Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Not specified	NCI	MAYO-700 7-00, NCT00684905

Objectives

1. 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.
2. Determine the toxicity of interstitial brachytherapy combined with androgen-deprivation therapy in these patients.
3. Determine the tumor response to interstitial brachytherapy combined with androgen-deprivation therapy in these patients.

Entry Criteria

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

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior transurethral resection of the prostate

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

Expected Enrollment

Outcomes

Feasibility
Patient tolerance
Toxicities
Tumor response

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.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Scottsdale

William Wong, MD, Protocol chair		Ph: 480-301-8120
Steven Schild, MD, Protocol co-chair		Ph: 480-301- Email: sschild@mayo.edu

Registry Information
Official Title		Phase II Interstitial Brachytherapy Combined with Androgen Deprivation Therapy for Locally Recurrent Prostate Cancer After Prior External Beam Irradiation
Trial Start Date		2000-04-25
Trial Completion Date		2025-04-25 (estimated)
Registered in ClinicalTrials.gov		NCT00684905
Date Submitted to PDQ		2008-02-26
Information Last Verified		2008-05-13
NCI Grant/Contract Number		CA15083

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