Radiation Therapy After Prostatectomy in Treating Patients With Stage III Prostate Cancer
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Evaluation of Adjuvant Radiotherapy vs No Adjuvant Therapy Following Radical Prostatectomy and Pelvic Lymphadenectomy in Surgical Stage C Adenocarcinoma of the Prostate|
|Study Start Date:||August 1988|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV.
|Procedure: low-LET photon therapy|
No Intervention: Arm II
No further treatment.
I. Compare disease-free survival rates of patients randomly assigned to adjuvant external-beam radiotherapy vs. no adjuvant therapy following radical prostatectomy and pelvic lymphadenectomy for surgical Stage C (T3 N0 M0) adenocarcinoma of the prostate.
II. Determine the qualitative and quantitative toxicities associated with this adjuvant therapy.
OUTLINE: Randomized study. Randomization takes place when the patient is physically able to begin treatment, any time within 16 weeks after surgery.
Arm I: Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV.
Arm II: No further treatment.