Clinical trials: Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
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
Metastatic Hormone-Sensitive Prostate Cancer, Prostate Cancer
PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.
This multicenter retrospective study developed and validated a prediction model based on PSMA PET/CT and routine clinical information to estimate early treatment response in patients with metastatic hormone-sensitive prostate…
- Trial name
- NCT07428642
- Testing
- Androgen Deprivation Therapy, Apalutamide, Enzalutamide
- Where
- China
- Volunteers
- 168 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
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)
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Deleterious HRR Gene Mutation
Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
This is an open label, phase II trial in subjects with treatment naïve, metastatic hormone sensitive prostate cancer (mHSPC) with deleterious homologous recombination repair (HRR) alteration(s).
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Deleterious HRR Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation
- Trial name
- HARMONY (NCT06392841)
- Testing
- Androgen Deprivation Therapy (ADT), Niraparib/Abiraterone Acetate DAT, Abiraterone Acetate
- Sponsor
- Qian Qin
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
Prostate Cancer Metastatic
REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer
The primary objective is to determine the safety and activity of combined hormonal chemoimmunotherapy in a single-arm phase II trial of REGN2810, androgen deprivation therapy (ADT), and docetaxel in patients with newly…
- Trial name
- NCT03951831
- Testing
- REGN2810, Degarelix, Leuprolide Acetate
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Mark Stein
Metastatic Hormone-sensitive Prostate Cancer
A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
The purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate…
- Trial name
- ArtemisPRO (NCT05901649)
- Testing
- Apalutamide, Enzalutamide
- Where
- 53 sites in Austria, France and 4 more
- Volunteers
- 505 people
- Sponsor
- Janssen-Cilag Ltd.
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, Prostate Cancer
Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
The goal of this research study is to determine whether hormonal therapies used early in the course of prostate cancer could increase the amount of Prostate-Specific Membrane Antigen (PSMA) as detected by PET/CT scans for…
- Conditions
- Prostate Adenocarcinoma, Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT05683964
- Testing
- Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi], Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Beth Israel Deaconess Medical Center
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
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer
This study aims to compare the efficacy and safety of rezvilutamide with enzalutamide in the treatment of patients with low-volume metastatic hormone sensitive prostate cancer.
- Trial name
- NCT07241416
- Testing
- Rezvilutamide Tablets, Enzalutamide Soft Capsules
- Where
- China
- Volunteers
- 206 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Castration-Sensitive Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8
Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)
This phase II trial examines antiandrogen therapy interruptions in patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic) responding exceptionally well to androgen…
- Trial name
- A-DREAM (NCT05241860)
- Testing
- Pharmacotherapy Discontinuation, Follow-Up, Questionnaire Administration
- Where
- 326 sites in United States
- Volunteers
- 79 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Metastatic Prostate Cancer, Therapy, Directly Observed
Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients
To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy…
- Trial name
- NCT06350825
- Testing
- Cytoreductive prostatectomy or brachytherapy, ADT+second-generation antiandrogens ± chemotherapy
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Metastatic Hormone-sensitive Prostate Cancer
A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.
The purpose of the study is to assess if the addition of darolutamide to ADT compared with ADT alone would result in superior clinical efficacy in participants with metastatic hormone-sensitive prostate cancer (mHSPC) by…
- Trial name
- ARASEC (NCT05059236)
- Testing
- Darolutamide (BAY1841788, Nubeqa), ADT
- Where
- 31 sites in United States
- Volunteers
- 223 people
- Sponsor
- Bayer
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
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 Hormone-sensitive Prostate Cancer (mHSPC)
How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany
Prostate cancer is a disease where cells in the prostate gland grow out of control. When prostate cancer has spread to other parts of the body but still responds to hormone treatment, it is called metastatic hormone-sensitive…
- Trial name
- 23146 (NCT07395804)
- Testing
- darolutamide plus ADT treatment
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Bayer
Metastatic Prostate Cancer, Prostate Cancer (Adenocarcinoma)
CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate Cancer
This is a prospective, randomized, open-label, phase II multicenter clinical trial evaluating the efficacy and safety of radical prostatectomy in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) who…
- Conditions
- Metastatic Prostate Cancer, Prostate Cancer (Adenocarcinoma), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- CONVERT-HB1 (NCT07268794)
- Testing
- Androgen Deprivation Therapy (ADT), Docetaxel, PARP Inhibitors and Other Systemic Agents
- Where
- China
- Volunteers
- 112 people
- Sponsor
- Fudan University
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
An Observational Study to Learn More About Treatment Patterns and Factors Determining the Choice of Treatment in Canadian Men With Metastatic Hormone Sensitive Prostate Cancer in Routine Medical Care
This is an observational study in which only data are collected from adult Canadian men with metastatic hormone sensitive prostate cancer (mHSPC) are studied.
- Trial name
- RE-ENGAGE (NCT06874114)
- Where
- Canada
- Volunteers
- 477 people
- Sponsor
- Bayer