NCT00946543

Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer

A Phase I Dose Escalation Study of the Use of Intensity Modulated Radiotherapy (IMRT) to Treat Prostate and Pelvic Nodes in Patients With Prostate Cancer - Pelvic IMRT for Prostate Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	hypofractionated radiation therapy
RADIATION	intensity-modulated radiation therapy

Timeline

• Start date: 2000-03-01
• Primary completion: 2010-03-01
• First posted: 2009-07-27
• Last updated: 2013-08-26

Locations

3 sites across 1 country: United Kingdom