Clinical trials: Metastatic Castration-Sensitive Prostate Cancer
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
Aggressive Disease Treatment Patterns and CtDNA HRR evaluatiON in High-volume metastatiC hORmone-sensitive Prostate Cancer in Russian FeDeration
A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation
- Trial name
- CONCORD (NCT07052578)
- Where
- 28 sites in Russia
- Volunteers
- 230 people
- Sponsor
- AstraZeneca
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
An Observational Study to Learn More About Treatment Patterns and Factors Determining the Choice of Treatment in Canadian Men With Metastatic Hormone Sensitive Prostate Cancer in Routine Medical Care
This is an observational study in which only data are collected from adult Canadian men with metastatic hormone sensitive prostate cancer (mHSPC) are studied.
- Trial name
- RE-ENGAGE (NCT06874114)
- Where
- Canada
- Volunteers
- 477 people
- Sponsor
- Bayer
Prostate Cancer
Diagnostic and Prognostic Accuracy of FDHT-PET and Liquid Biopsies in Prostate Cancer
Depending on the cohort of the study the diagnostic and prognostic accuracy and health economics considerations of [18F]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET) and/or circulating tumor cells in…
- Trial name
- NCT05245435
- Testing
- FDHT-PET Scan, liquid biopsies
- Where
- Austria
- Sponsor
- Medical University of Vienna
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
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.
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
Prostate Cancer
Expression of Tumor Markers in Circulating Tumor Cells of Metastatic Hormone-sensitive Prostate Cancer
As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments.
- Trial name
- NCT02723526
- Testing
- Blood drawing
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Fudan University
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer
This prospective observational study will evaluate quality of life, functional status, and cognitive outcomes in men with metastatic hormone-sensitive prostate cancer (mHSPC) receiving androgen receptor pathway inhibitors (ARPIs)…
- Trial name
- PRO-MIND (NCT07181122)
- Testing
- Androgen Receptor Pathway Inhibitors (ARPIs)
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 230 people
- Sponsor
- Ankara Etlik City Hospital
Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer
Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week…
- Conditions
- Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer
- Trial name
- NCT04666129
- Testing
- Relugolix, Abiraterone, Prednisone
- Where
- 16 sites in United States
- Volunteers
- 48 people
- Sponsor
- Sumitomo Pharma America, Inc.
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.
Prostate Cancer
Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone
This is a phase II, randomized, open label study comparing first line therapy with AThis is a phase II, randomized, open label study comparing first line therapy with ADT + abiraterone (doublet arm) or ADT + abiraterone +…
- Trial name
- NCT06060587
- Testing
- Docetaxel, ADT, Abiraterone
- Where
- United States
- Sponsor
- Northwestern University
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
Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer
PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer
The goal of this clinical trial is to learn if serial PSMA-PET/CT scans can be used to monitor response to therapy in metastatic hormone sensitive prostate cancer and can be potentially used to optimize future treatment…
- Conditions
- Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT06479187
- Testing
- 18F-rhPSMA-7.3, PET/CT
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Brigham and Women's Hospital
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
Metastatic Castration Sensitive Prostate Cancer
Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
This is a prospective single center phase IIa open label nonrandomized study, which aims to test the hypothesis that the duration of castration sensitive phase of stage IV prostate cancer can be prolonged with adaptive androgen…
- Trial name
- NCT06734130
- Testing
- Luteinizing Hormone-Releasing Hormone (LHRH) analog, Androgen Receptor Signal Inhibitor (ARSI), Docetaxel
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
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
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
This phase II trial studies if talazoparib works in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and has mutation(s) in…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Clinical Stage III Gastric Cancer AJCC v8
- Trial name
- NCT04550494
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- National Cancer Institute (NCI)
Prostate Cancer
Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.
This prospective clinical trial aims to investigate the impact of darolutamide in combination with standard-of-care androgen deprivation on physical activity, specifically step count, and its correlation with important markers of…
- Trial name
- NCT06660862
- Testing
- Darolutamide, Physician choice Androgen Deprivation (Hormone) Therapy
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Chicago