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NCT03386045Active, not recruiting

Optimal Prostate Study

Optimal Prostate Fractionation Study

Source: ClinicalTrials.gov · Last updated 29 Jan 2026

Brief summary (registry, in English)

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)

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
503 (actual)
First submitted
11 Dec 2017
Start date
2 Oct 2018
Primary completion date
1 Aug 2028
Lead sponsor
Royal North Shore Hospital
NCT number
NCT03386045

What you commit to

  • Study type: Interventional
  • Participants enrolled: 503
  • From 2 Oct 2018 to the primary completion date, 1 Aug 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous pelvic radiotherapy
  • Prior total prostatectomy

Other

  • Unwilling or unable to give informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal North Shore Hospital
Coordinator of this site? Confirm its status
St LeonardsAustraliaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.