Radiation Therapy After Prostatectomy in Treating Patients With Stage III Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00394511|
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : February 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: low-LET photon therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||408 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||December 2006|
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.