Clinical trials: Metastatic Castration-Sensitive Prostate Cancer, open to volunteers
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 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
Prostate Cancer, Stereotactic Body Radiation Therapy
START-MET HS Prostate Cancer. : SbrT & Androgen Receptor Therapy METastatic HSPC
Phase III study of stereotactic body radiation therapy (SBRT) plus standard of care in castration sensitive oligometastatic prostate cancer patients, defined as androgen deprivation therapy plus radiotherapy to the primary tumor…
- Trial name
- START-MET (NCT05209243)
- Testing
- SBRT, STANDARD OF CARE
- Where
- 2 sites in Spain
- Volunteers
- 266 people
- Sponsor
- Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
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, 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.
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 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
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
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment
Italian multicenter study, will enroll ~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide.
- Trial name
- APPROACH (NCT05649943)
- Testing
- APA + ADT, Local Treatmetn RT or RP
- Where
- 3 sites in Italy
- Volunteers
- 566 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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)
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.
Castration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone
Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
This study investigates how well radium-223 works in treating patients with castration-resistant prostate cancer than has spread to the bones (bone metastases).
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
- Trial name
- NCT04489719
- Testing
- Biospecimen Collection, Questionnaire Administration, Radium Ra 223 Dichloride
- Where
- 4 sites in United States
- Volunteers
- 48 people
- Sponsor
- University of Washington
Prostate Cancer, Hormone Sensitive Prostate Cancer
Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients
The aim of this observational study is to evaluate the clinical outcomes of treatment with docetaxel, ARTA (alone or in combination) or with radiotherapy on the primary tumor for mCSPC, in an unselected population, in clinical…
- Conditions
- Prostate Cancer, Hormone Sensitive Prostate Cancer, Metastatic Tumor
- Trial name
- ECHOS (NCT06473259)
- Testing
- Docetaxel, Apalutamide Oral Tablet, Enzalutamide Oral Tablet
- Where
- 3 sites in Italy
- Volunteers
- 3,000 people
- Sponsor
- Santa Chiara Hospital
Cancer Of Prostate, Prostate Neoplasms
A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer
Background: Metastatic castration sensitive and castration resistant prostate cancer (mCSPC and mCRPC) are prostate cancers that have spread to other parts of the body.
- Trial name
- NCT04633252
- Testing
- PDS01ADC, Docetaxel, M7824
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- National Cancer Institute (NCI)
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RYZ711 Diagnostic Platform Study
This is a Phase 1/2 multicenter, multi-cohort imaging study to evaluate the safety, tolerability, and diagnostic performance of RYZ711 positron emission tomography/computed tomography (PET/CT) in men with histologically confirmed…
- Conditions
- Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate, Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT07862582
- Testing
- RYZ711, PSMA PET/CT
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- RayzeBio, Inc.
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
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)
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 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
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.