RTOG-0126

A Phase III Randomized Study of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT in Patients Treated for Localized Prostate Cancer

Principal Investigator

Jeff Michalski, MD

Status

Disease Site

Genitourinary [GU] Prostate

Phase

III

Developmental Therapeutics

No

Primary Objective

Determine whether 3D-CRT/IMRT to 79.2 Gy in 44 fractions will lead to improved overall survival in patients treated for prostate cancer compared to a group of patients treated with 3D-CRT/ IMRT to 70.2 Gy in 39 fractions.

Patient Population

Histologically confirmed prostate adenocarcinoma within 180 days of randomization
Zubrod Performance Scale 0-1
Prostatic biopsy tumor grading by the Gleason Score Classification
One of the following combinations of factors:
• Clinical stage T1b-T2b, Gleason score 2-6, and prostate-specific antigen > =10 but < 20
• Clinical stage T1b-T2b, Gleason score 7, and prostate-specific antigen < 15
Clinically negative lymph nodes or histologically negative by nodal sampling or dissection
No distant metastases (M0)
No previous or concurrent invasive cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years
No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
No previous or concurrent cytotoxic chemotherapy for this cancer
No previous hormonal treatment (no finasteride or phytoestrogen preparation within 3 months prior to registration)
– No radical surgery or cryosurgery for prostate cancer
– Pretreatment evaluations must be completed as specified in Section 4.1
 

Target Accrual

1520