COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001669189
Ethics application status
Approved
Date submitted
19/11/2019
Date registered
28/11/2019
Date last updated
4/12/2019
Date data sharing statement initially provided
28/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical registry of focal low dose rate brachytherapy in men
with biopsy confirmed low-intermediate risk prostate cancer
Scientific title
Clinical registry of focal low dose rate brachytherapy to assess disease free progression and quality of life in men with biopsy confirmed low-intermediate risk prostate cancer.
Secondary ID [1] 299858 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LIBERATE Clinical Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 315260 0
Condition category
Condition code
Cancer 313560 313560 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
60
Target follow-up type
Months
Description of intervention(s) / exposure
mp-MRI (T1/2, DWI, DCE) - Pre-treatment and again at 18 months
TPM biopsy - Pre-treatment and again at 18 months
Assess eligibility criteria - pre-treatment
Review medical history - pre-treatment
Review medications - pre-treatment
Clinical assessment - pre-treatment and every visit up to 5 years
Informed consent - pre-treatment
Focal LDR brachytherapy
Next day post-implant CT/MRI* - one day after LDR
Post-implant dosimetry - one day after LDR
Acute toxicities (CTCAE) - pre-treatment and again 1 day, 6 weeks, and 3 months after treatment
Late toxicities (CTCAE) - 6,9, 12, 18 and 24 months after treatment then every 6 months up to 5 years
questionnaires - pre-treatment, 6 weeks, 6 months, 12, 18 and 24 months then every 6months up to 5 years.

Enrolment is projected to be completed in 25 months after opening (2 patients per month). The follow-up period will be completed at up to 60 months after the last participant has been enrolled.
Intervention code [1] 316114 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322016 0
The rate of 18-month local disease control


Timepoint [1] 322016 0
This endpoint will be assessed at 18 months after LDR brachytherapy seed implantation, or upon biochemical progression, whichever is earlier. Multi-parametric MRI fusion template prostate mapping (TPM) biopsy at this timepoint is standard following focal LDR brachytherapy for PCa.
Primary outcome [2] 322017 0
The rate of 5-year biochemical progression-free survival following focal LDR brachytherapy in men with low to intermediate risk PCa.
Timepoint [2] 322017 0
Serum PSA will be collected and analysed prior to all routine follow-up appointments following treatment. The appointments will be 6 weeks following treatment, then three-monthly for 12 months following treatment, then six-monthly until five years following treatment, or upon withdrawal or pathological or biochemical failure. Serum PSA testing at this frequency is standard of care for men following treatment for PCa.
Secondary outcome [1] 377018 0
Determine the toxicity profile of focal LDR brachytherapy
Timepoint [1] 377018 0
Toxicity will be assessed at both patient enrolment (baseline) and every routine follow-up appointment (scheduled and unscheduled) until the final follow up appointment at five years, withdrawal or upon pathological or biochemical failure (primary endpoints). Assessments will be at 6 weeks post-treatment, three-monthly for 12 months following treatment, then six-monthly until five years post-treatment. Clinical assessment at this frequency is standard of care for men following brachytherapy for PCa.
Secondary outcome [2] 377019 0
Measure the change in patient-reported generic and disease-specific quality of life
Timepoint [2] 377019 0
Change in patient-reported quality of life as measured by the SF-12v2, IPSS, IIEF and EPIC bowel domain at 6 weeks, then 6-monthly post-treatment.

All questionnaires will be completed by patients following written informed consent (baseline) and at pre-defined routine follow up appointments following focal LDR brachytherapy (refer to Section 8) until the final follow up appointment at 60 months, withdrawal or upon pathological or biochemical failure (primary endpoints).
Secondary outcome [3] 377022 0
Determine the rate of 3-year biochemical progression-free survival
Timepoint [3] 377022 0
Serum PSA will be collected and analysed prior to all routine follow-up appointments following treatment. The appointments will be 6 weeks following treatment, then three-monthly for 12 months following treatment, then six-monthly until five years following treatment, or upon withdrawal or pathological or biochemical failure. Serum PSA testing at this frequency is standard of care for men following treatment for PCa.

Eligibility
Key inclusion criteria
• Men 40-85 years of age (inclusive);
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Life expectancy more than 10 years based on co-morbidity not related to prostate cancer.
• Prostate specific antigen (PSA) level less than 10 ng/ml
• Prostate cancer clinical stage T1c or T2a
• Prostate size less than 60cc on multi-parametric MRI (T1W/T2W, diffusion-weighting and dynamic contrast enhancement)
• PIRADS score of 3-5 (inclusive)
• Reproducible template biopsy of the prostate gland demonstrating:
o Histologically-proven index lesion Gleason 6 (=10mm in =1 core) or 7 (3+4) adenocarcinoma coinciding with mp-MRI identified lesion;
o Template biopsies of the remaining gland, with minimum 18 cores taken for <40cc prostate and 24 cores for 40-60cc prostate; and
o Non sector positive prostate containing no cancer or clinically insignificant cancer (cancer core length <10mm Gleason 3+3)
• IPSS score = 15
• Men with an IPSS score of 8 to 15 (inclusive) must have a urinary flow (Qmax = 10ml/sec) and residual volume = 150ml with voided volume >150ml
• Able to participate in the stipulated follow-up (either telephone follow-up or on-site visits acceptable, but one follow-up annually should be in person).
• Patients or their legal representatives must have the ability to read, understand and provide written informed consent (TBC – see informed consent section).
Minimum age
40 Years
Maximum age
85 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Evidence or suspicion of extra-capsular extension on MRI.
• Prostate cancer with significant sarcomatoid, ductal, spindle cell or neuroendocrine small cell components.
• Any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer.
• Any inactive malignancy diagnosed within 5 years of entry, except for non-melanoma skin cancer.
• Any anatomical abnormality or medical condition precluding brachytherapy planning or treatment, or follow-up imaging (i.e. unable to cease anti-coagulant therapy, contraindications to anaesthesia, imperforate anus, TURP defect, diffuse intra-prostatic calcification, unfavourable prostatic geometry etc.)
• Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
• Patients who have received, or are receiving, any form of localised or systemic treatment (including ADT) for prostate carcinoma (excluding 5a-reductase inhibitors).
• Patients who are unwilling or unable to adhere to study requirements, including treatment and required assessments.
• Patients opt-out of participating in the registry in writing

