Optimal Prostate Study

Not Applicable

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT03386045
• Lead Sponsor: Royal North Shore Hospital

Brief 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)

Detailed 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.

Study Timeline

• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-29
• Study Start: 2018-10-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18
• Primary Completion: 2028-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 214

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
local control	12 months post radiotherapy	the rate of local control as determined on PSMA scanning

Secondary Outcome Measures

Name	Time	Method
Accuracy of the various intrafraction guidance methods	During radiotherapy treatment	Accuracy of various intrafraction guidance methods will be determined against triangulation of kilovoltage (kV) and Megavoltage (MV) projections
late toxicity	more than three months after treatment completion.	Late Gastrointestinal and Genitourinary Toxicity (modified RTOG scale)
Biological failure rate	3 year and 5 year	The rate of biochemical failure defined as Nadir+2.0 biochemical failure defined as Nadir+2.0
Markerless tracking technology	During radiotherapy treatment	Markerless tracking algorithms will be assessed for accuracy against marker-based localisation by masking the markers and directly comparing the determined trajectories

Trial Locations

Locations (1)

Royal North Shore Hospital; 🇦🇺 St Leonards, New South Wales, Australia