A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Thomas M. Pisansky, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000069248
NCT ID:
NCT00032006
Start Date:
February 2002
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- recurrent prostate cancer
- Adenocarcinoma
- Prostatic Neoplasms
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
| Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
| Mayo Clinic | Jacksonville, Florida 32224 |
