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Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Cancer and Leukemia Group B
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: iodine I 125
Drug: leuprolide acetate
Drug: palladium Pd 103
Procedure: brachytherapy
Procedure: neoadjuvant therapy
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

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

U.S. FDA Resources

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

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


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

Publications of Results:
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
First Received:   October 4, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006359
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  

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Leuprolide
Goserelin
Bicalutamide
Iodine
Urogenital Neoplasms
Flutamide
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Fertility Agents, Female
Therapeutic Uses
Fertility Agents

ClinicalTrials.gov processed this record on November 20, 2008




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