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Trial registered on ANZCTR


Registration number
ACTRN12623001007628
Ethics application status
Approved
Date submitted
21/08/2023
Date registered
15/09/2023
Date last updated
15/09/2023
Date data sharing statement initially provided
15/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the utility of Intra-cavernous injection of Botulinum neurotoxin for recovery of erectile function after radical prostatectomy: Randomized controlled trial
Scientific title
Assessing the utility of Intra-cavernous injection of Botulinum neurotoxin for recovery of erectile function after radical prostatectomy: Randomized controlled trial
Secondary ID [1] 310396 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erectile Dysfunction 331148 0
Prostate Cancer 331407 0
Condition category
Condition code
Renal and Urogenital 327926 327926 0 0
Other renal and urogenital disorders
Cancer 328154 328154 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
100 u Botulinum toxin type A administered as a once only dose following radical prostatectomy surgery (Randomised 1:1 to placebo)
Mode of administration - Intracavernosal injection
Administered by a urologist
Administered at the end of the procedure in theatre
A record of the administration will be made in the patients medical records
Intervention code [1] 326829 0
Rehabilitation
Intervention code [2] 326830 0
Treatment: Drugs
Comparator / control treatment
Placebo - intracavernosal injection of normal saline following radical prostatectomy surgery
Mode of administration - Intracavernosal injection
Administered by a urologist
Administered at the end of the procedure in theatre
A record of the administration will be made in the patients medical records
Control group
Placebo

Outcomes
Primary outcome [1] 335826 0
Sexual Health Inventory for Men (SHIM) score at 6 months post-surgery
This tools is validated to assess the severity of Erectile dysfunction and is a questionnaire which will be adminstered by medical practitioner or a nurse
Timepoint [1] 335826 0
6 months post surgery (Radical Prostatectomy)
Secondary outcome [1] 425815 0
SHIM score at baseline, 3 months and 12 months post-surgery
This is a validated questionnaire to assess the severity of erectile dysfunction and will be administered by a medical practitioner or a nurse
Timepoint [1] 425815 0
3 months, 6 months and 12 months post surgery (Radical prostatectomy)
Secondary outcome [2] 426516 0
Expanded Prostate Cancer Index Composite (EPIC) - 26 Sexual Function subscale score at baseline, 3 months, 6 months and 12 months post-surgery

This is a validated questionnaire for assessing Sexual function and will be administered by a medical practitioner or a nurse
Timepoint [2] 426516 0
3months, 6months and 12 months post surgery (Radical Prostatectomy)
Secondary outcome [3] 426517 0
Prostate Cancer-Related Quality of Life score at baseline, 3 months, 6 months and 12 months post-surgery

This is a validated questionnaire to assess the Cancer related quality of life and is validated for use in prostate cancer patients post treatment

The questionnaire will be administered by a medical practitioner or a nurse
Timepoint [3] 426517 0
3months, 6months and 12 months post surgery (Radical Prostatectomy)

Eligibility
Key inclusion criteria
• Patients aged between 40-75 years inclusive with a Sexual Health Inventory for Men (SHIM) score of > 21 at baseline who are planned to undergo radical prostatectomy for prostate cancer.
• Patients with plan for unilateral/bilateral nerve sparing surgery
• English speaking
Minimum age
40 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men with locally advanced disease not suitable for nerve sparing surgery
Men on androgen suppressive treatment
Non-English speaking
Patients who have a history of radiotherapy to any of the pelvic organs
Patients who had prior focal therapy for prostate cancer
Patients who have a history of neuromuscular disorders
Men with pre-existing erectile dysfunction defined as a Sexual Health Inventory for Men (SHIM) score of 21 or less

