Brachytherapy in Treating Patients With Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005939
Recruitment Status : Unknown
Verified February 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : May 26, 2004
Last Update Posted : November 6, 2013
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: brachytherapy Radiation: phosphorus P32 Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Interstitial Colloidal 32P for Locally Recurrent Prostate Cancer Failing Radiation
Study Start Date : November 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005939

United States, New York
Center for Molecular Medicine
Garden City, New York, United States, 11530
Sponsors and Collaborators
Center for Molecular Medicine
Study Chair: Wayne S. Court, MD, PhD Center for Molecular Medicine Identifier: NCT00005939     History of Changes
Other Study ID Numbers: CDR0000067749
First Posted: May 26, 2004    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: February 2001

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases