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AFT-19

 

Status:

Recruiting | Phase III 

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 patients who receive the standard hormone therapy degarelix verses patients who receive degarelix and apalutamide versus patients who receive degarelix, apalutamide, abiraterone, and prednisone.

Interventions:   

  • Hormone Therapy : DegarelixApalutamideAbiraterone + Prednisone
  • Lab Biomarker Analysis
  • Quality of Life Questionnaires
  • Arm I: Patients will receive standard of care Degarelix injections every 28 days for 13 cycles (12 months).
  • Arm II: Patients will receive Degarelix injections every 28 days and take Apalutamide orally once a day for 13 cycles (12 months).
  • Arm III: Patients 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, patients will have monthly labs drawn until prostate cancer is detected.  Patients will then have CT scans at that time and then have scans every 6 months.  Patients will also be followed by staff to document other anticancer treatment details and survival.

Key Participation Requirements:

Gender:

Male

Age:

19 years and older

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

Patients 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.

Methodist Health System Trial Code:

AFT-19

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!