Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer

Recruiting in Palo Alto (17 mi)

+35 other locations

Age: Any Age

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer.

Research Team

Paul H. Lange, MD

Principal Investigator

University of Washington

Eligibility Criteria

Inclusion Criteria

Histologically confirmed adenocarcinoma of the prostate within the past 120 days

T1c-T2a, N0, M0

No bilateral disease

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Treatment Details

Interventions

Internal Radiation (Brachytherapy)
Surgery (Surgery)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: surgeryExperimental Treatment1 Intervention

Patients undergo radical prostatectomy. Patients are followed every 6 months for 5 years and then annually thereafter.

Group II: radiationExperimental Treatment1 Intervention

Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds. Patients are followed every 6 months for 5 years and then annually thereafter.