NCT00005939

Brachytherapy in Treating Patients With Recurrent Prostate Cancer

Phase I/II Study of Interstitial Colloidal 32P for Locally Recurrent Prostate Cancer Failing Radiation

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Center for Molecular Medicine · Academic / Other
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy radiation to damage tumor cells. Brachytherapy uses radioactive material that is placed directly into or near the tumor. Brachytherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating patients who have recurrent prostate cancer that has not responded to standard therapy.

Detailed description

OBJECTIVES: I. Determine the dosimetry and toxicity of interstitial colloidal phosphorus P32 (cP32) in patients with locally recurrent prostate cancer that has failed conventional therapy. II. Determine the maximum tolerated dose of interstitial cP32 when combined with interstitial macroaggregated albumin (infusional brachytherapy) in these patients. III. Determine the therapeutic response rate to acceptable single doses of cP32 in these patients. OUTLINE: This is a dose escalation study of colloidal phosphorus P32 (cP32). Patients receive cP32 and macroaggregated albumin via interstitial infusion using ultrasound localization. Cohorts of 3 patients receive escalating doses of cP32 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 4 patients experience dose limiting toxicities. Additional patients are treated at the MTD. Patients are followed at 1, 2, 4, and 6 weeks; then at 2, 4, 8, 12, 16, 20, and 24 months; and then every 6 months thereafter until death. PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for phase I of the study and a total of 40 patients will be accrued for phase II of the study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	brachytherapy
RADIATION	phosphorus P32

Timeline

• Start date: 1999-11-01
• First posted: 2004-05-26
• Last updated: 2013-11-06

Locations

1 site across 1 country: United States