Clinical trials: Metastatic Hormone Sensitive Prostate Cancer, active
Metastatic Castrate-sensitive Prostate Cancer
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level…
- Trial name
- LIBERTAS (NCT05884398)
- Testing
- Apalutamide, Androgen-deprivation Therapy (ADT)
- Where
- 93 sites in United States, Australia and 7 more
- Volunteers
- 420 people
- Sponsor
- Janssen Research & Development, LLC
Prostate Cancer
The Case of "Triple" Versus "Double" Therapy for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer
Lead4Care is an observational, open-label, multicenter study evaluating the effectiveness, tolerance, and cost-effectiveness of triple against double therapy in matched groups of mHSPC patients with high tumor burden.
- Trial name
- Lead4Care (NCT06446401)
- Testing
- ADT + NHT + Docetaxel, ADT + NHT
- Where
- 2 sites in Sweden
- Volunteers
- 1,400 people
- Sponsor
- Uppsala University
Prostate Cancer
CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer
The goal of this clinical trial is to compare systemic therapy combined with cytoreductive prostatectomy with standard of care (SOC) in de novo poly-metastatic hormone sensitive prostate cancer (de novo pmHSPC).
- Trial name
- CREATIVE (NCT06306612)
- Testing
- Systemic Chemohormonal Therapy, Systemic Hormonal Therapy, Cytoreductive Prostatectomy
- Where
- China
- Volunteers
- 192 people
- Sponsor
- RenJi Hospital
Prostate Cancer (Adenocarcinoma)
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs? This study would like to find out if this approach…
- Trial name
- TRIPLE-SWITCH (NCT06592924)
- Testing
- Abiraterone, Enzalutamide, Apalutamide
- Where
- 395 sites in United States, Canada and 2 more
- Volunteers
- 830 people
- Sponsor
- Canadian Cancer Trials Group
Cancer, Urology
Monitoring Treatment Response With Urine and Serum Metabolome Markers in Patients Treated With Novel Hormone Therapy and Have Either Hormone Sensitive Metastatic Prostate Cancer or Disease Progression on Treatment.
80% of patients with newly diagnosed metastatic hormone sensitive prostate cancer have bone metastases. There are mutations that are described with early disease progression when on hormone therapy for prostate cancer.
- Trial name
- Metabolome-PC (NCT07837063)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
Prostate Cancer
Study on Triple Therapy Combined With HIFU for High-Tumor-Burden mHSPC
This study is a single-arm prospective cohort study designed to evaluate the efficacy and safety of triple therapy (ADT + darolutamide + docetaxel) combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy…
- Trial name
- NCT07172685
- Testing
- Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Qilu Hospital of Shandong University
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
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
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
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
Castrate Sensitive Prostate Cancer, Metastatic Prostate Cancer
Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)
This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B).
- Trial name
- NCT06429813
- Testing
- Home-Based Exercise Intervention - Walking, Home-Based Exercise Intervention - HIIT Cycling
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Paul Viscuse
Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer
Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC
Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the…
- Conditions
- Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer, Chemotherapy Effect
- Trial name
- NCT05983783
- Testing
- Docetaxel, Rezvilutamide
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Prostate Adenocarcinoma
Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
This phase 2 trial studies radium Ra 223 dichloride, hormone therapy and stereotactic body radiation in treating patients with prostate cancer that has spread to other places in the body.
- Trial name
- NCT03361735
- Testing
- Leuprolide Acetate, Goserelin Acetate, Stereotactic Body Radiation Therapy
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- City of Hope Medical Center
Oligoprogressive Prostate Cancer, Metastatic Prostate Cancer
PSMA PET-Staged Comprehensive Progression-Directed Radiotherapy for Limited Progression in Prostate Cancer
PSMA-OLIGO-PRO is a multicenter, ambispective, observational real-world evidence registry of adults with metastatic hormone-sensitive or metastatic castration-resistant prostate cancer who develop a limited number of progressing…
- Trial name
- PSMA-OLIGO-PRO (NCT07691697)
- Testing
- Comprehensive Progression-Directed Radiotherapy
- Where
- Poland
- Volunteers
- 1,000 people
- Sponsor
- Affidea Nu-med Center of Oncological DIagnostics and Therapy
Prostatic Neoplasms, Neoplasm Metastasis
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
- Conditions
- Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms, Physiological Effects of Drugs
- Trial name
- CYCLONE 3 (NCT05288166)
- Testing
- Abemaciclib, Abiraterone, Prednisone or Prednisolone
- Where
- 266 sites in United States, Argentina and 22 more
- Volunteers
- 925 people
- Sponsor
- Eli Lilly and Company
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer
ACCEL is a multicenter, open label phase Ia/Ib/II study of [Ac-225]-PSMA-62 in participants with prostate-specific membrane antigen (PSMA)-positive prostate cancer.
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Oligometastatic Prostate Carcinoma, Hormone Sensitive Prostate Cancer
- Trial name
- ACCEL (NCT06229366)
- Testing
- [Ac-225]-PSMA-62 (mCRPC), [Ac-225]-PSMA-62 (OmHSPC)
- Where
- 7 sites in Canada
- Volunteers
- 142 people
- Sponsor
- Eli Lilly and Company
Metastatic Hormone-sensitive Prostate Cancer
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor…
- Trial name
- NCT06991556
- Testing
- JSB462, Abiraterone, Enzalutamide
- Where
- 65 sites in United States, Australia and 13 more
- Volunteers
- 168 people
- Sponsor
- Novartis Pharmaceuticals
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, Metastatic Castration Resistant Prostate Cancer
A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
Medicines that reduce the amount of testosterone in the body are commonly used to treat prostate cancer. PRL-02 depot is a potential treatment for men with advanced prostate cancer. It is given by an injection into the muscle.
- Conditions
- Prostate Cancer, Metastatic Castration Resistant Prostate Cancer, Metastatic Castration-sensitive Prostate Cancer
- Trial name
- NCT04729114
- Testing
- PRL-02 injection, prednisone, dexamethasone
- Where
- 25 sites in United States, Puerto Rico
- Volunteers
- 174 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Hormone Sensitive Prostate Cancer
An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
The purpose of this study was to evaluate the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in Chinese subjects with metastatic hormone sensitive prostate cancer (mHSPC).
- Trial name
- China ARCHES (NCT04076059)
- Testing
- Enzalutamide, Androgen deprivation therapy (ADT)
- Where
- 28 sites in China
- Volunteers
- 180 people
- Sponsor
- Astellas (Beijing) Pharmaceutical R&D Co., Ltd.