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AFT-19

Trial Overview

Official Title

A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

Study Purpose

To compare progression free survival and overall survival of the standard hormone therapy degarelix verses  degarelix and apalutamide versus degarelix, apalutamide, abiraterone, and prednisone.

Diagnosis

Prostate Adenocarcinoma that is detected in the blood with a PSA doubling time of less than 9 months..

Eligibility

Prior therapy: radiation therapy OR not a candidate for radiation therapy

Patients are not eligible if they have evidence of metastatic cancer

Patients who have had previous androgen deprivation therapy must have had the last dose > 9 months ago

Must not have had prior chemotherapy unless it was given immediately before or immediately after surgery

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

  • Hormone Therapy : DegarelixApalutamideAbiraterone + Prednisone
  • Lab Biomarker Analysis
  • Quality of Life Questionnaires
  • Arm I: Will receive standard of care Degarelix injections every 28 days for 13 cycles (12 months).
  • Arm II: Will receive Degarelix injections every 28 days and take Apalutamide orally once a day for 13 cycles (12 months).
  • Arm III: Will receive Degarelix injections every 28 days, take Apalutamide orally once a day, take Abiraterone orally once a day, and take prednisone once a day for 13 cycles (12 months).

After completion of study therapy, monthly labs will be drawn until prostate cancer is detected. 

Patients will then have CT scans at that time and then have scans every 6 months and will be followed by staff to document other anticancer treatment details and survival.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male
Age
19 years and older
Phase
Phase III
Methodist Health System Trial Code
AFT-19
Related Specialties