Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000524897
Ethics application status
Not yet submitted
Date submitted
1/05/2012
Date registered
17/05/2012
Date last updated
17/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Trial of Polyethylene Glycol (PEG) Hydrogel to Reduce Rectal Radiation Dose During Radiotherapy for Prostate Cancer
Scientific title
Feasibility of Using Polyethylene Glycol Hydrogel to Increase Prostate-Rectum Separation and Its Impact on Rectal Dose During Radiation Therapy
Secondary ID [1] 280498 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectal toxicity during prostate radiotherapy (brachytherapy and/or external beam radiotherapy) 286181 0
Condition category
Condition code
Cancer 286375 286375 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single transperineal injection of polyethylene glycol (10-15ml) in the space posterior to Denonvillier's fascia, and anterior to the rectum, under general anaesthetic. Measurement of prostate-rectum separation, and rectal radiation dose in the presence of the polyethylene glycol spacer. There are four patients groups who wo will be considered for the study (2 prostate seed brachytherapy groups, a high dose rate brachytherapy group, and an external beam radiotherapy group). All four patient groups will receive the same intervention as part of te study (PEG hydrogel insertion and measurement of prostate-rectum separation and rectal radiation dose). The type of radiotherapy they receive will be tailored to their disease and own circumstances and is independent of their participation in the study.
Intervention code [1] 284566 0
Treatment: Devices
Intervention code [2] 284862 0
Treatment: Other
Intervention code [3] 284863 0
Treatment: Drugs
Comparator / control treatment
Historical controls from prostate cancer database from 2005-2010, as well as dose comparison in seed brachytherapy patients before and after spacer injection (the rectal dose before spacer will be different for each patient, but an acceptable rectal radiation dose is less than 2 cubic centimetres of rectum should receive the prescribed radiation dose of 145 Gray).
Control group
Historical

Outcomes
Primary outcome [1] 286830 0
Feasibility of PEG Hydrogel in increasing prostate-Rectum separation and improving rectal dosimetry in prostate brachytherapy and/or external beam radiotherapy patients. Rectal radiation dose data will be collected from radiotherapy planning software used to plan the patients' radiation treatment, and recorded onto paper forms.
Timepoint [1] 286830 0
Once after patient has undergone radiotherapy planning, and again 4 weeks after spacer insertion (not continuous).
Primary outcome [2] 286831 0
Safety of transperineal PEG Hydrogel injection. Clinician assessment of rectal, urinary, or other toxicity associated with the procedure will be undertaken on day 0-1 and at 4-6 weeks using CTCAE v4.0 and recorded onto paper forms.
Timepoint [2] 286831 0
Day 0-1, 4-6 weeks (once only at each of these timepoints).
Secondary outcome [1] 296761 0
Rectal toxicity following prostate brachytherapy and/or external beam radiotherapy in the setting of PEG hydrogel. Clinician assessment of rectal, urinary, or other toxicity associated with the procedure will be undertaken on day 0-1 and at 4-6 weeks using CTCAE v4.0 and recorded onto paper forms.
Timepoint [1] 296761 0
day 0-1, 4-6 weeks (once only at each of these timepoints)
Secondary outcome [2] 296762 0
Stability of PEG Hydrogel and durability of prostate-rectum separation. A CT will be undertaken to measure prostate-rectum separation 4-6 weeks after spacer insertion.
Timepoint [2] 296762 0
4-6 weeks (once only at this timepoint)
Secondary outcome [3] 296763 0
Quality of life following prostate brachytherapy and/or external beam radiotherapy in the setting of PEG hydrogel. This will be assessed with baseline, 4-6 week, 6 and twelve month patient self-administered questionnaires (EORTC QLQC30 and PR25 and the Expanded Prostate Cancer Index Composite Bowel Assessment).
Timepoint [3] 296763 0
baseline, 4-6 weeks, 6 months, and 12 months (once only at each of these timepoints)

Eligibility
Key inclusion criteria
Histopathologically confirmed, localised prostate cancer, fit for prostate brachytherapy or dose escalated external beam radiotherapy with iducial marker localisation, fit for general anaesthetic. No prior history of bleeding disorder, prior transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP), bladder neck resection, perirectal/perianal abscess, rectal/anal fissure. No prior history of prostate or pelvic radiotherapy. Able to provide written informed consent.
Minimum age
50 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Previous history of bleeding disorder, prior TURP, TUIP, bladder neck resection, perirectal/perianal abscess, rectal/anal fissure. Prior history of prostate or pelvic radiotherapy. Unfit for general anaesthetic. Unable to provide written informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a single arm study. Patients who are referred for consideration of prostate brachytherapy and or external beam radiotherapy who satisfy the study's eligibility criteria will be approached for recruitment. Allocation concealment will not be undertaken.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
non-randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Patients will be allocated to 4 subgroups based on the type of prostate radiotherapy they will be undergoing (high dose rate brachytherapy group, 2 seed brachytherapy groups, and 1 external beam radiotherapy group). All of these patients however, will receive the same trial intervention (the PEG hydrogel).
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284988 0
Hospital
Name [1] 284988 0
Special Purposes and Trust Fund of A/Prof Graham and Associates
Country [1] 284988 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital Cancer Care Centre
Address
1 Short Street, Kogarah
NSW 2217
Country
Australia
Secondary sponsor category [1] 283850 0
Commercial sector/Industry
Name [1] 283850 0
MD Solutions Australasia
Address [1] 283850 0
40A Mason Street Newport
Victoria 3015
Country [1] 283850 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286995 0
South Eastern Sydney Local Health District (NHN) HREC
Ethics committee address [1] 286995 0
Research Support Office G71,
East Wing Edmund Blacket Building
Prince Of Wales Hospital
Randwick NSW 2031
Ethics committee country [1] 286995 0
Australia
Date submitted for ethics approval [1] 286995 0
28/03/2012
Approval date [1] 286995 0
Ethics approval number [1] 286995 0
1/12/0038

Summary
Brief summary
The study will be assessing whether rectal side effects from radiation treatment can be reduced, by using a spacing agent between the rectum and prostate gland. The agent is a gel, which is injected in the space between the prostate gland and rectum, in order to increase separation between these two structures. The idea is that the rectal radiation dose and hence side effects, will be reduced by the increased separation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33990 0
Address 33990 0
Country 33990 0
Phone 33990 0
Fax 33990 0
Email 33990 0
Contact person for public queries
Name 17237 0
Nadine Beydoun
Address 17237 0
St George Hospital Cancer Care Centre
1 Short Street Kogarah
NSW 2217
Country 17237 0
Australia
Phone 17237 0
+61 2 9113 3909
Fax 17237 0
+61 2 9113 3958
Email 17237 0
[email protected]
Contact person for scientific queries
Name 8165 0
Nadine Beydoun
Address 8165 0
St George Hospital Cancer Care Centre
1 Short Street Kogarah
NSW 2217
Country 8165 0
Australia
Phone 8165 0
+61 2 9113 3909
Fax 8165 0
+61 2 9113 3958
Email 8165 0
[email protected]

No information has been provided regarding IPD availability


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.