Clinical trials: Metastatic Hormone-sensitive Prostate Cancer
- Condition Metastatic Hormone-sensitive Prostate Cancer
- Funder type Industry (pharma, biotech, devices)
Metastatic Hormone-sensitive Prostate Cancer
An Observational Study to Learn More About the Use of Darolutamide as a Part of a Combination Therapy in Belgian Men With Metastatic Hormone-Sensitive Prostate Cancer in Routine Medical Care
This is an observational study in which only observations from routine clinical practices will be made. Participants will not receive any advice on treatment or any changes to healthcare as a part of the study.
- Trial name
- BELBEQA (NCT06498921)
- Testing
- Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel
- Where
- Belgium
- Volunteers
- 106 people
- Sponsor
- Bayer
Metastatic Castration Resistant Prostate Cancer
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Himalayas-1 is a randomized, open-label, global, multicenter phase 3 study evaluating whether the combination of rinzimetostat with darolutamide is more effective compared to physician's choice of control; ARPI (darolutamide or…
- Trial name
- Himalayas-1 (NCT07723248)
- Testing
- Rinzimetostat, Darolutamide, Enzalutamide
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 600 people
- Sponsor
- ORIC Pharmaceuticals
Metastatic Castration Resistant Prostate Cancer, Oligometastatic Prostate Cancer (OMPC)
JUR-003 in Adult Patients With Metastatic Prostate Cancer
JUR-003-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of JUR-003 in patients with prostate cancer.
- Conditions
- Metastatic Castration Resistant Prostate Cancer, Oligometastatic Prostate Cancer (OMPC), Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT07824349
- Testing
- JUR-003
- Where
- 4 sites in United States
- Volunteers
- 210 people
- Sponsor
- Juri Biosciences, Inc.
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 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 Hormone-sensitive Prostate Cancer (mHSPC)
A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer
This is an observational study in which only data are collected from participants receiving their usual treatment. In this study, data will be collected and studied from men with metastatic hormone-sensitive prostate cancer…
- Trial name
- DADOX (NCT06010914)
- Testing
- No Intervention
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Bayer
Metastatic Hormone-Sensitive Prostate Cancer
Non-Interventional Study to Establish Consensus on Management of Metastatic Hormone-Sensitive Prostate Cancer Patients
The purpose of this study is to establish an expert consensus recommendations on managing patients with mHSPC in South Korea, and to provide clinicians with a comprehensive guide to support their clinical decision making.
- Trial name
- NCT06452212
- Testing
- No Intervention
- Where
- South Korea
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Korea, Inc.
Prostate Cancer, High-risk Biochemical Recurrence
Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer
The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).
- Conditions
- Prostate Cancer, High-risk Biochemical Recurrence, High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer, Non-metastatic Castration-sensitive Prostate Cancer
- Trial name
- NCT06555796
- Testing
- Xaluritamig
- Where
- 11 sites in United States, Australia
- Volunteers
- 50 people
- Sponsor
- Amgen
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)
The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received…
- Trial name
- EvoPAR-PR05 (NCT07711002)
- Testing
- Saruparib, Enzalutamide, Darolutamide
- Where
- 210 sites in United States, Austria and 19 more
- Volunteers
- 1,330 people
- Sponsor
- AstraZeneca
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Metastatic Castration Resistant Prostate Cancer (mCRPC)
Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland
Comprehensive understanding of the epidemiology and disease burden of metastatic prostate cancer patients in Finland is lacking.
- Trial name
- NCT05701007
- Testing
- abiraterone, enzalutamide, docetaxel
- Where
- Finland
- Volunteers
- 1,083 people
- Sponsor
- Pfizer
Metastatic Castration Sensitive Prostate Cancer (mCSPC)
A Study to Learn About the Outcomes Between Study Medicines, Enzalutamide and Darolutamide Among Men With Metastatic Castration Sensitive Prostate Cancer (mCSPC)
The purpose of this real-world study of electronic medical records is to look back to compare the time to next treatment after initial treatment with enzalutamide or darolutamide in addition to androgen deprivation therapy (ADT).
- Trial name
- NCT07779590
- Testing
- darolutamide plus androgen deprivation therapy, Enzalutamide plus androgen deprivation therapy
- Where
- United States
- Volunteers
- 4,700 people
- Sponsor
- Pfizer
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.
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
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
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
This is a prospective, open-label, dose-escalation and randomized dose optimization and expansion study. The Phase Ib portion of the study aims to determine the safety and tolerability of escalating doses of [212Pb]Pb-ADVC001…
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT05720130
- Testing
- [²¹²Pb]Pb-ADVC001 (Phase 1b), [²¹²Pb]Pb-ADVC001 (Phase 2a)
- Where
- 3 sites in Australia
- Volunteers
- 100 people
- Sponsor
- AdvanCell Pty Limited
Prostate Cancer
Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis
The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when…
- Trial name
- NCT00035997
- Testing
- Zometa
- Where
- 56 sites in United States
- Volunteers
- 261 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Neoplasms, Neoplasm Metastasis
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
- Conditions
- Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms, Physiological Effects of Drugs
- Trial name
- CYCLONE 3 (NCT05288166)
- Testing
- Abemaciclib, Abiraterone, Prednisone or Prednisolone
- Where
- 266 sites in United States, Argentina and 22 more
- Volunteers
- 925 people
- Sponsor
- Eli Lilly and Company
Metastatic Cancer, Neoplasm, Prostate
Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC.
- Conditions
- Metastatic Cancer, Neoplasm, Prostate, Castrate-sensitive, Castrate-sensitive Prostate Cancer
- Trial name
- NCT05422911
- Testing
- Abiraterone acetate, Apalutamide, Enzalutamide
- Where
- 12 sites in United States
- Volunteers
- 192 people
- Sponsor
- Sun Pharmaceutical Industries Limited
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.
Prostate Cancer
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC
The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.
- Trial name
- NCT04821622
- Testing
- talazoparib plus enzalutamide
- Where
- 312 sites in United States, Argentina and 25 more
- Volunteers
- 599 people
- Sponsor
- Pfizer