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

Alternate Title

Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Closed 18 and over NCI MSKCC-03040 NCT00067015

Objectives

1. Compare the quality of life of patients with high-grade intermediate-risk or unfavorable-risk adenocarcinoma of the prostate when treated with high-dose intensity-modulated radiotherapy alone versus with androgen deprivation comprising bicalutamide and goserelin.
2. Compare the prostate-specific antigen relapse-free, distant metastases-free, and overall survival of patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.
4. Compare the local control in patients treated with these regimens, based on post-treatment sextant biopsies performed 4 years after study completion.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the prostate



• Unfavorable-risk disease, including at least 2 of the following characteristics:
  • Prostate-specific antigen level greater than 10 ng/mL
  • Gleason score greater than 7
  • Stage T4



• Intermediate-risk disease with a Gleason score of at least 8 allowed



• Lymph nodes clinically negative by imaging studies or histologically negative by node sampling or lymph node dissection



• Prostate size less than 75 grams



• No distant metastases by bone scan, CT scan, or MRI

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for prostate cancer

Endocrine therapy

• No prior androgen-deprivation therapy

Radiotherapy

• No prior pelvic radiotherapy
• No prior prostate brachytherapy

Surgery

• No prior bilateral orchiectomy
• No prior radical prostatectomy
• No prior cryotherapy for prostate cancer

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 80-100%

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT and SGPT no greater than 1.5 times ULN

Renal

• Not specified

Other

• No documented history of inflammatory bowel disease
• No bilateral hip replacements
• No other invasive cancer except localized basal cell or squamous cell skin cancer unless disease free for at least 5 years
• No major medical or psychiatric illness that would preclude study completion, compliance, or follow-up

Expected Enrollment

A total of 400 patients (200 per treatment arm) will be accrued for this study within 4-5 years.

Outline

This is a randomized study. Patients are stratified according to prostate-specific antigen level, Gleason score, and clinical stage. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo high-dose intensity-modulated radiotherapy (IMRT) 4-5 times per week for 10 weeks (a total of 48 treatments).



• Arm II: Patients receive oral bicalutamide once daily for 18.5 weeks. Three to seven days after the initiation of bicalutamide, patients also receive goserelin subcutaneously monthly for 2 years. Beginning after 10 weeks of hormonal therapy, patients undergo concurrent high-dose IMRT 4-5 times per week for 8.5 weeks (a total of 42 treatments). Patients discontinue bicalutamide on or near the end of radiotherapy.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 3 months for 1.5 years after the completion of radiotherapy, then 6 months later, and then annually for 2 years.

Patients are followed every 6-8 months for 4 years and then annually for 2 years.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Michael Zelefsky, MD, Principal investigator		Ph: 212-639-6802; 800-525-2225

Registry Information
Official Title		Phase III Randomized Trial Study Comparing the Outcome of High-Dose IMRT (86.4 GY) Alone with IMRT to 75.6 GY Plus Neoadjuvant/Adjuvant Androgen Deprivation in Patients with High Grade Intermediate Risk and Unfavorable Risk Prostate Cancer
Trial Start Date		2003-05-13
Registered in ClinicalTrials.gov		NCT00067015
Date Submitted to PDQ		2003-07-01
Information Last Verified		2004-11-08
NCI Grant/Contract Number		R01-CA59017, P30-CA08748

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