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

Part of paid clinical trials in San Diego, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03141671
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Nov 24, 2017
Status verified
May 2024
Primary completion
Apr 5, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
345 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GnRH + Bicalutamide
    * GnRH agonist injection monthly or every 3 months for 6 months * Bicalutamide by mouth once/day for 6 months * Salvage radiation (starting 4-10 weeks after initiation of ADT)
  • Experimental: GnRH+Abiraterone+Apalutamide+Prednisone
    * GnRH agonist injection monthly or every 3 months for 6 months * Abiraterone acetate by mouth once/day for 6 months * Prednisone by mouth once/day for 6 months * Apalutamide by mouth once/day for 6 months * Salvage radiation (starting 4-10 weeks after initiation of ADT)

Primary Outcome Measure

PSA Progression Free Survival [ Time Frame: Up to 5 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92093-
University of California, San FranciscoSan FranciscoCalifornia94158-
Yale Cancer CenterNew HavenConnecticut06510-
University of ChicagoChicagoIllinois60637-
Dana-Farber Cancer Institute/Brigham and Women's HospitalBostonMassachusetts02215-
University of MichiganAnn ArborMichigan48109-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in San Diego, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California, San Diego· San Diego, CAUniversity of California, San Francisco· San Francisco, CAYale Cancer Center· New Haven, CTUniversity of Chicago· Chicago, ILDana-Farber Cancer Institute/Brigham and Women's Hospital· Boston, MAUniversity of Michigan· Ann Arbor, MI

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