Optimal Prostate Study

Prostate Cancer Clinical Trial

Official title: Optimal Prostate Fractionation Study

Status Recruiting

Clinical Trial Summary

To compare the toxicity, rate of local control, biochemical failure rate and quality of life of three different radiotherapy techniques (moderate hypofractionation, stereotactic body radiotherapy (SBRT) and standard radiotherapy plus 2 fractions of SBRT (BOOSTER)

Clinical Trial Description

Participants must have histologically proven prostate adenocarcinoma, good performance status and suitable for high dose radiotherapy. There are two groups of participants: Group 1: eligible participants will be randomised to have either moderate hypofractionation or standard radiotherapy plus SBRT (BOOSTER). Participants in this group must be able to have MRI, prostate fiducial markers (gold markers)and hydrogel insertion. Fiducial markers will be used to locate the prostate accurately during radiation treatment. Hydrogel is a temporary gel being injected into the space between the prostate and rectum to reduce the dose of radiation received by the rectum to minimise side effects from the treatment. Group 2: eligible participants will be randomised to have either moderate hypofractionation or SBRT. Participants will be reviewed for side effects. A Safety Committee will be formed containing multi-disciplinary team members. All serious adverse will be reported to the principal investigator and Human Research Ethics Committee within 24 hours. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT03386045
• Study type: Interventional
• Source: Royal North Shore Hospital
• Contact: Carol Kwong
• Phone: +61 2 9463 1339
• Email: carolyn.kwong@health.nsw.gov.au
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2018
• Completion date: August 1, 2028