RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining hormone therapy with internal radiation may be effective in treating locally recurrent prostate cancer.

PURPOSE: Phase II trial to study the effectiveness of hormone therapy followed by internal radiation in treating patients who have locally recurrent prostate cancer following external-beam radiation therapy.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer recurrent prostate cancer	Drug: bicalutamide  Drug: flutamide  Drug: goserelin  Drug: iodine I 125  Drug: leuprolide  Drug: palladium Pd 103  Procedure: antiandrogen therapy  Procedure: brachytherapy  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: isotope therapy  Procedure: neoadjuvant therapy  Procedure: radiation therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the nature, intensity, and time course of health-related quality of life changes in patients with locally recurrent prostate adenocarcinoma treated with androgen suppression and transperineal ultrasound-guided brachytherapy after external beam radiotherapy.
• Determine the morbidity of patients treated with this regimen.
• Determine the overall survival, disease-free survival, and disease-specific survival of patients treated with this regimen.
• Determine the clinical patterns of tumor recurrence (i.e., time to local tumor progression or distant failure) and time to biochemical failure of patients treated with this regimen.
• Determine the post-brachytherapy dosimetric coverage of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive androgen suppression comprising goserelin subcutaneously (as either 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection) OR leuprolide intramuscularly (as 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection or 1 four-month depot injection) AND oral flutamide 3 times daily for 112 days OR oral bicalutamide once daily for 112 days.

Within 4 weeks after completion of androgen suppression, patients are sequentially enrolled to 2 different cohorts of brachytherapy.

• Cohort 1: Patients undergo initial-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103.
• Cohort 2: After a minimum of 1-year follow-up for all patients in cohort 1, if tolerance is acceptable, additional patients undergo higher-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Quality of life is assessed at baseline, within 2 weeks prior to brachytherapy, every 3 months for 1 year, and then every 6 months for 2 years.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 83-166 patients (83 per cohort) will be accrued for this study within 1.5-3 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed locally recurrent or persistent prostate adenocarcinoma
• Locally recurrent disease
• Prostate-specific antigen (PSA) no greater than 10 ng/mL
• N0 and M0 (at time of initial diagnosis and at time of local recurrence)
• Lymph nodes must be negative or will be negative after nodal sampling or dissection
• More than 18 months after completion of prior external beam radiotherapy
• Must have had 1 of the following disease characteristics prior to external beam radiotherapy:
• T1-2a, Gleason score 2-6, and PSA no greater than 15 ng/mL
• T1-2a, Gleason score 7, and PSA no greater than 4 ng/mL
• T2b, Gleason score 2-6, and PSA no greater than 6 ng/mL
• Must have American Urological Association Symptom Index score no greater than 15
• Transrectal ultrasound-determined prostate planimetry volume no greater than 60 mL
• No pubic arch interference of more than 1/3 the prostatic volume determined by transrectal ultrasound or pelvic CT scan

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• Zubrod 0-1 OR
• ECOG 0-1

Life expectancy:

• At least 5 years

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No persistent late intestinal or bladder toxicity grade 2 or greater
• No other major medical or psychiatric illness that would preclude study
• No metallic hip prosthesis
• No other malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
• No other concurrent illness that would limit life expectancy
• Suitable for spinal or general anesthesia
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for prostate cancer

Endocrine therapy:

• At least 12 months since prior androgen suppression except goserelin or leuprolide with flutamide or bicalutamide begun within the past 30 days

Radiotherapy:

• See Disease Characteristics
• No prior external beam radiotherapy doses exceeding 71 Gy to the prostate
• No prior radionuclide prostate brachytherapy

Surgery:

• No prior transurethral prostate resection
• No prior prostatectomy or prostatic cryosurgery
• No prior bilateral orchiectomy

Other:

• No concurrent participation in another medical research study for prostate cancer treatment

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Florida
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States
Pennsylvania
      Allegheny General Hospital, Pittsburgh,  Pennsylvania,  15212-4772,  United States
Wisconsin
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States

Study chairs or principal investigators

Thomas Michael Pisansky, MD,  Study Chair,  Mayo Clinic Cancer Center   
Robert M. Arusell, MD,  Meritcare Roger Maris Cancer Center   

Study ID Numbers:  CDR0000069248; NCCTG-N0052
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  March 8, 2002
ClinicalTrials.gov Identifier:  NCT00032006
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08