Optimal Prostate Fractionation Study

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Royal North Shore Hospital
RECRUITING
St Leonards
Contact Information
Primary
Carol Kwong
carolyn.kwong@health.nsw.gov.au
+61 2 9463 1339
Backup
Heidi Tsang
heidi.tsang@health.nsw.gov.au
+61294631340
Time Frame
Start Date: 2018-10-02
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 214
Treatments
Active_comparator: Optimal SBRT
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.
Active_comparator: Optimal Booster
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.
Related Therapeutic Areas
Sponsors
Leads: Royal North Shore Hospital

This content was sourced from clinicaltrials.gov