NCT02313298

Stereotactic Body Radiotherapy for Organ Confined Prostate Cancer

A Phase II Trial of Prostate Stereotactic Radiotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

A single arm phase II study of SBRT for prostate cancer to primarily assess acute and late toxicity and secondarily PSA outcomes and quality of life measurements of an extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days.

Detailed description

This is a single arm phase II study of SBRT for prostate cancer to primarily assess acute and late toxicity and secondarily PSA outcomes and quality of life measurements of an extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days. The radiation therapy is to be delivered using intensity modulated radiotherapy (IMRT) with the aid of volumetric image guidance to ensure accuracy. Toxicity will be measured at preset intervals, as will HRQOL parameters using the Expanded Prostate Index Composite (EPIC) questionaire which focuses on bowel, urinary, sexual and hormonal symptoms.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiotherapy	IMRT or similar techniques that use inverse treatment planning

Timeline

• Start date: 2013-06-01
• Primary completion: 2018-12-01
• Completion: 2021-12-01
• First posted: 2014-12-10
• Last updated: 2018-03-29

Locations

1 site across 1 country: Singapore