NCT03777982

Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT

A Randomized Phase III Study - Conventional Androgen Deprivation Therapy With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and Androgen Deprivation Therapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is being offered to those patients who have received radiation therapy and who are receiving long-term hormonal therapy for their prostate cancer and whose PSA remains detectable despite having received at least 6, but no more than 12 months of hormonal therapy. The name of the study drugs involved in this study is: * LHRHA (luteinizing hormone-releasing hormone agonist or antagonist) * Abiraterone Acetate * Apalutamide * Prednisone

Detailed description

This research study is a Phase III clinical trial. Phase III clinical trials test the effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that an intervention is being studied. In this study, the investigational agents are apalutamide and abiraterone acetate. Abiraterone acetate (used in combination with prednisone) is an FDA (the U.S. Food and Drug Administration) approved drug for prostate cancer, but is approved in patients that have prostate cancer spread to other parts of their body and have been previously treated with ADT. Apalutamide has also been approved by the FDA for men whose cancer does not respond to hormone therapy but it is still investigational for this type of cancer. In this research study, the investigators are looking at two methods of androgen deprivation therapy (ADT), also known as hormonal therapy, to determine which method is better for improving long term cure rates. ADT blocks the function of hormones, including testosterone which prostate cancer uses to grow and spread. The first method of ADT includes prednisone, apalutamide, and abiraterone acetate plus standard ADT and the second method of ADT is standard ADT alone for men with this type of prostate cancer. Currently, the best standard treatment for men with this type of prostate cancer includes standard ADT. All participants in this study will receive the main standard form of ADT called a luteinizing hormone-releasing hormone agonist or antagonist (LHRHA).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Prednisone	Taking advantage of the anti-inflammatory properties of the medication, corticosteroids are used to decrease the swelling around tumors.
DRUG	Apalutamide	Apalutamide also prevents the androgens from working within the prostate cancer cells, and can ultimately lead to cancer cell death.
DRUG	Abiraterone Acetate	Abiraterone acetate interferes with an enzyme that is expressed in testicular, adrenal, and prostatic tumor tissues and is required as part of the body's androgen producing process. Because of this interference the amount of androgens produced are decreased. Abiraterone acetate, blocks androgen production at three sources; the testes, the adrenal glands, as well as from the tumor itself
DRUG	LHRH Agonist or Antagonist	Luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or GnRH agonists) are drugs that lower the amount of testosterone made by the testicles

Timeline

• Start date: 2020-04-20
• Primary completion: 2024-02-13
• Completion: 2024-02-13
• First posted: 2018-12-19
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study