Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer
OBJECTIVES:
- Determine the feasibility of androgen-suppression therapy combined with external-beam
radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk
localized prostate cancer.
- Determine the safety of EBRT+BT in these patients.
- Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local
recurrence at 5 years, time to prostate-specific antigen failure, and time to first
rectal/bladder injury, in these patients.
OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once
every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three
times daily or oral bicalutamide once daily for 4 weeks.
Within 4 weeks after initiation of androgen-suppression therapy, patients undergo
external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after
completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with
implanted iodine I 125 or palladium Pd 103 seeds.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Must have one of the following prognostic factors:
- Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason
score > 6
- Stage T1-2, N0; PSA > 10 ng/mL and < 20 ng/mL; and Gleason score ≤ 6
- Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6
- Prostate volume < 60 cc by transrectal ultrasound
- No distant or nodal metastases
- No metastatic disease by bone scan, CT scan, or MRI
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic:
- Bilirubin ≤ 1.5 times upper limit of normal
Renal:
- Not specified
Other:
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy for prostate cancer
Chemotherapy:
- No prior chemotherapy for prostate cancer
Endocrine therapy:
- Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated
within 4 weeks of study radiotherapy
- No other prior hormonal therapy
Radiotherapy:
- No prior radiotherapy for prostate cancer
Surgery:
- No prior surgery for prostate cancer
- No prior transurethral resection of the prostate
Other:
- No prior alternative therapy (e.g., PC-SPES) for prostate cancer
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity
Outcome Time Frame:
q 3 mon for 2 yrs post tx initiation
Safety Issue:
Yes
Principal Investigator
Mark Hurwitz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Dana-Farber/Brigham and Women's Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068228
NCT ID:
NCT00006359
Start Date:
September 2000
Completion Date:
March 2012
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage II prostate cancer
- stage III prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Camden, New Jersey 08103 |
| Beebe Medical Center | Lewes, Delaware 19958 |
| St. Francis Hospital | Wilmington, Delaware 19805 |
| Union Hospital Cancer Center at Union Hospital | Elkton MD, Maryland 21921 |
| Community General Hospital of Greater Syracuse | Syracuse, New York 13215 |
| Danville Regional Medical Center | Danville, Virginia 24541 |
| Hudner Oncology Center at Saint Anne's Hospital | Fall River, Massachusetts 02721 |
| Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
| Washoe Cancer Services at Washoe Medical Center - Reno | Reno, Nevada 89502 |
| Arch Medical Services, Incoroporated at Center for Cancer Care Research | Saint Louis, Missouri 63141 |
