Clinical trials: Metastatic Hormone Sensitive Prostate Cancer
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
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
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
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany
Prostate cancer is a disease where cells in the prostate gland grow out of control. When prostate cancer has spread to other parts of the body but still responds to hormone treatment, it is called metastatic hormone-sensitive…
- Trial name
- 23146 (NCT07395804)
- Testing
- darolutamide plus ADT treatment
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Bayer
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.
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Deleterious HRR Gene Mutation
Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
This is an open label, phase II trial in subjects with treatment naïve, metastatic hormone sensitive prostate cancer (mHSPC) with deleterious homologous recombination repair (HRR) alteration(s).
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Deleterious HRR Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation
- Trial name
- HARMONY (NCT06392841)
- Testing
- Androgen Deprivation Therapy (ADT), Niraparib/Abiraterone Acetate DAT, Abiraterone Acetate
- Sponsor
- Qian Qin
Metastatic Hormone-Sensitive Prostate Cancer, Prostate Cancer
PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.
This multicenter retrospective study developed and validated a prediction model based on PSMA PET/CT and routine clinical information to estimate early treatment response in patients with metastatic hormone-sensitive prostate…
- Trial name
- NCT07428642
- Testing
- Androgen Deprivation Therapy, Apalutamide, Enzalutamide
- Where
- China
- Volunteers
- 168 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
Prostate Cancer, Biochemical Recurrence of Malignant Neoplasm of Prostate
PROCARE - PROstate Cancer Real World Evidence Registry
The aim of this registry study with long-term follow-up is to record the course of therapy and disease in patients with recurrent and metastatic prostate cancer.
- Conditions
- Prostate Cancer, Biochemical Recurrence of Malignant Neoplasm of Prostate, Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Trial name
- PROCARE (NCT06835218)
- Where
- 53 sites in Germany
- Volunteers
- 5,000 people
- Sponsor
- UroTrials Company (GmbH)