NCT01584258

Prostate Advances in Comparative Evidence

International Randomised Study of Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Organ-Confined Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,205 (actual)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Prostatectomy	Radical prostatectomy: performed open, laparoscopically or using a robotically assisted laparoscopic approach.
RADIATION	Conventionally Fractionated Prostate Radiotherapy	Conventional fractionation delivered to a dose of: (PACE-B) 78 Gy in 39 fractions or 62 Gy in 20 fractions; (PACE-C) 60 Gy in 20 fractions
RADIATION	Prostate SBRT	Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.

Timeline

• Start date: 2012-08-07
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2012-04-24
• Last updated: 2024-01-19

Locations

68 sites across 4 countries: Canada, Ireland, New Zealand, United Kingdom