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Trial registered on ANZCTR
Registration number
ACTRN12623000902695
Ethics application status
Approved
Date submitted
13/07/2023
Date registered
22/08/2023
Date last updated
22/08/2023
Date data sharing statement initially provided
22/08/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
MRI Guided Stereotactic Focal Ablation of Prostate Cancer
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Scientific title
MRI Guided Stereotactic Focal Ablation of Prostate Cancer investigating feasibility, Toxicity and Patient Reported Outcomes.
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Secondary ID [1]
310123
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not applicable
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Universal Trial Number (UTN)
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Trial acronym
MR Ablate
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
327509
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study is for patient who have not received prior radiation treatment to the Prostate. The dose of radiation is 26Gray in 2 fractions, given 1 week apart. The treatment will be delivered by a Radiation Oncologist by in the an MRI-guided Linear accelerator (MR-Linac) with continuous MR guidance occurring during radiation treatment. Each treatment will take approximately 60 minutes and PSA and Toxicity toxicity assessments be recorded every 3 months for the first year. then 6 monthly until the 5-year follow-up is completed. MRI’s will be performed annually. At 24 months, a PSMA PET and Prostate biopsy will be performed.
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Intervention code [1]
326524
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Treatment: Other
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Comparator / control treatment
This is a feasibility study, there is no comparator
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Treatment delivery is feasible based on whether each fraction can be delivered within 80 minutes on the treatment table. The feasibility will be assess by measuring the time is takes to deliver the treatment
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Assessment method [1]
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Timepoint [1]
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The primary time point is when the fraction is being delivered.
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Primary outcome [2]
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Patient reported change in EPIC-26 bowel domain
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Assessment method [2]
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Timepoint [2]
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at 24 months and 60 months post Radiation therapy
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Primary outcome [3]
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Biochemical free survival defined as recurrence PSA nadir+2( Which is the Phoenix definition for biochemical recurrence) PSA is determined by a blood test.
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Assessment method [3]
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Timepoint [3]
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PSA will be measured at baseline and then every 3 months until 1 year after treatment then every 6 months until 5 years after treatment
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Secondary outcome [1]
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Treatment related Toxicity assessed by CTCAE Version 5
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Assessment method [1]
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Timepoint [1]
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Toxicity will be assessed every 3 months until 1 year post radiation treatment, then 6 monthly until 5 years post radiation treatment.
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Secondary outcome [2]
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In radiation treatment field tumour control based on Radiation therapy treatment plan field and recurrence location on follow-up imaging, MRI, PSMA PET.
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Assessment method [2]
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Timepoint [2]
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the secondary outcome above, that is in field control will be assessed at 24 months post radiation treatment.
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Secondary outcome [3]
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Local control outside the radiation field based on the radiation field from the planning system and the MRI and PSMA PET scheduled at 24 months post Radiation Therapy.
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Assessment method [3]
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Timepoint [3]
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The secondary outcome above will be assessed by prostate biopsy, PSMA PET and MRI scheduled at 24 months post radiation therapy.
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Secondary outcome [4]
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Metastasis free survival based on MRI, Prostate biopsy and PSMA PET scheduled at the 24 months follow-up. and at the final assessment at 60 months post radiation therapy
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Assessment method [4]
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Timepoint [4]
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at 24 months and 60 months post radiation therapy assessments
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Secondary outcome [5]
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Additional Primary outcome: Change in Urinary domains as assessed by EPIC 26 patient reported outcome questionnaire.
