NCT03386045

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)

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
503

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
27mo left

Started Oct 2018

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2018Aug 2028

First Submitted

Initial submission to the registry

December 11, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

October 2, 2018

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

9.8 years

First QC Date

December 11, 2017

Last Update Submit

January 27, 2026

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • local control

    the rate of local control as determined on PSMA scanning

    12 months post radiotherapy

Secondary Outcomes (4)

  • Biological failure rate

    3 year and 5 year

  • late toxicity

    more than three months after treatment completion.

  • Markerless tracking technology

    During radiotherapy treatment

  • Accuracy of the various intrafraction guidance methods

    During radiotherapy treatment

Study Arms (2)

Optimal SBRT

ACTIVE COMPARATOR

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

Optimal Booster

ACTIVE COMPARATOR

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

Interventions

Optimal SBRTRADIATION

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)

Optimal SBRT
Optimal BoosterRADIATION

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)

Optimal Booster

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Andrew Kneebone, MBBS

    Northern Sydney Local Health District

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
no masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 29, 2017

Study Start

October 2, 2018

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

aim to present study data in conferences and medical journals

Time Frame
end of trial after analysis

Locations

AU(1)