Clinical trials: Metastatic Castration-sensitive Prostate Cancer
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
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)
Prostate Cancer
A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer
This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive prostate cancer.
- Trial name
- NCT02059213
- Testing
- Ibrance, Bicalutamide, Zoladex
- Where
- 8 sites in United States
- Volunteers
- 72 people
- Sponsor
- University of Michigan Rogel Cancer Center
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
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
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 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
Metastatic Hormone-Sensitive Prostate Cancer
Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer
This multicenter, prospective, cohort study enrolled patients with metastatic hormone-sensitive prostate cancer who had been treated with other novel endocrine or systemic regimens (excluding patients treated with pre-order…
- Trial name
- RASTOM (NCT06134271)
- Testing
- Rezvilutamide, Rezvilutamide plus abiraterone, Continue previous treatment
- Volunteers
- 160 people
- Sponsor
- Jianbin Bi
Recurrent Prostate Cancer, Stage IV Prostate Cancer
Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer
Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent or metastatic prostate cancer.
- Trial name
- NCT00095667
- Testing
- lapatinib ditosylate, laboratory biomarker analysis
- Where
- Canada
- Volunteers
- 41 people
- Sponsor
- National Cancer Institute (NCI)
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma
Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer
This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other…
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
- Trial name
- NCT06305598
- Testing
- Biopsy, Bone Scan, Computed Tomography
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Roswell Park Cancer Institute
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