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Trial registered on ANZCTR


Registration number
ACTRN12619000971134
Ethics application status
Approved
Date submitted
3/06/2019
Date registered
9/07/2019
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
ERUPT Trial: Urethral scarring after radiation treatment for prostate cancer
Scientific title
ERUPT Trial: External beam Radiotherapy and Urethral strictures in Prostate cancer Treatment
Secondary ID [1] 298404 0
Nil known
Universal Trial Number (UTN)
U1111-1234-6138
Trial acronym
ERUPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 313106 0
Urethral Strictures 313107 0
Condition category
Condition code
Cancer 311585 311585 0 0
Prostate
Renal and Urogenital 311820 311820 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Uroflow measurements every 6 months for 5 years post radiation treatment for prostate cancer.
AUA surveys every 6 months for 5 years post radiation treatment.
Radiation oncologists and nurses will perform uroflow measurements at each follow up appointment and input data into database.
Each uroflow measurement takes approximately 5-10 minutes to complete.
This follow up will be performed at the radiation oncology centre in Toowoomba via face-to-face appointments.
Intervention code [1] 314650 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320294 0
Incidence of urethral strictures post radiation treatment for prostate cancer by monitoring post-radiotherapy uroflow measurements and patients AUA survey scores.
Timepoint [1] 320294 0
at 6-month intervals up to 5 years post-radiation therapy
Secondary outcome [1] 371086 0
Incidence of other urinary morbidities as a consequence of radiation therapy for prostate cancer. (i.e, dysuria, urinary frequency, nocturia, haematuria). This will be assessed via the AUA surveys that patients complete.
Timepoint [1] 371086 0
at 6 monthly intervals for up to 5 years post radiotherapy

Eligibility
Key inclusion criteria
All adult men >18 years of age who undergo external beam radiotherapy for prostate cancer between 2019-2020. (Commencing in the year 2019)
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men who have previously had pelvic external beam radiatiotherapy for other cancers
Men who have had previous urethral strictures or treatment for urethral strictures.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We estimate that we see approximately 350 patients with prostate cancer who receive radiation therapy in a year.
Patient AUA survey scores and uroflow measurements will be collated and compared against the dosages of radiotherapy to see if certain dosages predispose to the development of urethral strictures.
Patients will then be stratified into 3 outcome groups: no strictures, short term strictures (1-2 years) and long term strictures (3-5 years).
Confounding factors will be initially controlled for then multivariate analysis will be conducted to see if these factors can also predispose to urethral strictures.
Data will be collated in the form of a research paper. Preliminary results will be available after 1 year and may be presented at international conferences.
Target audience will be urologists, radiation oncologists, nurses, trainees, medical students and allied health professionals.
Data will be of mixed categorical and continuous type. The AUA surveys ask that patients rate their symptoms on a score of 0-5 with each question. Scores of 0-7 are classified as mild, 8-19 indicates moderate symptom severity and 20-35 indicates severe symptoms. Uroflow measurements look at the voiding time, flow time, maximum flow rate and volume voided. These are continuous measurements.

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)
QLD
Recruitment hospital [1] 13898 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [2] 13899 0
St Andrew's Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 26671 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 302944 0
Hospital
Name [1] 302944 0
Icon Cancer Care
Address [1] 302944 0
St. Andrew's Toowoomba Hospital
280 North street
Toowoomba QLD 4350
Country [1] 302944 0
Australia
Primary sponsor type
Individual
Name
Michelle Ong
Address
Toowoomba Hospital
154 Pechey Street
Toowoomba QLD 4350
Country
Australia
Secondary sponsor category [1] 302910 0
None
Name [1] 302910 0
Address [1] 302910 0
Country [1] 302910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303506 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 303506 0
154 Pechey Street
Toowoomba QLD 4350
Australia
Ethics committee country [1] 303506 0
Australia
Date submitted for ethics approval [1] 303506 0
05/03/2019
Approval date [1] 303506 0
20/03/2019
Ethics approval number [1] 303506 0
LNR/19/QTDD/47713

Summary
Brief summary
This study will aim to measure the incidence of urethral strictures that develop after external beam radiotherapy for prostate cancer.

Who is it for?
You may be eligible for this study if you are an adult with prostate cancer who is undergoing beam radiation treatment at Toowoomba Base Hospital and St. Andrew’s Private Hospital in Toowoomba, QLD, Australia.

Study details
All participants will need to do is attend an assessment session every 6 months for 5 years. This assessment will involve surveys and a urine flow test that is performed in the clinic. This flow test involves urinating into a flow meter to measure urine flow. It is non-invasive and only takes 2 minutes to complete.

It is hoped that the results from this study will help guide future radiotherapy treatment regimes and aid in the early detection of urethral strictures post-radiotherapy. Thus, leading to a reduction in invasive procedures and decreased overall morbidity. It will also fill the gap in the literature as there are currently no prospective trials on this topic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93902 0
Dr Michelle Ong
Address 93902 0
Toowoomba Hospital
Urology Department
154 Pechey Street
Toowoomba QLD 4350
Country 93902 0
Australia
Phone 93902 0
+61 437001888
Fax 93902 0
Email 93902 0
michelle.ong@health.qld.gov.au
Contact person for public queries
Name 93903 0
Dr Michelle Ong
Address 93903 0
Toowoomba Hospital
Urology Department
154 Pechey Street
Toowoomba QLD 4350
Country 93903 0
Australia
Phone 93903 0
+61 437001888
Fax 93903 0
Email 93903 0
michelle.ong@health.qld.gov.au
Contact person for scientific queries
Name 93904 0
Dr Michelle Ong
Address 93904 0
Toowoomba Hospital
Urology Department
154 Pechey Street
Toowoomba QLD 4350
Country 93904 0
Australia
Phone 93904 0
+61 437001888
Fax 93904 0
Email 93904 0
michelle.ong@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The results of the study will be shared. Namely, the incidence of urethral strictures that are observed in the study population.
When will data be available (start and end dates)?
Data will be available from the year 2020-2024.
Available to whom?
The wide medical community, Namely, other urologists, radiation oncologists, trainees, nurses, junior doctors and medical students.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Data will be shared via a password-protected database amongst the medical community who request access to it which is subject to approvals by the principal investigator. The principal investigator can be contacted via email on michelle.ong@health.qld.gov.au
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Other
'Other' documents specified
Site Specific Approvals
How or where can supporting documents be obtained?
Type [1] 2249 0
Study protocol
Citation [1] 2249 0
Link [1] 2249 0
Email [1] 2249 0
Other [1] 2249 0
Type [2] 2250 0
Informed consent form
Citation [2] 2250 0
Link [2] 2250 0
Email [2] 2250 0
Other [2] 2250 0
Type [3] 2251 0
Ethical approval
Citation [3] 2251 0
Link [3] 2251 0
Email [3] 2251 0
Other [3] 2251 0
Type [4] 2252 0
Other
Citation [4] 2252 0
Link [4] 2252 0
Email [4] 2252 0
Other [4] 2252 0
Site specific Approval
Type [5] 2878 0
Other
Citation [5] 2878 0
Link [5] 2878 0
Email [5] 2878 0
Other [5] 2878 0
Site Specific Approval
Summary results
No Results