Androgen-Deprivation and Radiation Therapy for Prostate Cancer

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial

February 21, 2018

  • Clinical Trial Information

    Trial Contact: Ford, Elizabeth; Frankos, Marie

    Trial Phone: 321.841.7413 ; 321.841.7303

  • IRB No: RTOG-0924

    Protocol Abbrev: RTOG-0924

    Principal Investigator: Akash Nanda, MD, PhD

    Sub Investigators: Manon, Rafael MD; Hajdenberg, Julio MD; Landau, Daniel MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: RTOG-0924

    Treatment: radiation therapy, Whole-pelvic radiotherapy (WPRT), Androgen Deprivation Therapy

    Applicable Disease Sites: Prostate Cancer

    Therapies Involved: Radiation

    ClinicalTrials.gov ID: NCT01368588

  • Objective

    Demonstrate that prophylactic, neoadjuvant, androgen-deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) will result in improvement in overall survival (OS) of patients with "unfavorable" intermediate-risk or "favorable" high-risk prostate cancer compared to NADT and high-dose prostate (P) and seminal vesicle (SV) radiation therapy (RT) using intensity-modulated RT (IMRT) or external-beam RT (EBRT) with a high-dose rate (HDR) or a permanent prostate (radioactive seed) implant (PPI) boost.

  • Key Eligibility

    - Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence
    - Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable
    high risk disease
    - Clinically negative lymph nodes as established by imaging
    - No evidence of bone metastases (M0) on bone scan