Clinical trials: Hormone Sensitive Prostate Cancer, active
Metastatic Castrate-sensitive Prostate Cancer
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level…
- Trial name
- LIBERTAS (NCT05884398)
- Testing
- Apalutamide, Androgen-deprivation Therapy (ADT)
- Where
- 93 sites in United States, Australia and 7 more
- Volunteers
- 420 people
- Sponsor
- Janssen Research & Development, LLC
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, 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)
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
Prostate Cancer (Adenocarcinoma)
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs? This study would like to find out if this approach…
- Trial name
- TRIPLE-SWITCH (NCT06592924)
- Testing
- Abiraterone, Enzalutamide, Apalutamide
- Where
- 395 sites in United States, Canada and 2 more
- Volunteers
- 830 people
- Sponsor
- Canadian Cancer Trials Group
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
Prostate Cancer, Stage IV Prostate Cancer
First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer
The goal of this clinical research is to find if sequential therapy with combined androgen deprivation or hormonal therapy with luteinizing hormone release hormone (LHRH) analog plus a new hormonal agent (abiraterone…
- Trial name
- NCT05189457
- Testing
- Luteinizing Hormone Releasing Hormone, New Hormonal Agent, Docetaxel
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Cancer, Urology
Monitoring Treatment Response With Urine and Serum Metabolome Markers in Patients Treated With Novel Hormone Therapy and Have Either Hormone Sensitive Metastatic Prostate Cancer or Disease Progression on Treatment.
80% of patients with newly diagnosed metastatic hormone sensitive prostate cancer have bone metastases. There are mutations that are described with early disease progression when on hormone therapy for prostate cancer.
- Trial name
- Metabolome-PC (NCT07837063)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
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
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
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
Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body.
- Conditions
- Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT07005154
- Testing
- ASP5541, Prednisone, Prednisolone
- Where
- 54 sites in United States, China and 10 more
- Volunteers
- 218 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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
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
Oligoprogressive Prostate Cancer, Metastatic Prostate Cancer
PSMA PET-Staged Comprehensive Progression-Directed Radiotherapy for Limited Progression in Prostate Cancer
PSMA-OLIGO-PRO is a multicenter, ambispective, observational real-world evidence registry of adults with metastatic hormone-sensitive or metastatic castration-resistant prostate cancer who develop a limited number of progressing…
- Trial name
- PSMA-OLIGO-PRO (NCT07691697)
- Testing
- Comprehensive Progression-Directed Radiotherapy
- Where
- Poland
- Volunteers
- 1,000 people
- Sponsor
- Affidea Nu-med Center of Oncological DIagnostics and Therapy
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