RTOG-0924

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

Principal Investigator

Mack Roach

Status

Disease Site

Genitourinary [GU] Prostate

Phase

III

Developmental Therapeutics

No

Primary Objective

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.

Patient Population

Patient Population:  

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.

 

Target Accrual

2580