Intensity-Modulated Radiation Therapy in Treating Patients With Localized Prostate Cancer

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 2163
• Participant gender: Male

Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which schedule of intensity-modulated radiation therapy is more effective in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying the side effects of three schedules of intensity-modulated radiation therapy and compares how well they work in treating patients with localized prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cancer Research, United Kingdom
• Treatments: Cyproterone; Cyproterone Acetate; Hormones
• Last Updated: 2011-05-19

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria:

• Clinical stage T1b-T3a, N0, M0

• Locally confined disease

• Previously untreated disease

• Prostate-specific antigen (PSA) ≤ 30 ng/mL

• Estimated risk of seminal vesicle involvement < 30%

• Estimated risk of seminal vesicle involvement is defined as PSA + ([Gleason score - 6] x 10) (i.e., if Gleason score ≤ 6, then PSA must be ≤ 30 ng/mL; if Gleason score = 7, then PSA must be < 20 ng/mL; if Gleason score = 8, then PSA must be < 10 ng/mL; if Gleason score = 9 or 10 patient is ineligible)

PATIENT CHARACTERISTICS:

• WHO performance status 0 or 1

• Life expectancy > 10 years (5 years for patients with poorly differentiated cancers)

• WBC > 4,000/mm^3

• Hemoglobin > 11g/dL

• Platelet count > 100,000/mm^3

• No other active malignancy within the past 5 years except basal cell carcinoma

• No hip prosthesis or fixation that would interfere with standard radiation beam configuration

• No comorbid conditions likely to impact on the advisability of radical radiotherapy (e.g., previous inflammatory bowel disease, previous colorectal surgery, significant bladder instability, or urinary incontinence)

PRIOR CONCURRENT THERAPY:

• No prior pelvic radiotherapy

• No prior radical prostatectomy

• No prior androgen-deprivation therapy

• No concurrent full anticoagulation therapy with warfarin or heparin