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