Clinical trials: Castrate Sensitive Prostate Cancer, open to volunteers
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
Castration Sensitive Prostate Cancer, Metastatic Prostate Cancer
A Study Testing if Patients With Advanced Prostate Cancer Who Are Responding Well to Combination Treatment Can Safely Reduce Their Medication to a Single Hormone Therapy, Compared to Continuing Their Current Drugs
The goal of this randomized comparative study (a study where participants are placed into groups by chance) is to find out if reducing treatment to androgen deprivation therapy (ADT)-a treatment that lowers testosterone-by itself…
- Trial name
- STEPDOWNmHSPC (NCT07838753)
- Testing
- De-escalation strategy, Continuation of initial Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) combination therapy at standard doses
- Where
- India
- Volunteers
- 170 people
- Sponsor
- Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
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
Prostate Cancer, Metastatic Cancer
PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer
Prostate cancer remains the most common malignancy in men in Europe. Over the last two decades, the treatment landscape for both localized and metastatic prostate cancer has been revolutionized.
- Conditions
- Prostate Cancer, Metastatic Cancer, Castrate Sensitive Prostate Cancer
- Trial name
- PSA-DEEP02 (NCT06652607)
- Testing
- Enzalutamide, Apalutamide (Erleada™) 60 mg or 240 mg tablets, Darolutamide (Nubeqa®) 300 mg tablets
- Where
- Italy
- Volunteers
- 152 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Advanced Solid Tumors
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.
- Trial name
- NCT05914116
- Testing
- DB-1311, Lopinavir and Ritonavir Tablets, itraconazole
- Where
- 107 sites in United States, Australia and 2 more
- Volunteers
- 862 people
- Sponsor
- DualityBio Inc.
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC
Primary Objective: To explore whether a 6-month course of Rezvilutamide in the triple therapy regimen is non-inferior to long-term Rezvilutamide treatment in improving radiographic progression-free survival (rPFS) in patients…
- Trial name
- NCT05956639
- Testing
- 6-month course of antiandrogen drugs, Long-term course of antiandrogen drugs
- Where
- China
- Volunteers
- 100 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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
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
Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
PEACE-6 Poor Responders is an international, multicenter, open-label, controlled, randomized, phase III trial to evaluate the efficacy and safety of 177Lu-PSMA-617 when administered on top of the ongoing standard systemic…
- Trial name
- NCT06496581
- Testing
- 177Lu-PMSA-617, Standard of Care
- Where
- 25 sites in France
- Volunteers
- 500 people
- Sponsor
- UNICANCER
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
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.
Prostate Cancer Metastatic, Radiation Therapy
Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer
The study is an open label, multi-centre, randomized phase III study. The patients will be randomised in a 1:1 ratio to treatment consisting of Arm A: MD-SBRT in addition to standard treatment Arm B: Standard treatment Study…
- Conditions
- Prostate Cancer Metastatic, Radiation Therapy, Positron-Emission Tomography
- Trial name
- METRO (NCT04983095)
- Testing
- stereotactic body radiotherapy, androgen deprivation therapy, Radiotherapy
- Where
- 7 sites in Sweden
- Volunteers
- 118 people
- Sponsor
- Karin Soderkvist
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)
Testosterone-Informed De-Escalation in Metastatic Prostate Cancer (TIDE PC)
The purpose of this study is to use androgen deprivation therapy (ADT) intermittently in hopes of reducing side effects from ADT and reducing unnecessary dosing of ADT in adult men with a prolonged response to frontline therapy…
- Trial name
- NCT07904026
- Testing
- Androgen Deprivation Therapy (ADT), Androgen Receptor Pathway Inhibitors (ARPIs)
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University of Nebraska
Prostate Cancer Metastatic
A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer
STAMPEDE2 is a clinical trial comparing two new treatments with standard of care in people with prostate cancer that has spread to other parts of the body and is responsive to hormone therapy.
- Trial name
- STAMPEDE2 (NCT06320067)
- Testing
- Stereotactic Ablative Body Radiotherapy (SABR), 177Lu-PSMA-617, Androgen Deprivation Therapy (ADT)
- Where
- 18 sites in United Kingdom
- Volunteers
- 3,360 people
- Sponsor
- University College, London
Castration Sensitive Prostate Cancer
A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy
The goal of this clinical trial is to assess the feasibility of adding a combination of metformin and turmeric as part of a nutritional intervention regimen to the current standard of care, namely, intermittent Androgen…
- Trial name
- NCT06044025
- Testing
- Metformin, Turmeric
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- University of Arkansas