Status:
RECRUITING
Optimal Prostate Study
Lead Sponsor:
Royal North Shore Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 (SBR...
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 particip...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT03386045
Start Date
October 2 2018
End Date
August 1 2028
Last Update
November 18 2023
Active Locations (1)
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1
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065