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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
3/08/2024
Date data sharing statement initially provided
22/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
MRI Guided Stereotactic Focal Ablation of Prostate Cancer
Scientific title
MRI Guided Stereotactic Focal Ablation of Prostate Cancer investigating feasibility, Toxicity and Patient Reported Outcomes.
Secondary ID [1] 310123 0
not applicable
Universal Trial Number (UTN)
Trial acronym
MR Ablate
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 330691 0
Condition category
Condition code
Cancer 327509 327509 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 326524 0
Treatment: Other
Comparator / control treatment
This is a feasibility study, there is no comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335377 0
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
Timepoint [1] 335377 0
The primary time point is when the fraction is being delivered.
Primary outcome [2] 335452 0
Patient reported change in EPIC-26 bowel domain
Timepoint [2] 335452 0
at 24 months and 60 months post Radiation therapy
Primary outcome [3] 335453 0
Biochemical free survival defined as recurrence PSA nadir+2( Which is the Phoenix definition for biochemical recurrence) PSA is determined by a blood test.
Timepoint [3] 335453 0
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
Secondary outcome [1] 424132 0
Treatment related Toxicity assessed by CTCAE Version 5
Timepoint [1] 424132 0
Toxicity will be assessed every 3 months until 1 year post radiation treatment, then 6 monthly until 5 years post radiation treatment.
Secondary outcome [2] 424702 0
In radiation treatment field tumour control based on Radiation therapy treatment plan field and recurrence location on follow-up imaging, MRI, PSMA PET.
Timepoint [2] 424702 0
the secondary outcome above, that is in field control will be assessed at 24 months post radiation treatment.
Secondary outcome [3] 424703 0
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.
Timepoint [3] 424703 0
The secondary outcome above will be assessed by prostate biopsy, PSMA PET and MRI scheduled at 24 months post radiation therapy.
Secondary outcome [4] 424705 0
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
Timepoint [4] 424705 0
at 24 months and 60 months post radiation therapy assessments
Secondary outcome [5] 424959 0
Additional Primary outcome: Change in Urinary domains as assessed by EPIC 26 patient reported outcome questionnaire.
Timepoint [5] 424959 0
Post Radiation Treatment at 24 months and 60 months
Secondary outcome [6] 424960 0
Additional Primary Outcome: Change is sexual domains assessed by EPIC 26 patient reported outcome questionnaire
Timepoint [6] 424960 0
at 24 months and 60 months post radiation Therapy

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
Minimum age
40 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/07/2023
Actual
26/07/2023
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
25
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25172 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 40842 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 314283 0
Hospital
Name [1] 314283 0
Austin Health
Country [1] 314283 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 316227 0
None
Name [1] 316227 0
Address [1] 316227 0
Country [1] 316227 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313402 0
Austin Health
Ethics committee address [1] 313402 0
Ethics committee country [1] 313402 0
Australia
Date submitted for ethics approval [1] 313402 0
31/01/2023
Approval date [1] 313402 0
23/05/2023
Ethics approval number [1] 313402 0
HREC/91693/Austin-2023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128026 0
Mr Gregory Jack
Address 128026 0
Austin Health
145 Studley Road
Heidelberg VIC 3084
Country 128026 0
Australia
Phone 128026 0
+61 3 9496 2800
Fax 128026 0
Email 128026 0
Greg.Jack@austin.org.au
Contact person for public queries
Name 128027 0
Trish Jenkins
Address 128027 0
Austin Health Radiation Oncology
145 Studley Road
Heidelberg VIC 3084
Country 128027 0
Australia
Phone 128027 0
+61 394964301
Fax 128027 0
+61 394969648
Email 128027 0
Trish.Jenkins@austin.org.au
Contact person for scientific queries
Name 128028 0
Trish Jenkins
Address 128028 0
Austin Health Radiation Oncology
145 Studley Road
Heidelberg VIC 3084
Country 128028 0
Australia
Phone 128028 0
+61 394964301
Fax 128028 0
Email 128028 0
Trish.Jenkins@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


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.