Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006359

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: bicalutamide Drug: flutamide Drug: goserelin Drug: leuprolide acetate Procedure: neoadjuvant therapy Radiation: brachytherapy Radiation: iodine I 125 Radiation: palladium Pd 103 Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Flutamide Leuprolide Goserelin Leuprolide acetate Bicalutamide Iodine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Grade 3 long-term toxicity assessed by NCI CTC v2.0 and RTOG/EORTC Long-Term Toxicity Criteria at 18 months [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Biochemical non-evidence of disease (bNED) at 2 or more years after treatment [ Designated as safety issue: No ]

Study Start Date:

September 2000

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
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
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
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
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13057
Community General Hospital of Greater Syracuse
Syracuse, New York, United States, 13215
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157
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
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

National Cancer Institute (NCI)

Investigators

Study Chair:

Mark Hurwitz, MD

Dana-Farber/Brigham and Women's Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Hurwitz MD, Halabi S, Ou SS, McGinnis LS, Keuttel MR, Dibiase SJ, Small EJ. Combination External Beam Radiation and Brachytherapy Boost with Androgen Suppression for Treatment of Intermediate-Risk Prostate Cancer: An Initial Report of Calgb 99809. Int J Radiat Oncol Biol Phys. 2008 Apr 11; [Epub ahead of print]

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.

Study ID Numbers:	CDR0000068228, CALGB-99809
Study First Received:	October 4, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00006359 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Goserelin
Urogenital Neoplasms
Reproductive Control Agents
Genital Diseases, Male
Flutamide

Hormones
Pharmacologic Actions
Androgen Antagonists
Neoplasms
Neoplasms by Site
Leuprolide
Fertility Agents, Female
Therapeutic Uses
Fertility Agents
Bicalutamide
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on November 27, 2009