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Clinical Trials in Australia / NCT03386045
Active, not recruiting Not applicable

Optimal Prostate Study

NCT03386045 · tracked via the Priya Life Science Australia tracker
Sponsor
Royal North Shore Hospital
Phase
Not applicable
Started
2018-10-02
Last updated
2026-01-29

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Optimal SBRTOptimal Booster

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)

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)

Study 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)

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • local control — 12 months post radiotherapy
    the rate of local control as determined on PSMA scanning

Trial sites (1)

FacilityCityRegionStatus
Royal North Shore Hospital St Leonards New South Wales

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03386045 on ClinicalTrials.gov ↗ ← All trials in Australia