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
NA
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size analysis was conducted by Epworth HealthCare biostatistician A/Prof Dean McKenzie employing Stata 17 statistical software (Stata Corporation, College Station, Texas, 2021). Assuming a difference in 6 month SHIM placebo and 100 u Botox mean scores representing a Cohen’s d of 0.56, 80% statistical power, an alpha of 0.05, 2-tailed, and an independent samples t-test, 52 patients per group would be required. This group size is similar to the group sizes of n=55 and n=62 employed by earlier studies (for the placebo and 100 u Botox groups respectively). Conservatively assuming 15% attrition, 52/0.85 = 61.2 = 62 patients per group or 124 patients in total would be required to complete the study with 52 patients per group or 104 in total.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/11/2023
Actual
Date of last participant enrolment
Anticipated
6/11/2024
Actual
Date of last data collection
Anticipated
6/11/2025
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25423 0
Epworth Richmond - Richmond
Recruitment hospital [2] 25424 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment hospital [3] 25425 0
Footscray Hospital - Footscray
Recruitment hospital [4] 25426 0
Epworth Eastern Hospital - Box Hill
Recruitment postcode(s) [1] 41165 0
3121 - Richmond
Recruitment postcode(s) [2] 41166 0
3002 - East Melbourne
Recruitment postcode(s) [3] 41167 0
3011 - Footscray
Recruitment postcode(s) [4] 41168 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 314771 0
Other
Name [1] 314771 0
Western Urology
Country [1] 314771 0
Australia
Primary sponsor type
Individual
Name
A/Prof Homayoun Zargar
Address
Suite 2/132 La Scala AvenueMaribyrnongVIC 3038
Country
Australia
Secondary sponsor category [1] 316754 0
Individual
Name [1] 316754 0
Dr Brendan Dias
Address [1] 316754 0
Suit 2/132, La Scala Avenue, Maribyrnong VIC 3032
Country [1] 316754 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313781 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 313781 0
The RMH Parkville 300 Grattan St, Parkville, Victoria 3052
Ethics committee country [1] 313781 0
Australia
Date submitted for ethics approval [1] 313781 0
27/10/2021
Approval date [1] 313781 0
30/03/2022
Ethics approval number [1] 313781 0
HREC/77206/MH-2021

Summary
Brief summary
This study is evaluating the utility of an intracavernosal injection of botox for penile rehabilitation in men undergoing a nerve sparing radical prostatectomy, a procedure which causes erectile dysfunction in over two-thirds of patients.

Who is it for?
You may be eligible for this study if you are an adult male aged 40 to 75 years old who has been diagnosed with prostate cancer, and is undergoing unilateral/bilateral nerve sparing radical prostatectomy.

Study details
Participants will be randomly assigned to receive an intracavernosal injection of either botox or normal saline immediately at the end of their surgical procedure (radical prostatectomy). Participants will also be asked to complete questionnaires regarding their sexual function and quality of life at several timepoints during the 12 months following the prostatectomy.

It is hoped that findings from this study will help determine the utility of botox in penile rehabilitation for men with prostate cancer undergoing radical prostatectomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128802 0
A/Prof Homayoun Zargar
Address 128802 0
Western Urology Suite 2/132 La Scala Avenue Maribyrnong VIC 3038
Country 128802 0
Australia
Phone 128802 0
+61 497525876
Fax 128802 0
Email 128802 0
[email protected]
Contact person for public queries
Name 128803 0
Homayoun Zargar
Address 128803 0
Western Urology Suite 2/132 La Scala Avenue Maribyrnong VIC 3038
Country 128803 0
Australia
Phone 128803 0
+61 1300 927 427
Fax 128803 0
Email 128803 0
[email protected]
Contact person for scientific queries
Name 128804 0
Homayoun Zargar
Address 128804 0
Western Urology Suite 2/132 La Scala Avenue Maribyrnong VIC 3038
Country 128804 0
Australia
Phone 128804 0
+61 1300 927 427
Fax 128804 0
Email 128804 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial
When will data be available (start and end dates)?
Beginning 6 months and ending 3 years following main results publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator
[email protected]


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.