Clinical trials: Metastatic Hormone-sensitive Prostate Cancer (mHSPC), open to volunteers
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
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
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
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 (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
AI-Assisted Patient Support in mHSPC
The purpose of this multicenter, open-label, randomized controlled trial is to evaluate whether patient-centered support delivered through a large language model (LLM)-based artificial intelligence (AI) agent reduces anxiety in…
- Trial name
- LUMINOUS (NCT07804030)
- Testing
- The Same Platform without AI Agent, AI Agent-Assisted Patient-Centered Support, Delayed AI Agent-Assisted Patient-Centered Support
- Where
- 4 sites in China
- Volunteers
- 160 people
- Sponsor
- Fudan University
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC
This is a multicenter, randomized, open-label phase 2 study for men with metastatic hormone-sensitive prostate cancer. About 254 participants will first receive 6 months of darolutamide plus androgen deprivation therapy.
- Trial name
- PSMA-DaroRT (NCT07649421)
- Testing
- Stereotactic Body Radiotherapy (SBRT), Darolutamide 600 mg twice daily, Androgen Deprivation Therapy (ADT)
- Where
- China
- Volunteers
- 254 people
- Sponsor
- West China Hospital
Prostate Cancer Metastatic
Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
PEACE-6 Poor Responders is an international, multicenter, open-label, controlled, randomized, phase III trial to evaluate the efficacy and safety of 177Lu-PSMA-617 when administered on top of the ongoing standard systemic…
- Trial name
- NCT06496581
- Testing
- 177Lu-PMSA-617, Standard of Care
- Where
- 25 sites in France
- Volunteers
- 500 people
- Sponsor
- UNICANCER
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
The purpose of this study is to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.
- Trial name
- OPTIMAS (NCT07216248)
- Testing
- relugolix + ARPI, Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI, relugolix or androgen deprivation therapy (ADT) + ARPI
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- University of Utah
Prostatic Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
This study aims to explore the real-world treatment adherence, persistence of apalutamide, and assess the risk of non-adherence according to the participant's profile and behavior of metastatic hormone-sensitive prostate cancer…
- Trial name
- OBSAPA (NCT07451002)
- Where
- France
- Volunteers
- 540 people
- Sponsor
- Janssen Cilag S.A.S.
Metastatic Prostate Cancer, Intermitent Anti-androgen Therapy
Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.
- Trial name
- NCT06177015
- Testing
- Darolutamide continuous, Darolutamide intermittent
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Testosterone-Informed De-Escalation in Metastatic Prostate Cancer (TIDE PC)
The purpose of this study is to use androgen deprivation therapy (ADT) intermittently in hopes of reducing side effects from ADT and reducing unnecessary dosing of ADT in adult men with a prolonged response to frontline therapy…
- Trial name
- NCT07904026
- Testing
- Androgen Deprivation Therapy (ADT), Androgen Receptor Pathway Inhibitors (ARPIs)
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University of Nebraska