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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03777982
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prednisone — DRUG
    Taking advantage of the anti-inflammatory properties of the medication, corticosteroids are used to decrease the swelling around tumors.
  • Apalutamide — DRUG
    Apalutamide also prevents the androgens from working within the prostate cancer cells, and can ultimately lead to cancer cell death.
  • Abiraterone Acetate — DRUG
    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
  • LHRH Agonist or Antagonist — DRUG
    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

Study Details

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

Key Dates

Start date
Apr 20, 2020
Status verified
Sep 2024
Primary completion
Feb 13, 2024
Completion
Feb 13, 2024

Study Design

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

Arms

  • Experimental: LHRH Agonist or Antagonist
    -LHRH agonist or antagonist should be prescribed per standard of care
  • Experimental: Prednisone+Apalutamide+Abiraterone Acetate +LHRH Agonist
    * LHRH agonist or antagonist should be prescribed per standard of care * Abiraterone acetate will be taken once daily * Prednisone will be taken twice daily * Apalutamide will be taken once daily

Primary Outcome Measure

Metastasis Free Survival [ Time Frame: 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical CenterMilfordMassachusetts01757-
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore HospitalSouth WeymouthMassachusetts02190-

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Beth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MADana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center· Milford, MADana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital· South Weymouth, MA

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