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be reported using frequencies and percentages or proportions for binary or categorical data. Percentages will be calculated based upon the number of patients for whom data are available. Continuous or dimensional variables will be summarised using means and standard deviations, with medians and interquartile ranges (difference between 25th and 75th percentiles) reported for potentially skewed data such as PSA (Murphy et al. 2009) or SF-12 (McKenzie et al. 2015).
The primary endpoints of the proportion of patients exhibiting local control at 18 months (1) and the proportion of patients achieving biochemical progression-free survival at 5 years (2), will be analysed using proportions, and in the case of the latter outcome, a single-group Kaplan-Meier survival curve.
In regard to secondary endpoints, changes in variables such as SF-12v2 over time will assessed using methods appropriate for analysis of longitudinal data, such as mixed models / hierarchical linear modelling or generalised estimating equations (GEE) models appropriate to the scale of data being measured and the sample size. Appropriate graphs of changes over time and simple pairwise comparison between baseline and 6 weeks, then every 6 months up to 5 years or withdrawal will also be presented, with maximum change being expected between baseline and 6 weeks following treatment. If missing or questionable data are identified, the study team will clarify and seek restoration of missing observations. If unable to be identified from source the missing observations will be reported for all endpoints.
95% confidence intervals will be presented throughout, and any tests of statistical significance will employ an alpha of 0.05, two-tailed. All analyses will be conducted using standard professional statistical software, such as Stata (Stata Corporation, College Station, Texas).



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15244 0
Icon Cancer Centre Epworth Freemasons - East Melbourne
Recruitment hospital [2] 15245 0
Icon Cancer Centre Richmond - Richmond
Recruitment postcode(s) [1] 28553 0
3002 - East Melbourne
Recruitment postcode(s) [2] 28554 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 304315 0
Charities/Societies/Foundations
Name [1] 304315 0
Icon Cancer Foundation
Address [1] 304315 0
Level 1, 22 Cordelia St, South Brisbane QLD 4101
Country [1] 304315 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Icon Cancer Foundation
Address
Level 1, 22 Cordelia St, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 304563 0
None
Name [1] 304563 0
none
Address [1] 304563 0
none
Country [1] 304563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304769 0
Bellberry
Ethics committee address [1] 304769 0
123 Glen Osmond Road Eastwood Adelaide
South Australia 5063
Ethics committee country [1] 304769 0
Australia
Date submitted for ethics approval [1] 304769 0
20/09/2019
Approval date [1] 304769 0
20/11/2019
Ethics approval number [1] 304769 0

Summary
Brief summary
This study aims to establish a clinical registry, encompassing patient data from men with prostate cancer undergoing focal LDR brachytherapy.

Who is it for?
You may be eligible for this study if you are man aged between 40 and 85, with a diagnosis of Prostate cancer, clinical stage T1c or T2a.

Study details
The study visits will be 6 weeks following treatment, then three-monthly for 12 months following treatment, then six-monthly until five years following treatment. At these visits, various clinical assessment and blood tests will be performed. In addition, the study will also involve collecting data from MRI scans, biopsies and questionnaires relating to quality of life and functional outcomes, particular in the domains of urinary , gastro-intestinal and sexual function.

It is hoped that the registry can establish an evidence base for the national uptake of focal LDR brachytherapy, in addition to provider greater insight into the global body of data regarding primary focal therapy for PCa.

Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 98142 0
Dr Andrew See
Address 98142 0
Radiation Oncologist
Icon Cancer Centre Richmond
Level 4, 32 Erin Street
Richmond VIC 3121

Country 98142 0
Australia
Phone 98142 0
+61 3 9936 8277
Fax 98142 0
Email 98142 0
Andrew.See@icon.team
Contact person for public queries
Name 98143 0
Ms Lauren Fox
Address 98143 0
Icon Cancer Centre, Level 1, 22 Cordelia street, South Brisbane, QLD, 4101
Country 98143 0
Australia
Phone 98143 0
+61 735177763
Fax 98143 0
Email 98143 0
Lauren.Fox@icon.team
Contact person for scientific queries
Name 98144 0
Dr Andrew See
Address 98144 0
Radiation Oncologist
Icon Cancer Centre Richmond
Level 4, 32 Erin Street
Richmond VIC 3121

Country 98144 0
Australia
Phone 98144 0
+61 3 9936 8277
Fax 98144 0
Email 98144 0
Andrew.See@icon.team

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results