Clinical trials: Metastatic Hormone Sensitive Prostate Cancer
Prostate Cancer
Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients
In this observational study, blood samples for pharmacokinetic (PK) testing will be collected from subjects with metastatic prostate cancer during their treatment with docetaxel.
- Trial name
- NCT02376296
- Testing
- docetaxel, Blood draws
- Where
- 20 sites in United States
- Volunteers
- 35 people
- Sponsor
- Saladax Biomedical, Inc.
Metastatic Hormone-sensitive Prostate Cancer, Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC)
Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer
The purpose of this study is to investigate the clinical efficacy and safety of darolutamide combined with androgen deprivation therapy (ADT) and different dose-intensity docetaxel chemotherapy in the treatment of patients with…
- Trial name
- NCT07031258
- Testing
- Dose of docetaxel
- Volunteers
- 50 people
- Sponsor
- Nanfang Hospital, Southern Medical University
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
Hormone-refractory Prostate Cancer
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
There are many treatment options for men with various stages of prostate cancer. Some treatments work well for a while but can cause medical problems in some men. Also, the cancer may come back after treatment.
- Trial name
- NCT05997615
- Testing
- VIR-5500, Androgen receptor signaling inhibitor (ARSI), Docetaxel
- Where
- 26 sites in United States, Australia and 2 more
- Volunteers
- 347 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Prostate Cancer, Intermitent Anti-androgen Therapy
Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.
- Trial name
- NCT06177015
- Testing
- Darolutamide continuous, Darolutamide intermittent
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical 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 Prostate Cancer
AI-Assisted Patient Support in mHSPC
The purpose of this multicenter, open-label, randomized controlled trial is to evaluate whether patient-centered support delivered through a large language model (LLM)-based artificial intelligence (AI) agent reduces anxiety in…
- Trial name
- LUMINOUS (NCT07804030)
- Testing
- The Same Platform without AI Agent, AI Agent-Assisted Patient-Centered Support, Delayed AI Agent-Assisted Patient-Centered Support
- Where
- 4 sites in China
- Volunteers
- 160 people
- Sponsor
- Fudan University
BRCA-Mutated, Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer
Carboplatin-Enhanced Therapy in BRCA-Mutated or Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer
The current standard of patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) is to offer androgen deprivation therapy (ADT) with androgen receptor pathway inhibitors (ARPI).
- Conditions
- BRCA-Mutated, Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer, Prostate Cancer
- Trial name
- CaBRA (NCT07591467)
- Testing
- Experimental
- Where
- 5 sites in France
- Volunteers
- 330 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Prostatic Neoplasms
Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.
- Trial name
- ARANOTE (NCT04736199)
- Testing
- Darolutamide (Nubeqa, BAY1841788), Androgen deprivation therapy (ADT)
- Where
- 131 sites in Australia, Brazil and 13 more
- Volunteers
- 669 people
- Sponsor
- Bayer
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
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
An Observational Study to Learn More About the Use of Darolutamide as a Part of a Combination Therapy in Belgian Men With Metastatic Hormone-Sensitive Prostate Cancer in Routine Medical Care
This is an observational study in which only observations from routine clinical practices will be made. Participants will not receive any advice on treatment or any changes to healthcare as a part of the study.
- Trial name
- BELBEQA (NCT06498921)
- Testing
- Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel
- Where
- Belgium
- Volunteers
- 106 people
- Sponsor
- Bayer
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
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer
LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Hormone Sensitive Prostate Cancer
This randomized phase II trial studies if enzalutamide added to standard luteinizing hormone-releasing hormone (LHRH) analogue therapy will improve effects against prostate cancer compared to the standard therapy of LHRH analogue…
- Conditions
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer
- Trial name
- NCT02058706
- Testing
- enzalutamide, bicalutamide, orchiectomy
- Where
- 4 sites in United States
- Volunteers
- 71 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
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
Prostate Cancer
Hormone Therapy With or Without Definitive Radiotherapy in Metastatic Prostate Cancer
PART I Hormone therapy with or without definitive radiotherapy in metastatic prostate cancer The goal of this clinical study PART I is to determine impact of radiotherapy treatment in combination with standard androgen…
- Trial name
- NCT02913859
- Testing
- Radiotherapy to the pelvis, Hormonal therapy (LHRH agonist and/or antiandrogens)
- Where
- Croatia
- Volunteers
- 60 people
- Sponsor
- University Hospital Sestre Milosrdnice
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)
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.
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
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