Clinical trials: Metastatic Hormone-sensitive Prostate Cancer
Prostate Cancer
CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone
This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and further define the safety of the treatment combination.
- Trial name
- NCT03934840
- Testing
- Cabazitaxel, Carboplatin, Abiraterone
- Where
- 8 sites in United States
- Volunteers
- 61 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
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
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC
The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.
- Trial name
- NCT04821622
- Testing
- talazoparib plus enzalutamide
- Where
- 312 sites in United States, Argentina and 25 more
- Volunteers
- 599 people
- Sponsor
- Pfizer
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
Prostate Cancer
The Impact of Medication Timing Adjustment on the Effect of Novel Hormonal Therapy
The purpose of this study is to assess the impact of medication timing adjustment on the effect of novel hormonal therapy (NHT) agents in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
- Trial name
- NCT06505278
- Testing
- Receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide in the evening
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Sun Yat-sen University
Metastatic Prostate Cancer
INTense ExeRcise for SurviVAL Among Men with Metastatic Prostate Cancer (INTERVAL - GAP4)
To determine if supervised high intensity aerobic and resistance training increases overall survival compared to self-directed exercise in patients with metastatic prostate cancer.
- Trial name
- INTERVAL (NCT02730338)
- Testing
- High intensity aerobic and resistance training, Psychosocial support
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 866 people
- Sponsor
- Movember Foundation
Metastatic Castration-Sensitive Prostate Cancer
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants…
- Trial name
- EvoPAR-PR01 (NCT06120491)
- Testing
- Saruparib, Abiraterone Acetate, Darolutamide
- Where
- 322 sites in United States, Australia and 22 more
- Volunteers
- 1,898 people
- Sponsor
- AstraZeneca
Prostatic Neoplasms
A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces
The purpose of this study is to learn about- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines: abiraterone, apalutamide, enzalutamide.
- Trial name
- NCT06151418
- Testing
- Novel hormonal therapy
- Where
- United States
- Volunteers
- 2,313 people
- Sponsor
- Pfizer
Prostatic Neoplasms
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-MutatedProstatic Neoplasms (mCSPC)
The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination…
- Trial name
- AMPLITUDE (NCT04497844)
- Testing
- Niraparib+ Abiraterone acetate fixed dose combination (FDC), Abiraterone acetate (AA), Prednisone
- Where
- 387 sites in United States, Argentina and 31 more
- Volunteers
- 696 people
- Sponsor
- Janssen Research & Development, LLC
Metastatic Hormone-sensitive Prostate Cancer
A Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer
Metastatic prostate cancer is an incurable disease that typically spreads beyond the prostate. The standard of care is to systemically treat the disease with androgen deprivation therapy (ADT).
- Trial name
- NCT03879122
- Testing
- Ipilimumab 5 MG/ML, Nivolumab 10 MG/ML, Docetaxel
- Where
- 30 sites in Spain
- Volunteers
- 135 people
- Sponsor
- Spanish Oncology Genito-Urinary Group
Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer
This phase I trial tests the safety and effectiveness of vudalimab (XmAb20717) in combination with standard of care treatment abiraterone, enzalutamide, or abiraterone plus docetaxel in treating patients with castration sensitive…
- Conditions
- Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Trial name
- NCT05733351
- Testing
- Abiraterone, Biospecimen Collection, Bone Scan
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Emory University
Hormone Sensitive Metastatic Prostate Cancer, DNA Damage Repair Deficiency
The Efficacy and Safety of Docetaxel Combined With Platinum for Metastatic Hormone-sensitive Prostate Cancer
This randomized controlled trial was designed to evaluate the efficacy and safety of Docetaxel combined with Platinum-based drugs compared with Docetaxel alone for metastatic hormone-sensitive prostate cancer patients carrying…
- Conditions
- Hormone Sensitive Metastatic Prostate Cancer, DNA Damage Repair Deficiency, Chemotherapy Effect, Chemotherapeutic Toxicity
- Trial name
- NCT05461261
- Testing
- Docetaxel, Prednisolone Acetate, Platinum-based drugs
- Where
- China
- Volunteers
- 50 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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
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)
This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC.
- Trial name
- NCT04191096
- Testing
- Pembrolizumab, Enzalutamide, Androgen Deprivation Therapy (ADT)
- Where
- 234 sites in United States, Australia and 27 more
- Volunteers
- 1,251 people
- Sponsor
- Merck Sharp & Dohme LLC