Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Cancer and Leukemia Group B.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Cancer and Leukemia Group B
Collaborator:
Information provided by:
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00006359
First received: October 4, 2000
Last updated: April 11, 2011
Last verified: April 2011
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Purpose
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: LHRH agonist Drug: antiandrogen Radiation: radiation therapy Radiation: Brachytherapy boost |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Cancer and Leukemia Group B:
Primary Outcome Measures:
- Toxicity [ Time Frame: q 3 mon for 2 yrs post tx initiation ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Time to PSA failure [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]Progression free and overall survival will be assessed
| Enrollment: | 63 |
| Study Start Date: | September 2000 |
| Estimated Study Completion Date: | March 2012 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Androgen suppression + EBRT + Brachytherapy
Androgen suppression with external beam radiation therapy followed by brachytherapy boost
|
Drug: LHRH agonist
Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2
Drug: antiandrogen
flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks
Radiation: radiation therapy
4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)
Radiation: Brachytherapy boost
Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006359
Locations
| United States, Delaware | |
| Beebe Medical Center | |
| Lewes, Delaware, United States, 19958 | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19718 | |
| St. Francis Hospital | |
| Wilmington, Delaware, United States, 19805 | |
| United States, Florida | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803 | |
| United States, Maryland | |
| Union Hospital Cancer Center at Union Hospital | |
| Elkton MD, Maryland, United States, 21921 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Hudner Oncology Center at Saint Anne's Hospital | |
| Fall River, Massachusetts, United States, 02721 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Arch Medical Services, Incoroporated at Center for Cancer Care Research | |
| Saint Louis, Missouri, United States, 63141 | |
| Missouri Baptist Cancer Center | |
| St. Louis, Missouri, United States, 63131 | |
| United States, Nevada | |
| Washoe Cancer Services at Washoe Medical Center - Reno | |
| Reno, Nevada, United States, 89502 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | |
| Camden, New Jersey, United States, 08103 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13057 | |
| Veterans Affairs Medical Center - Syracuse | |
| Syracuse, New York, United States, 13210 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| Community General Hospital of Greater Syracuse | |
| Syracuse, New York, United States, 13215 | |
| United States, North Carolina | |
| Presbyterian Cancer Center at Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233 | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| Zimmer Cancer Center at New Hanover Regional Medical Center | |
| Wilmington, North Carolina, United States, 28401 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Virginia | |
| Danville Regional Medical Center | |
| Danville, Virginia, United States, 24541 | |
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
| Study Chair: | Mark Hurwitz, MD | Dana-Farber/Brigham and Women's Cancer Center |
More Information
Additional Information:
Publications:
Hurwitz MD, Halabi S, Archer L, et al.: Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: long-term results of CALGB 99809. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-192, 2010.
Hurwitz MD, Halabi S, Ou SS, et al.: Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate risk prostate cancer: an initial report of CALGB 99-809. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2230, S337-8, 2006.
| Responsible Party: | Monica M Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00006359 History of Changes |
| Other Study ID Numbers: | CDR0000068228, U10CA031946, CALGB-99809 |
| Study First Received: | October 4, 2000 |
| Last Updated: | April 11, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Cancer and Leukemia Group B:
|
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Androgen Antagonists Androgens Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Hormones |
ClinicalTrials.gov processed this record on May 19, 2013