Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001076066
Ethics application status
Approved
Date submitted
8/07/2010
Date registered
7/12/2010
Date last updated
1/07/2019
Date data sharing statement initially provided
1/07/2019
Date results information initially provided
1/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Repeat prostate evaluation and therapy pilot study in patients undergoing high dose rate brachytherapy for prostate cancer
Scientific title
A pilot study to evaluate tolerance, safety and efficacy of repeated prostate biopsy in patients undergoing high dose rate brachytherapy for prostate cancer
Secondary ID [1] 252182 0
Peter MacCallum Cancer Centre 10-68
Secondary ID [2] 253241 0
PMCC 10/68
Universal Trial Number (UTN)
Trial acronym
RePEAT Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 257721 0
Condition category
Condition code
Cancer 257890 257890 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Repeated prostate biopsies are to be obtained from malignant areas identified on previous transrectal ultrasound biopsy. These will be prior to the first high dose rate (HDR) brachytherapy fractions and at various durations prior to the second HDR dose, and again approximately 30 minutes after that dose (i.e. up to 5 biopsies in total).
Intervention code [1] 256774 0
Treatment: Other
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258755 0
Unacceptable Toxicity Rate - a composite measure of infection (requiring >5 days of antibiotics), patient tolerance (refusal of subsequent biopsy) and grade 3 toxicity (using NCI CTC criteria)
Timepoint [1] 258755 0
6 weeks following intervention completion
Secondary outcome [1] 266472 0
presence of prostate tissue on each biopsy assessed using light microscopy
Timepoint [1] 266472 0
6 weeks following intervention completion

Eligibility
Key inclusion criteria
Patients undergoing high dose rate brachytherapy for prostate cancer
Minimum age
40 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
previous transurethral resection of prostate (TURP), anticoagulation, previous sepsis from prostate biopsy

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2010
Actual
16/11/2010
Date of last participant enrolment
Anticipated
Actual
21/01/2014
Date of last data collection
Anticipated
Actual
21/06/2015
Sample size
Target
13
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 257265 0
Charities/Societies/Foundations
Name [1] 257265 0
Prostate Cancer Foundation of America (PCF)
Country [1] 257265 0
United States of America
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
St Andrews Pl
E Melbourne
VIC 3000
Country
Australia
Secondary sponsor category [1] 256509 0
None
Name [1] 256509 0
NA
Address [1] 256509 0
NA
Country [1] 256509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259285 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 259285 0
St Andrew Pl
E Melbourne
VIC 3000
Ethics committee country [1] 259285 0
Australia
Date submitted for ethics approval [1] 259285 0
06/08/2010
Approval date [1] 259285 0
11/10/2010
Ethics approval number [1] 259285 0
10/68

Summary
Brief summary
a preliminary study of the ability to obtain tissue before and after radiation therapy (using brachytherapy) for the purpose of studying the molecular and cellular response of the cancer.
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 31377 0
Address 31377 0
Country 31377 0
Phone 31377 0
Fax 31377 0
Email 31377 0
Contact person for public queries
Name 14624 0
Scott Williams
Address 14624 0
Peter MacCallum Cancer Centre
St Andrews Place
E Melbourne
VIC 3000
Country 14624 0
Australia
Phone 14624 0
+61 3 9656 1111
Fax 14624 0
+61 3 9656 1424
Email 14624 0
[email protected]
Contact person for scientific queries
Name 5552 0
Scott Williams
Address 5552 0
Peter MacCallum Cancer Centre
St Andrews Place
E Melbourne
VIC 3000
Country 5552 0
Australia
Phone 5552 0
+61 3 9656 1111
Fax 5552 0
+61 3 9656 1424
Email 5552 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.