NCT03141671

Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509)

Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone Acetate and Apalutamide (ARN-509) for Rising PSA After Radical Prostatectomy With Adverse Features.(FORMULA-509 Trial)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

This research study is comparing two different combinations of androgen deprivation therapy (ADT) used together with radiation as a treatment for rising PSA after radical prostatectomy (prostate cancer).

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and 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. Currently, the best standard treatment for men with this type of prostate cancer includes radiation therapy combined with androgen deprivation therapy (ADT). ADT blocks the function of hormones including testosterone which prostate cancer uses to grow and spread. All participants in this study will receive the main standard form of ADT called a luteinizing hormone-releasing hormone agonist (LHRHA). Physicians often also use another drug called bicalutamide to help the LHRHA block hormone function. The investigators are testing whether using two newer anti-hormonal drugs called abiraterone acetate and apalutamide with LHRHA can improve cure rates compared to using bicalutamide plus LHRHA. These two drugs work together to suppress both testosterone and the receptor where testosterone binds thereby providing more potent hormone suppression.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	GnRH	-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread
DRUG	Bicalutamide	-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread
RADIATION	Salvage radiation	Radiation
DRUG	Abiraterone	-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread
DRUG	Prednisone	Prednisone is a corticosteroid. It prevents the release of substances in the body that cause inflammation. It also suppresses the immune system.
DRUG	Apalutamide	-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

Timeline

• Start date: 2017-11-24
• Primary completion: 2025-04-05
• Completion: 2025-12-31
• First posted: 2017-05-05
• Last updated: 2024-05-14

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study