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Search / Trial NCT03386045

Optimal Prostate Study

Launched by ROYAL NORTH SHORE HOSPITAL · Dec 20, 2017

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

ClinConnect Summary

The Optimal Prostate Study is a clinical trial designed to compare three different types of radiotherapy for men with prostate cancer. The goal is to find out which method has the least side effects, how well it controls the cancer locally, the chances of cancer returning, and how it affects the quality of life for patients. The three methods being compared are moderate hypofractionation, stereotactic body radiotherapy (SBRT), and a combination of standard radiotherapy with two additional SBRT treatments.

To participate in this trial, men aged 65 to 74 who have been diagnosed with prostate cancer and meet certain health requirements can apply. Key factors for eligibility include having a recent prostate-specific antigen (PSA) test result, being able to understand and agree to the study, and being suitable for high-dose radiation treatment. Participants can expect to receive one of the radiotherapy techniques and will be monitored for their health and quality of life throughout the study. It's important to know that certain conditions, like having had previous pelvic radiation therapy or prostate surgery, may prevent someone from joining the trial.

Gender

MALE

Eligibility criteria

  • 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

About Royal North Shore Hospital

Royal North Shore Hospital, a leading tertiary healthcare facility located in Sydney, Australia, is at the forefront of clinical research and innovation. As a key sponsor of clinical trials, the hospital is dedicated to advancing medical knowledge and improving patient outcomes through rigorous scientific investigation. With a multidisciplinary team of experienced researchers and healthcare professionals, Royal North Shore Hospital collaborates with various stakeholders to conduct ethically sound and scientifically robust studies across a range of therapeutic areas. The hospital's commitment to excellence in patient care and research ensures that it remains a pivotal institution in the landscape of clinical trials.

Locations

St Leonards, New South Wales, Australia

Patients applied

0 patients applied

Trial Officials

Andrew Kneebone, MBBS

Principal Investigator

Northern Sydney Local Health District

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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