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

Phase 1/Phase 2
21 Years
Open (Enrolling)
Prostate Cancer

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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

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven locally recurrent prostate cancer that has
failed conventional therapy (i.e., external beam radiotherapy, radioactive seed implants,
and hormonal therapy) Must be confirmed clinically with elevated PSA and/or ultrasound
Prostates between 2-5 cm in diameter (i.e., volumes of 4-65 cm3) preferred Prostates
greater than 5 cm allowed, but 2 needles required for good distribution of study drug No
clinical/radiographic evidence of metastatic disease No history of injury to urethra,
bladder, or rectum

PATIENT CHARACTERISTICS: Age: 21 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least
1,900/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (transfusion
allowed) Hepatic: Not specified Renal: Blood urea nitrogen no greater than 25 mg/dL
Creatinine no greater than 1.5 mg/dL

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics
Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Wayne S. Court, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Center for Molecular Medicine


United States: Federal Government

Study ID:




Start Date:

November 1999

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Center for Molecular Medicine Garden City, New York  11530