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”

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue and may improve quality of life and help patients live more comfortably. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and bicalutamide may fight cancer by stopping the production of androgens. It is not yet known whether radiation therapy is more effective with or without goserelin and bicalutamide in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy with or without bicalutamide and goserelin in treating patients who have prostate cancer.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Active Control

OBJECTIVES: - 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. - Compare the prostate-specific antigen relapse-free, distant metastases-free, and overall survival of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the local control in patients treated with these regimens, based on post-treatment sextant biopsies performed 4 years after study completion.

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.

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

Intervention(s) in this Clinical Trial

• Drug: bicalutamide
• Drug: goserelin
• Procedure: adjuvant therapy
• Procedure: management of therapy complications
• Procedure: neoadjuvant therapy
• Procedure: quality-of-life assessment
• Procedure: radiation therapy

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

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

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Memorial Sloan-Kettering Cancer Center

Overall Clinical Trial Officials and Contacts

Michael J. Zelefsky, MD Principal Investigator Memorial Sloan-Kettering Cancer Center  

Information obtained from ClinicalTrials.gov on January 06, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00067015

Study ID Number: CDR0000318807

ClinicalTrials.gov Identifier: NCT00067015

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database