Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	CALGB-99809 NCT00006359

Objectives

1. 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.
2. Determine the safety of EBRT+BT in these patients.
3. 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.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic:

• Bilirubin ≤ 1.5 times upper limit of normal

Renal:

• Not specified

Other:

• Fertile patients must use effective contraception

Expected Enrollment

A total of 60 patients will be accrued for this study.

Outcomes

Grade 3 long-term toxicity assessed by NCI CTC v2.0 and RTOG/EORTC Long-Term Toxicity Criteria at 18 months

Biochemical non-evidence of disease (bNED) at 2 or more years after treatment

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.

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 99809. Int J Radiat Oncol Biol Phys 72 (3): 814-9, 2008.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Mark Hurwitz, MD, Protocol chair		Ph: 617-732-7936; 800-638-6294 Email: mhurwitz@lroc.harvard.edu

Registry Information
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
Trial Start Date		2000-09-15
Registered in ClinicalTrials.gov		NCT00006359
Date Submitted to PDQ		2000-08-23
Information Last Verified		2005-11-21
NCI Grant/Contract Number		CA31946

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