Clinical trials: Hormone-Sensitive Prostate Cancer
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
Prostate Adenocarcinoma, Recurrent Prostate Carcinoma
Itraconazole in Treating Patients With Biochemically Relapsed Prostate Cancer
This phase II trial studies how well itraconazole works in treating patients with biochemically relapsed prostate cancer. Itraconazole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Conditions
- Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage I Prostate Adenocarcinoma AJCC v7, Stage II Prostate Adenocarcinoma AJCC v7
- Trial name
- NCT01787331
- Testing
- Itraconazole, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of California, San Francisco
Prostate Cancer
Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases
The present study will give information about the course over time in skeletal-related events (SRE) in prostate cancer patients with bone metastases treated with zoledronic acid 4 mg administered as a 15-minute infusion every 4…
- Trial name
- NCT00219219
- Testing
- Zoledronic acid
- Where
- Italy
- Sponsor
- Novartis
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Cancer of the Prostate
A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC)
The purpose of this study is to learn about how long apalutamide and enzalutamide are taken by men to treat mCSPC. Prostate cancer is one of the most common cancers in men.
- Conditions
- Metastatic Castration Sensitive Prostate Cancer (mCSPC), Cancer of the Prostate, Prostate Neoplasms, Prostate Cancer
- Trial name
- NCT07086651
- Testing
- Enzalutamide, Apalutamide
- Where
- United States
- Volunteers
- 1,300 people
- Sponsor
- Pfizer
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer
This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet…
- Conditions
- Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate
- Trial name
- NCT07028853
- Testing
- Mevrometostat, Enzalutamide
- Where
- 319 sites in United States, Argentina and 24 more
- Volunteers
- 1,000 people
- Sponsor
- Pfizer
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 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-sensitive Prostate Cancer
Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan
To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment
- Trial name
- CUARTET (NCT04601441)
- Testing
- Apalutamide
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Kindai University
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 in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive…
- Trial name
- ARASENS (NCT02799602)
- Testing
- BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel
- Where
- 322 sites in United States, Australia and 21 more
- Volunteers
- 1,306 people
- Sponsor
- Bayer
Hormone-Sensitive Prostate Cancer
Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in…
- Trial name
- CAPItello-281 (NCT04493853)
- Testing
- Capivasertib, Abiraterone Acetate
- Where
- 323 sites in United States, Argentina and 30 more
- Volunteers
- 1,012 people
- Sponsor
- AstraZeneca