Optimal Prostate Study

Prostate Cancer Clinical Trial

Official title:

Optimal Prostate Fractionation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03386045
• Other study ID #: OPTIMAL
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2018
• Est. completion date: August 1, 2028

Study information

• Verified date: November 2023
• Source: Royal North Shore Hospital
• Contact: Carol Kwong
• Phone: +61 2 9463 1339
• Email: carolyn.kwong[@]health.nsw.gov.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: August 1, 2028
• Est. primary completion date: August 1, 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Optimal SBRT
Two thirds of the participants in this group will get the SBRT (5 treatments) and one third will get standard treatment (60 Gy in 20 treatments)
• Optimal Booster
Two thirds of the participants in this group will get the two high precision radiotherapy plus 20 doses of standard external beam radiotherapy (ie the "Booster approach|") and one third will get the standard treatment (60 Gy in 20 treatments)

Locations

Country	Name	City	State
Australia	Royal North Shore Hospital	St Leonards	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Royal North Shore Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local control	the rate of local control as determined on PSMA scanning	12 months post radiotherapy
Secondary	Biological failure rate	The rate of biochemical failure defined as Nadir+2.0 biochemical failure defined as Nadir+2.0	3 year and 5 year
Secondary	late toxicity	Late Gastrointestinal and Genitourinary Toxicity (modified RTOG scale)	more than three months after treatment completion.
Secondary	Markerless tracking technology	Markerless tracking algorithms will be assessed for accuracy against marker-based localisation by masking the markers and directly comparing the determined trajectories	During radiotherapy treatment
Secondary	Accuracy of the various intrafraction guidance methods	Accuracy of various intrafraction guidance methods will be determined against triangulation of kilovoltage (kV) and Megavoltage (MV) projections	During radiotherapy treatment