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Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
Study NCT00006359   Information provided by National Cancer Institute (NCI)
First Received: October 4, 2000   Last Updated: February 6, 2009   History of Changes

October 4, 2000
February 6, 2009
September 2000
 
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 ]
Grade 3 long-term toxicity assessed by NCI CTC v2.0 and RTOG/EORTC Long-Term Toxicity Criteria at 18 months
Complete list of historical versions of study NCT00006359 on ClinicalTrials.gov Archive Site
Biochemical non-evidence of disease (bNED) at 2 or more years after treatment [ Designated as safety issue: No ]
Biochemical non-evidence of disease (bNED) at 2 or more years after treatment
 
Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer

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.

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.

Phase II
Interventional
Treatment, Open Label
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
 
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]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006359
 
CDR0000068228, CALGB-99809
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Mark Hurwitz, MD Dana-Farber/Brigham and Women's Cancer Center
National Cancer Institute (NCI)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP