Radiation Therapy After Prostatectomy in Treating Patients With Stage III Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: low-LET photon therapy

• Registration Number: NCT00394511
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Randomized phase III trial to compare treatment with or without adjuvant radiation therapy in men with stage III prostate cancer who have had radical prostatectomy and lymphadenectomy recently. Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.

Detailed Description

OBJECTIVES:

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 Timeline

• Study Start: 1988-08
• Status Verified: 2006-10
• Study First Submitted: 2006-10-31
• Study First Submitted QC: 2006-10-31
• Study First Posted: 2006-11-01
• Primary Completion: 2006-12
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 408

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	low-LET photon therapy	Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV.