Clinical trial NCT03386045: Optimal Prostate Study
Official title: Optimal Prostate Fractionation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 214
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (SBRT) and standard radiotherapy plus 2 fractions of SBRT (BOOSTER)

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 participants will be randomised to have either moderate hypofractionation or standard radiotherapy plus SBRT (BOOSTER). Participants in this group must be able to have MRI, prostate fiducial markers (gold markers)and hydrogel insertion. Fiducial markers will be used to locate the prostate accurately during radiation treatment. Hydrogel is a temporary gel being injected into the space between the prostate and rectum to reduce the dose of radiation received by the rectum to minimise side effects from the treatment.

Group 2: eligible participants will be randomised to have either moderate hypofractionation or SBRT.

Participants will be reviewed for side effects. A Safety Committee will be formed containing multi-disciplinary team members. All serious adverse will be reported to the principal investigator and Human Research Ethics Committee within 24 hours.

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

Primary outcomes:
measure: local control
timeFrame: 12 months post radiotherapy
Secondary outcomes:
measure: Biological failure rate
timeFrame: 3 year and 5 year
measure: late toxicity
timeFrame: more than three months after treatment completion.
measure: Markerless tracking technology
timeFrame: During radiotherapy treatment
measure: Accuracy of the various intrafraction guidance methods
timeFrame: During radiotherapy treatment
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: Northern Sydney Local Health District
name: Andrew Kneebone, MBBS
role: PRINCIPAL_INVESTIGATOR
References: