Clinical trials: Hormone Sensitive Prostate Cancer, open to volunteers
Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
ProBio is an international, outcome-adaptive, multi-arm, open-label, multiple assignment randomized biomarker driven platform trial in patients with metastatic prostate cancer.
- Trial name
- ProBio (NCT03903835)
- Testing
- Enzalutamide Oral Capsule, Abiraterone Oral Tablet, Carboplatin
- Where
- 32 sites in Belgium, Norway and 2 more
- Volunteers
- 750 people
- Sponsor
- Karolinska Institutet
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India
This study will follow patients with metastatic hormone-sensitive prostate cancer in India who receive darolutamide plus androgen deprivation therapy as part of routine medical care.
- Trial name
- PACE mHSPC (NCT07806591)
- Testing
- Darolutamide plus androgen deprivation therapy
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Bayer
Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started…
- Conditions
- Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Trial name
- NCT06931340
- Testing
- Androgen Therapy, Apalutamide, Docetaxel
- Where
- 214 sites in United States
- Volunteers
- 1,260 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Castration-Sensitive Prostate Adenocarcinoma, Metastatic Castration-Sensitive Prostate Adenocarcinoma
Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial
This phase II trial compares giving estrogen with an androgen receptor signaling inhibitor to standard of care luteinizing hormone-releasing hormone (LHRH) analogues with an androgen receptor signaling inhibitor for improving…
- Conditions
- Castration-Sensitive Prostate Adenocarcinoma, Metastatic Castration-Sensitive Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Trial name
- NCT07466498
- Testing
- Androgen Receptor Pathway Inhibitor, Transdermal Estrogen, Bone Scan
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Fred Hutchinson Cancer Center
Prostate Cancer
Apa/Enza-short Study: Shorter Treatment With Androgen Receptor Pathway Inhibitor in Patients With Low-volume Metastatic Castration-sensitive Prostate Cancer
The goal of this clinical trial is to evaluate the outcomes of a shorter treatment duration (12 months) with an androgen receptor pathway inhibitor (ARPI), in this study Apalutamide or Enzalutamide, in patients with low-volume…
- Trial name
- Apa/Enza-short (NCT07260435)
- Testing
- ADT plus only 12 months of ARPI, ADT plus continued ARPI
- Where
- 26 sites in Netherlands
- Volunteers
- 400 people
- Sponsor
- Nick Beije
Metastatic Hormone-Sensitive Prostate Cancer
A Prospective Study Based on Spatial Multi-omics to Predict the Efficacy of ADT Combined With Second-generation Novel Hormonal Agents in Metastatic Hormone-sensitive Prostate Cancer.
This study plans to enroll patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) and conduct a prospective, single-center, observational study.
- Trial name
- NCT07795177
- Testing
- ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide)
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Anhui Medical University
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 Prostate Cancer
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.
- Trial name
- NCT06800313
- Testing
- JNJ-101556143 Formulation 1, JNJ-101556143 Formulation 2, JNJ-101556143 Formulation 3
- Where
- 18 sites in United States, United Kingdom
- Volunteers
- 190 people
- Sponsor
- Janssen Research & Development, LLC
High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free…
- Trial name
- NCT06099990
- Testing
- dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets
- Volunteers
- 660 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
MRD, Prostate Cancer
Minimal Residual Disease Used in Predicting Therapeutic Efficacy in Metastatic Hormone-sensitive Prostate Cancer
This study is a prospective, single-center, observational study of patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC).
- Conditions
- MRD, Prostate Cancer, mHSPC
- Trial name
- NCT07112612
- Volunteers
- 50 people
- Sponsor
- Anhui Medical University
Prostate Cancer, Prostate Cancer Recurrent
Metastasis-directed Therapy for Oligorecurrent Prostate Cancer
The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed…
- Conditions
- Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic, Metastatic Cancer
- Trial name
- SPARKLE (NCT05352178)
- Testing
- Radiotherapy (SBRT) and/or surgery (metastasectomy), Androgen deprivation therapy, Androgen receptor targeted therapy
- Where
- Belgium
- Volunteers
- 873 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Metastatic Prostate Cancer
Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan in China(PSMAreal CN)
This non-interventional, observational, multicenter, prospective cohort study is designed to investigate the treatment patterns of mPC patients treated with lutetium (177Lu) vipivotide tetraxetan, as well as their clinical…
- Trial name
- PSMAreal (NCT07290270)
- Where
- China
- Volunteers
- 170 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer, Prostate Adenocarcinoma
PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
The purpose of this prostate cancer research study is to learn about: 1. Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen…
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Hormone Sensitive Prostate Cancer
- Trial name
- OCEAN (NCT06392295)
- Testing
- Para Aortic Radiation Therapy: Photon Therapy, Para Aortic Radiation Therapy: Proton Therapy, Androgen Deprivation Therapy
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- University of Miami
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
Prostate Adenocarcinoma, Castration Sensitive Prostate Cancer
Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)
The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT…
- Trial name
- RATIONAL (NCT06654336)
- Testing
- Recurrence-directed therapy (RDT), ELIGARD 22.5mg
- Where
- 5 sites in Canada
- Volunteers
- 162 people
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
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
Hormone-refractory Prostate Cancer
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
There are many treatment options for men with various stages of prostate cancer. Some treatments work well for a while but can cause medical problems in some men. Also, the cancer may come back after treatment.
- Trial name
- NCT05997615
- Testing
- VIR-5500, Androgen receptor signaling inhibitor (ARSI), Docetaxel
- Where
- 26 sites in United States, Australia and 2 more
- Volunteers
- 347 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Hormone-Sensitive Prostate Cance
Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer
GUARD-QUANTUM is a prospective, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study. The rationale behind studying this combination lies in the potential additive or synergistic benefits that may arise…
- Trial name
- GUARD-QUANTUM (NCT07717099)
- Testing
- Ra223, Darolutamide Oral Tablet, Androgen Deprivation Therapy (ADT)
- Where
- 12 sites in Spain
- Volunteers
- 50 people
- Sponsor
- Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
mHSPC, mHNPC
Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer
This study is a single-centre, randomised, paired 24-week intervention dosing trial. Its purpose is to evaluate the safety profile and efficacy of the investigational drug in subjects with metastatic hormone-sensitive prostate…
- Conditions
- mHSPC, mHNPC, Prostate Cancer Adenocarcinoma
- Trial name
- NCT07389174
- Testing
- Standard Endocrine Therapy, LC-K76
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Changzheng Hospital
BRCA-Mutated, Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer
Carboplatin-Enhanced Therapy in BRCA-Mutated or Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer
The current standard of patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) is to offer androgen deprivation therapy (ADT) with androgen receptor pathway inhibitors (ARPI).
- Conditions
- BRCA-Mutated, Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer, Prostate Cancer
- Trial name
- CaBRA (NCT07591467)
- Testing
- Experimental
- Where
- 5 sites in France
- Volunteers
- 330 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris