Hormone Therapy Followed By Internal Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer

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.

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

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:

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