Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate
OBJECTIVES:
Primary
- Determine the rate of late grade 3 or greater genitourinary and gastrointestinal
toxicity after treatment with external beam radiotherapy and high-dose rate
brachytherapy in patients with stage II or III adenocarcinoma of the prostate.
Secondary
- Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in
patients treated with this regimen.
- Determine freedom from biochemical failure in patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Determine disease-specific survival of patients treated with this regimen.
- Determine clinical relapse (local and/or distant) in patients treated with this
regimen.
- Develop a quality assurance process for high-dose rate prostate brachytherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to prostate-specific
antigen (≤ 10 ng/mL vs 11-20 ng/mL), T stage (T1c-T2c vs T3a-T3b), combined Gleason score
(2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate
brachytherapy (before external beam radiotherapy vs after external beam radiotherapy).
Patients undergo external beam radiotherapy over approximately 15 minutes once daily 5 days
a week for 5 weeks. Patients also receive two fractions (within a 24-hour period) of
high-dose rate brachytherapy (delivered through an implant inserted into the prostate) over
approximately 5-30 minutes either before or after external beam radiotherapy. Treatment
continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Clinical stage T1c-T3b
- No clinically or pathologically involved lymph nodes (N0 by pelvic CT scan or
MRI)
- No distant metastases (M0 by negative bone scan)
- Meets one of the following combination criteria:
- Clinical stage T1c-T2c, Gleason score 2-6, and prostate-specific antigen (PSA) >
10 but ≤ 20 ng/mL
- Clinical stage T3a-T3b, Gleason score 2-6, and PSA ≤ 20 ng/mL
- Clinical stage T1c-T3b, Gleason score 7-10, and PSA ≤ 20 ng/mL
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Fertile patients must use effective contraception
- No hip prosthesis
- No major medical or psychiatric illness that would preclude study participation
- No prior invasive malignancy except nonmelanomatous skin cancer (e.g., carcinoma in
situ of the oral cavity or bladder) or any other malignancy with a disease-free
status ≥ 3 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for prostate cancer
Endocrine therapy
- Prior induction hormonal therapy allowed provided therapy was initiated within 90
days before study enrollment
Radiotherapy
- No prior pelvic or prostate radiotherapy
- No concurrent intensity-modulated radiotherapy
Surgery
- No prior radical surgery for prostate cancer
- No prior transurethral resection of the prostate
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Late severe genitourinary (GU) and gastrointestinal (GI) toxicity as measured by CTCAE v3.0 more than 9 months after starting treatment
Safety Issue:
Yes
Principal Investigator
I-Chow J. Hsu, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Federal Government
Study ID:
CDR0000382120
NCT ID:
NCT00091390
Start Date:
July 2004
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- Adenocarcinoma
- Prostatic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
| Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough, Maine 04074 |
| Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
| OSF St. Francis Medical Center | Peoria, Illinois 61637 |
| Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital | Inglewood, California 90301 |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
| Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center | Boca Raton, Florida 33486 |
