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Trial record 1 of 1 for:    NCT03386045
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Optimal Prostate Study

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ClinicalTrials.gov Identifier: NCT03386045
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Royal North Shore Hospital

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)

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Optimal SBRT Radiation: Optimal Booster Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Treatment
Official Title: Optimal Prostate Fractionation Study
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : March 28, 2026
Estimated Study Completion Date : March 28, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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)

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.
Radiation: 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)




Primary Outcome Measures :
  1. local control [ Time Frame: 12 months post radiotherapy ]
    the rate of local control as determined on PSMA scanning


Secondary Outcome Measures :
  1. Biological failure rate [ Time Frame: 3 year and 5 year ]
    The rate of biochemical failure defined as Nadir+2.0 biochemical failure defined as Nadir+2.0

  2. late toxicity [ Time Frame: more than three months after treatment completion. ]
    Late Gastrointestinal and Genitourinary Toxicity (modified RTOG scale)

  3. Markerless tracking technology [ Time Frame: During radiotherapy treatment ]
    Markerless tracking algorithms will be assessed for accuracy against marker-based localisation by masking the markers and directly comparing the determined trajectories

  4. Accuracy of the various intrafraction guidance methods [ Time Frame: During radiotherapy treatment ]
    Accuracy of various intrafraction guidance methods will be determined against triangulation of kilovoltage (kV) and Megavoltage (MV) projections



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386045


Contacts
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Contact: Carol Kwong +61 2 9463 1339 carolyn.kwong@health.nsw.gov.au
Contact: Clare Banks +61 2 9463 1345 clare.banks@health.nsw.gov.au

Locations
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Australia, New South Wales
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2065
Contact: Carol Kwong, RN    +6129463 1339    carolyn.kwong@health.nsw.gov.au   
Contact: Clare Banks, B.Sc(HIM)MPH    +6129463 1345    clare.banks@health.nsw.gov.au   
Principal Investigator: Andrew Kneebone, MBBS         
Sponsors and Collaborators
Royal North Shore Hospital
Investigators
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Principal Investigator: Andrew Kneebone, MBBS Northern Sydney Local Health District
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Responsible Party: Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT03386045    
Other Study ID Numbers: OPTIMAL
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: aim to present study data in conferences and medical journals
Time Frame: end of trial after analysis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases