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
Mack Roach, MD
Closed to Accrual
Date Opened To Accrual
July 16 2011
Date Closed to Accrual
June 24 2019
Demonstrate that prophylactic neoadjuvant androgen deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) will result in improvement in overall survival (OS) in patients with “unfavorable” intermediate risk or “favorable” high risk prostate cancer compared to NADT and high dose prostate and seminal vesicle (SV) radiation therapy (P + SV RT) using intensity modulated radiotherapy (IMRT) or EBRT with a high dose rate (HDR) or a permanent prostate (radioactive seed) implant (PPI) boost.
Protocol and Other Documents:
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website
Data Collection Notice:
Data for this trial is being collected via the NRG/RTOG Data Center.
Patients who are most likely to benefit from androgen deprivation therapy and whole-pelvic radiotherapy, defined as:
a) Having a significant risk of lymph node involvement (e.g. >15%, based on the Roach formula);
b) Being in one of the following risk groups:
GS 7-10 + T1c-T2b (palpation) + PSA < 50 ng/ml (includes intermediate and high risk patients);
GS 6 + T2c-T4 (palpation) + PSA < 50 ng/ml OR Gleason score 6 + ≥ 50% biopsies + PSA < 50 ng/ml;
GS 6 + T1c-T2b (palpation) + PSA > 20 ng/ml.
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.