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

Launched by INSTITUTE OF CANCER RESEARCH, UNITED KINGDOM · Oct 25, 2006

Keywords

ClinConnect Summary

OBJECTIVES:

* Determine the safety and efficacy of conventional vs hypofractionated high-dose intensity-modulated radiotherapy in patients with localized prostate cancer.
* Determine the side effects of these regimens in these patients.
* Determine whether hypofractionated radiotherapy schedules will improve the therapeutic ratio by either improving tumor control or reducing normal tissue side effects.
* Compare acute and late treatment-related gastrointestinal and urological toxicity in these patients.
* Determine different prostate-specific antigen-related endpoints for local failure and...

Gender

MALE

Eligibility 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