Optimal Prostate Study

November 14, 2023 updated by: Royal North Shore Hospital

Optimal Prostate Fractionation Study

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Histologically proven prostate adenocarcinoma
  • PSA obtained within three months prior to enrolment
  • ECOG performance status 0 to 2
  • Ability to understand and the willingness to sign a written consent
  • Suitable for high dose irradiation to the prostate

To be eligible for the arm containing Stereotactic Booster alone approach patient must have the following

  • No contraindication to MRI such as pacemaker and severe claustrophobia
  • Patient must be able to have fiducial markers placed in the prostate
  • Patient must be able to have hydrogel insertion at the same time as fiducial markers
  • Must have IPSS less than 15

Exclusion criteria

  • Previous pelvic radiotherapy
  • Prior total prostatectomy
  • Unwilling or unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Optimal SBRT
Participants in this group will be randomised to either SBRT ( 36 to 45 GY in 5 fractions) or standard radiotherapy (60 Gy in 20 fractions). The allocation is 2 to 1. This means that two thirds of the participants on the trial will get the SBRT (5 treatments) and one third will get the standard fractions.
Radiation: Optimal SBRT
Two thirds of the participants in this group will get the SBRT (5 treatments) and one third will get standard treatment (60 Gy in 20 treatments)
Active Comparator: Optimal Booster
Participants in this group will be randomised to either standard radiotherapy plus SBRT (45 Gy in 20 fractions plus 20-30 Gy in 2 fractions-Booster) or standard radiotherapy (60 Gy in 20 fractions). The allocation is 2 to 1. This means that two thirds of the participants on the trial will get the Booster arm and one third will get the standard fractions.
Radiation: Optimal Booster
Two thirds of the participants in this group will get the two high precision radiotherapy plus 20 doses of standard external beam radiotherapy (ie the "Booster approach|") and one third will get the standard treatment (60 Gy in 20 treatments)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local control
Time Frame: 12 months post radiotherapy
the rate of local control as determined on PSMA scanning
12 months post radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological failure rate
Time Frame: 3 year and 5 year
The rate of biochemical failure defined as Nadir+2.0 biochemical failure defined as Nadir+2.0
3 year and 5 year
late toxicity
Time Frame: more than three months after treatment completion.
Late Gastrointestinal and Genitourinary Toxicity (modified RTOG scale)
more than three months after treatment completion.
Markerless tracking technology
Time Frame: 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
During radiotherapy treatment
Accuracy of the various intrafraction guidance methods
Time Frame: During radiotherapy treatment
Accuracy of various intrafraction guidance methods will be determined against triangulation of kilovoltage (kV) and Megavoltage (MV) projections
During radiotherapy treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal North Shore Hospital

Investigators

  • Principal Investigator: Andrew Kneebone, MBBS, Northern Sydney Local Health District

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2018

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 29, 2017

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTIMAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

aim to present study data in conferences and medical journals

IPD Sharing Time Frame

end of trial after analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Optimal SBRT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe