NCT01550237

Curative Image Guided Radiotherapy for Prostate Cancer

A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The clinical importance of cone beam computer tomography based image guided radiotherapy (CT- IGRT) has not been established. The primary aim of the present trial is to investigate whether CT- IGRT and consequently reduced safety margins reduces the rectal side effects from curative, high dose radiotherapy in prostate cancer. Any impact of the reduced planning target volume in the CT- IGRT arm on biochemical freedom from disease will be evaluated as secondary outcome. An open randomised phase III trial. The included men will be randomised to receive curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm) or 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm).

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
RADIATION	radiotherapy daily verification reduced safety margins	curative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm)
RADIATION	radiotherapy weekly verification standard safety margins	curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm)

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-09-01
• Completion: 2025-09-01
• First posted: 2012-03-09
• Last updated: 2025-06-05

Locations

2 sites across 1 country: Norway