Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer

Sponsor
Instituto do Cancer do Estado de São Paulo
Study ID
NCT02789878
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Goserelin — DRUG
    Androgen Deprivation Therapy
  • Prednisone — DRUG
    Corticosteroid
  • Abiraterone — DRUG
    CYP17 inhibitor
  • Apalutamide — DRUG
    Androgen-receptor antagonist

Study Details

This is a randomized study to evaluate the efficacy and safety neoadjuvant androgen deprivation therapy with goserelin and abiraterone with or without apalutamide prior to radical prostatectomy for patients diagnosed with localized high-risk prostate cancer.

Key Dates

Start date
Jan 24, 2019
Status verified
Sep 2022
Primary completion
Apr 30, 2022
Completion
Aug 1, 2022

Study Design

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

Arms

  • Experimental: ADT and Abiraterone
    * Goserelin 10.8 mg, single dose, subcutaneously. * Abiraterone 1,000 mg, once daily, orally for 3 months. * Prednisone 5 mg, once daily, orally for 3 months.
  • Experimental: ADT, Abiraterone and Apalutamide
    * Goserelin 10.8 mg, single dose, subcutaneously. * Abiraterone 1,000 mg, once daily, orally for 3 months. * Prednisone 5 mg, once daily, orally for 3 months. * Apalutamide 240 mg, once daily, orally for 3 months.

Primary Outcome Measure

Pathologic response [ Time Frame: 3 months ]

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