I-125 Versus Pd-103 for Low Risk Prostate Cancer

VA Puget Sound Health Care System

Status and phase: Unknown; Phase 3

Conditions: Prostate Cancer

Treatments: Procedure: Radioactive seed implant to prostate

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00494039

IP

Details and patient eligibility

About

Objective: To test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy).

Full description

Objective: To test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy).

Methodology: Patients will be randomized by the method of random permuted blocks.

Cancer status will be monitored by serial serum PSA at 6, 12, 18 and 24 months and yearly thereafter. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months. Patients with serum PSA above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy.

Enrollment: 602 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males age 40-80
• PSA 4-10
• Gleason score 5-6

Exclusion criteria

• Lymph node positive

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)