
- Testing
- Darolutamide (Nubeqa, BAY1841788)
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Bayer
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Low-volume Metastasis
A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer
This is an observational study in which medical records of Japanese men with low-volume metastatic hormone-sensitive prostate cancer (mHSPC), who received treatment with a combination therapy of darolutamide with an androgen…
- Trial name
- HAYATE (NCT06661122)
- Testing
- Darolutamide (BAY1841788) + docetaxel + ADT
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Bayer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India
This study will follow patients with metastatic hormone-sensitive prostate cancer in India who receive darolutamide plus androgen deprivation therapy as part of routine medical care.
- Trial name
- PACE mHSPC (NCT07806591)
- Testing
- Darolutamide plus androgen deprivation therapy
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Bayer
Metastatic Hormone-Sensitive Prostate Cancer
A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice
This is an international, prospective, open-label, multicenter, multi-cohort, non-interventional observational study designed to describe the real-world effectiveness and safety of darolutamide in combination with androgen…
- Trial name
- ROAD (NCT07344779)
- Testing
- Darolutamide (BAY 1841788), ADT, Docetaxel
- Where
- 16 sites in Belgium, Finland and 14 more
- Volunteers
- 1,600 people
- Sponsor
- Bayer
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RYZ711 Diagnostic Platform Study
This is a Phase 1/2 multicenter, multi-cohort imaging study to evaluate the safety, tolerability, and diagnostic performance of RYZ711 positron emission tomography/computed tomography (PET/CT) in men with histologically confirmed…
- Conditions
- Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate, Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT07862582
- Testing
- RYZ711, PSMA PET/CT
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- RayzeBio, Inc.
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)
The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received…
- Trial name
- EvoPAR-PR05 (NCT07711002)
- Testing
- Saruparib, Enzalutamide, Darolutamide
- Where
- 210 sites in United States, Austria and 19 more
- Volunteers
- 1,330 people
- Sponsor
- AstraZeneca
Metastatic Castration Resistant Prostate Cancer, Oligometastatic Prostate Cancer (OMPC)
JUR-003 in Adult Patients With Metastatic Prostate Cancer
JUR-003-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of JUR-003 in patients with prostate cancer.
- Conditions
- Metastatic Castration Resistant Prostate Cancer, Oligometastatic Prostate Cancer (OMPC), Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT07824349
- Testing
- JUR-003
- Where
- 4 sites in United States
- Volunteers
- 210 people
- Sponsor
- Juri Biosciences, Inc.
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer
This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet…
- Conditions
- Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate
- Trial name
- NCT07028853
- Testing
- Mevrometostat, Enzalutamide
- Where
- 319 sites in United States, Argentina and 24 more
- Volunteers
- 1,000 people
- Sponsor
- Pfizer
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
This is a prospective, interventional, non-randomized, phase 2 study to assess oncologic outcomes of metastatic hormone-sensitive prostate cancer (mCSPC) patients who receive a risk-adapted treatment approach followed by…
- Trial name
- RISK-ADAPT (NCT07645326)
- Testing
- Androgen Deprivation Therapy (ADT), Androgen Receptor Pathway Inhibitor (ARPI), Prostate Radiation
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Georgetown University
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of two different treatment combinations of tulmimetostat in participants with de novo or recurrent metastatic hormone-sensitive prostate cancer…
- Trial name
- TulmiSTAR-02 (NCT07190300)
- Testing
- Tulmimetostat, Darolutamide, Abiraterone
- Where
- 31 sites in United States, Australia and 12 more
- Volunteers
- 181 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the…
- Trial name
- NCT05818683
- Testing
- Pasritamig, Cetrelimab, Cabazitaxel
- Where
- 15 sites in United States, Australia and 1 more
- Volunteers
- 300 people
- Sponsor
- Janssen Research & Development, LLC
Prostatic Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
This study aims to explore the real-world treatment adherence, persistence of apalutamide, and assess the risk of non-adherence according to the participant's profile and behavior of metastatic hormone-sensitive prostate cancer…
- Trial name
- OBSAPA (NCT07451002)
- Where
- France
- Volunteers
- 540 people
- Sponsor
- Janssen Cilag S.A.S.
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
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
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
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