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

Trial Information

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

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.