Clinical Trials Logo
  1. Home
  2. Stage IV Prostate Cancer AJCC v8
  3. NCT06173362

Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

Stage IV Prostate Cancer AJCC v8 Clinical Trial

Official title:
A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide

Clinical Trial Summary

This phase II trial compares the effects, good and/or bad of abiraterone and prednisone or darolutamide alone in treating patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Androgens (male hormones) can cause the growth of prostate tumor cells. Abiraterone acetate lowers the amount of androgens made by the body. This may help stop the growth of prostate tumor cells that need androgen to grow. Darolutamide blocks the use of androgens by the tumor cells. Prednisone is used to lessen inflammation and lower the body's immune response. Researchers want to compare the side effects of standard of care (SOC) abiraterone and prednisone or darolutamide alone in treating patients with advanced prostate cancer.

Clinical Trial Description

PRIMARY OBJECTIVE: I. Tolerability. SECONDARY OBJECTIVES: I. Tolerability in prespecified subpopulations. II. Prostate-specific antigen (PSA) response at 7 months. OUTLINE: Patients are assigned to 1 of 2 arms per treating physician preference. ARM I: Patients receive abiraterone and prednisone per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study. ARM II: Patients receive darolutamide per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study. After completion of study intervention, patients are followed up for a total of 3 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06173362
Study type Interventional
Source University of California, Davis
Contact
Status Recruiting
Phase Phase 2
Start date November 9, 2023
Completion date May 2027
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04716725 - 68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer Phase 2
Withdrawn NCT05034562 - Gallium-68 PSMA-11 PET in Participants With Prostate Cancer Phase 2
Recruiting NCT03678025 - Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer Phase 3
Active, not recruiting NCT03218826 - PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Recruiting NCT04071236 - Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy Phase 1/Phase 2
Completed NCT04976257 - Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion Early Phase 1
Withdrawn NCT04585932 - Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study Phase 2
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Active, not recruiting NCT05241860 - Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM) Phase 2
Not yet recruiting NCT06129851 - Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer Phase 2
Not yet recruiting NCT05487846 - Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation N/A
Recruiting NCT04314401 - National Cancer Institute "Cancer Moonshot Biobank"
Recruiting NCT04734730 - Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer Phase 2
Active, not recruiting NCT03517969 - M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castration-Resistant Prostate Cancer Phase 2
Recruiting NCT04777071 - An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer Phase 2
Active, not recruiting NCT03360721 - Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05054296 - Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring Phase 2
Recruiting NCT04693377 - Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial N/A
Recruiting NCT05168618 - Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer, The AtezoCab Trial Phase 2
Recruiting NCT05445609 - Vidutolimod (CMP-001) in Combination With Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer Phase 2