Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer

Royal Marsden NHS Foundation Trust198 enrolled

Overview

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. PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.

OBJECTIVES: * To test the feasibility of delivering hypofractionated intensity-modulated radiotherapy to the prostate and pelvic nodes of patients with prostate cancer. * To determine the optimal dose level of this treatment regimen to be used in future studies. OUTLINE: Patients are stratified according to small bowel total volume (low small bowel volume \< 450 cc vs high small bowel volume ≥ 450 cc). Patients undergo hypofractionated intensity-modulated radiotherapy to the prostate and pelvis for 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

198

Conditions

Prostate Cancer

Interventions

hypofractionated radiation therapyRADIATION

intensity-modulated radiation therapyRADIATION

Eligibility

Sex: MALE

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of prostate cancer meeting 1 of the following criteria: * Stage T3b/T4 disease or radiological or pathological pelvic nodal metastases * Localized disease (stage pT2-T4) with \> 30% estimated risk of pelvic nodal metastases * High-risk (Gleason score ≥ 8 or ≥ 2 risk factors) or very high-risk disease according to the National Collaborative Cancer Network (NCCN) * Has undergone prostatectomy AND has stage T2-T3a, N0 disease with extensive high-risk disease (Gleason score ≥ 8) or seminal vesicle or lymph node involvement * Candidate for radical radiotherapy PATIENT CHARACTERISTICS: * No inflammatory bowel disease or other small bowel disease PRIOR CONCURRENT THERAPY: * No prior pelvic radiotherapy or surgery (excluding prostatectomy)

Locations (3)

Institute of Cancer Research - Chelsea

London, England, United Kingdom

RECRUITING

Institute of Cancer Research - Sutton

Sutton, England, United Kingdom

RECRUITING

Royal Marsden - Surrey

Sutton, England, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter

Secondary Outcomes

Overall survival

Local control

PSA control

Acute side effects as assessed weekly by the RTOG scoring system

Quality of life

Patterns of recurrence

Data from ClinicalTrials.gov

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