Clinical trials: Metastatic Hormone-Sensitive Prostate Cancer
Metastatic Prostate Cancer
Talazoparib Plus Enzalutamide After Progression to Prior ARPi in Metastatic Prostate Cancer
The purpose of this clinical trial is to determine the anti-tumor activity of talazoparib plus enzalutamide as first line treatment for metastatic castration resistant prostate cancer (mCRPC) in participants whose disease has…
- Trial name
- TEAM PC (NCT06582628)
- Testing
- Enzalutamide capsule, Enzalutamide capsule and Talazoparib capsule
- Where
- 19 sites in France, Spain
- Volunteers
- 78 people
- Sponsor
- Fundacion Oncosur
Oligometastatic Hormone Sensitive Prostate Cancer
APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer
Final results from TITAN trial showed that apalutamide plus ADT improved OS in a population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if compared to ADT alone.
- Trial name
- PERSIAN (NCT05717660)
- Testing
- SBRT on all sites of metastatic disease+Apalutamide
- Where
- Italy
- Volunteers
- 180 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Prostate Cancer
A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer
This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive prostate cancer.
- Trial name
- NCT02059213
- Testing
- Ibrance, Bicalutamide, Zoladex
- Where
- 8 sites in United States
- Volunteers
- 72 people
- Sponsor
- University of Michigan Rogel Cancer Center
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
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
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)
Prostatic Neoplasms
A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
The purpose of this study is to learn about how long novel hormonal therapies are taken by men to treat mCSPC. Novel hormonal therapies in this study include study medicines abiraterone, apalutamide, and enzalutamide.
- Trial name
- NCT06072196
- Testing
- Novel hormonal therapy
- Where
- United States
- Volunteers
- 3,017 people
- Sponsor
- Pfizer
Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive…
- Trial name
- NCT06334120
- Testing
- Darolutamide (Nubeqa, BAY1841788)
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Bayer
Prostate Cancer
PSMA Response in Metastasized Hormone Sensitive Prostate Cancer
PSMA-PET/CT response measurements after LHRH agonist and upfront therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.
- Trial name
- PET-MaN (NCT05161728)
- Testing
- PSMA-PET/CT
- Where
- 4 sites in Netherlands
- Volunteers
- 150 people
- Sponsor
- Roderick van den Bergh
Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer
A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer
In this study, ASP5541 will be given to Chinese men with prostate cancer. It will be given together with prednisone and androgen deprivation therapy (ADT).
- Conditions
- Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT07339267
- Testing
- ASP5541, Prednisone
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Astellas Pharma Global Development, 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.
Metastatic Castrate Resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC
This was a multiple-center, open-label, randomized, daily dose, two-sequence, expanded/phase II study in subjects with mHSPC or mCRPC who progressed after either abiraterone or enzalutamide treatment.
- Trial name
- NCT03899467
- Testing
- GT0918
- Where
- 10 sites in United States
- Volunteers
- 61 people
- Sponsor
- Suzhou Kintor Pharmaceutical Inc,
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
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.
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 Prostate Cancer, Castration-Sensitive Prostate Cancer
Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment
To assess the feasibility and safety of Maximal cytoreductive therapies in patients with de novo mCSPC who achieve ≤10 oligopersistent metastases on PSMA PET CT after initial 3-month systemic treatment with apalutamide plus ADT.
- Trial name
- CHAMPION (NCT05717582)
- Testing
- apalutamide, androgen deprivation therapy, cytoreductive radical prostatectomy with/without pelvic lymph node dissection
- Where
- 2 sites in China
- Volunteers
- 47 people
- Sponsor
- Fudan University
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
Enzalutamide Plus Talazoparib for the Treatment of Hormone Sensitive Prostate Cancer (ZZ-First)
This is a multicenter, open-label, randomized, two-arm, phase II clinical trial to evaluate the efficacy and safety of talazoparib (PF-06944076) in combination with enzalutamide in patients with metastatic hormone-naïve prostate…
- Trial name
- ZZ-First (NCT04332744)
- Testing
- Enzalutamide, Talazoparib
- Where
- 8 sites in Spain
- Volunteers
- 54 people
- Sponsor
- MedSIR
Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
Survey Based Discrete Choice Experiment Study in Prostate Cancer (DECIDER) Study
The purpose of this study is to quantify and publish participants' relative preferences for outcomes of chemotherapy and novel oral hormonal agents when added to androgen deprivation therapy (ADT) for participants with…
- Trial name
- NCT05381311
- Where
- United States
- Volunteers
- 1,020 people
- Sponsor
- Astellas Pharma Global Development, 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