Leuprolide, Bicalutamide, and Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer After External-Beam Radiation Therapy

Prostate Cancer Clinical Trial

Official title:

Phase II Interstitial Brachytherapy Combined With Androgen Deprivation Therapy for Locally Recurrent Prostate Cancer After Prior External Beam Irradiation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684905
• Other study ID #: 07-00
• Secondary ID: P30CA0150837-007
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2008
• Last updated: November 9, 2012
• Start date: April 2000
• Est. completion date: October 2005

Study information

• Verified date: November 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide and bicalutamide, may lessen the amount of androgens made by the body. Implant radiation therapy kills tumor cells by placing material such as radioactive iodine directly into or near a tumor. Giving leuprolide and bicalutamide together with implant radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving leuprolide and bicalutamide together with implant radiation therapy and to see how well it works in treating patients with locally recurrent prostate cancer after external-beam radiation therapy.

Description:

OBJECTIVES:

• Determine the feasibility and patient tolerance of interstitial brachytherapy combined with androgen-deprivation therapy for patients with locally recurrent prostate cancer after prior external-beam irradiation.

• Determine the toxicity of interstitial brachytherapy combined with androgen-deprivation therapy in these patients.

• Determine the tumor response to interstitial brachytherapy combined with androgen-deprivation therapy in these patients.

OUTLINE: Patients receive neoadjuvant therapy comprising leuprolide acetate intramuscularly for 3 months and oral bicalutamide once daily for 30 days, beginning on the first day of leuprolide acetate administration. Patients then undergo interstitial brachytherapy implantation with I-125. Following brachytherapy, patients receive adjuvant leuprolide acetate every 3 months for an additional 6 months.

Quality of life is assessed at baseline and at every treatment and follow-up visit.

After completion of study therapy, patients are followed every 3 months for 2 years, every to 4-6 months for 3 years, and then annually thereafter.

Other known NCT identifiers

• NCT00956995

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Biopsy-proven adenocarcinoma of the prostate

• Locally recurrent disease, defined by digital rectal examination and/or rising prostate-specific antigen (PSA)

• No evidence of nodal or distant metastasis (i.e., N0, M0) on physical examination, bone scan, or CT scan of the pelvis

• Clinical stage T1c-T3a disease at the time of recurrence

• PSA < 10 ng/mL

• Prostate volume by transrectal ultrasonography < 60 cc

• Received prior external beam radiotherapy

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• WBC = 3,000/µL

• Platelet count = 90,000/µL

• Hemoglobin = 10 g/dL

• Alkaline phosphatase < 2 times normal

• AST < 2 times normal

• Normal prothrombin time and partial thromboplastin time

• No significant obstructive urinary symptoms (AUA score = 16)

• No contraindication for general anesthesia

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior transurethral resection of the prostate

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• bicalutamide

• leuprolide acetate

Procedure:
• adjuvant therapy

• neoadjuvant therapy

• quality-of-life assessment

Radiation:
• brachytherapy

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility			No
Primary	Patient tolerance			Yes
Primary	Toxicities			Yes
Primary	Tumor response			No