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Assessment method [5]
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Timepoint [5]
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Post Radiation Treatment at 24 months and 60 months
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Secondary outcome [6]
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Additional Primary Outcome: Change is sexual domains assessed by EPIC 26 patient reported outcome questionnaire
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Assessment method [6]
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Timepoint [6]
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at 24 months and 60 months post radiation Therapy
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Eligibility
Key inclusion criteria
Age 40yrs or older; WHO performance status 0-2; Life expectancy at least 10 years; biopsy proven adenocarcinoma of the prostate; low or favourable intermediate risk prostate cancer; PSA less than 20 ng/mL ; Gleason score 7; Clinical T stage cT1c - cT2c. Solitary Tumours not more than 20mm in diameter on MRI; Tumour margins visible on MRI; Prostate Volume less than 100cc on TRUS; willing and able to give written informed consent
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Inability to undergo MRI scanning due to presence of metal or pacemaker or other reason; Clinical Lymph node or distant metastases; Previous treatment for prostate cancer; Previous pelvic radiation therapy; Medications that can affect PSA in the previous 3 months; individuals who are unable to tolerate prolonged stationary supine position up to 1 hour; Urethral stricture; Inflammatory bowel disease; Invasive malignancy within the last 5 years apart from non melanomatous skin cancer; Patients with baseline impotence scoring 17 or below in the SHIM questionnaire; PAtients with Incontinence demonstrated by ICQC-SF score of greater than 5; Active Urinary tract infection and or prostatitis; Prior Trans urethral resection of the prostate within 6 weeks before Radiation therapy; Current participation in another Clinical Investigation; Inability to meet Organs at risk dose constraints
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Analysis will be performed on eligible participants using an intention to treat approach. Time to event analyses will be considered via the development of Kaplan-Meier methods with comparisons made to published outcome for standard treatment. Statistical analyses will be conducted using STATA with 2 sided p-value of less than 0.05 considered to indicate statistical significance.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/09/2023
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Actual
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Date of last participant enrolment
Anticipated
31/12/2025
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Actual
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Date of last data collection
Anticipated
30/06/2026
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
40842
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Austin Health
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Address [1]
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145 Studley Road
Heidelberg VIC 3084
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
145 Studley Road
Heidelberg VIC 3084
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
316227
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Country [1]
316227
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Austin Health
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Ethics committee address [1]
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145 Studley Road
Heidelberg VIC 3084
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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31/01/2023
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Approval date [1]
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23/05/2023
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Ethics approval number [1]
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HREC/91693/Austin-2023
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Summary
Brief summary
This study is investigating the feasibility, safety and effectiveness of delivering targeted radiation therapy using a device with in-built magnetic resonance (MR) imaging to identify and deliver the radiation doses specifically to the prostate tumour.
Who is it for?
You may be eligible for this trial if you are a male aged 40 years or over, you have been diagnosed with a solid prostate tumour that is appropriate for radiation treatment and the cancer has not spread to any other organs. Participants will also need to be able to undergo MR imaging, additional criteria for MR imaging will apply.
Study details
Participants will receive radiation to the prostate gland using a Linear Accelerator device with MR imaging capability. The intervention is intended to be delivered as 2 sessions over 2 weeks. Participants will be asked to provide blood samples to check the PSA level throughout the study to assess the response to treatment. Data on prostate specific antigen (PSA) response to treatment, as well as any changes to the participants' urinary/bowel habits and sexual function will also be collected.
It is hoped that this study will determine whether an MRI-guided approach to radiotherapy is a feasible, safe and effective method for the treatment of prostate cancer that has not spread to other organs.
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Trial website
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Trial related presentations / publications
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Public notes
This study is only available at the Olivia Newton John cancer Wellness and Research Centre but is open to all eligible persons.
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Contacts
Principal investigator
Name
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Mr Gregory Jack
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Address
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Austin Health
145 Studley Road
Heidelberg VIC 3084
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Country
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Australia
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Phone
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+61 3 9496 2800
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Trish Jenkins
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Address
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Austin Health Radiation Oncology
145 Studley Road
Heidelberg VIC 3084
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Country
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Australia
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Phone
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+61 394964301
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Fax
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+61 394969648
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Trish Jenkins
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Address
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Austin Health Radiation Oncology
145 Studley Road
Heidelberg VIC 3084
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Country
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Australia
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Phone
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+61 394964301
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
All data will be kept at Austin Health and as this is a single site study the data will only be shared in a deidentified form in the final publication. Each participant's data may be shared with them in the context of a medical consultation with either their Urologist or Radiation Oncologist. Only deidentified grouped or aggregate data will be published.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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