Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000537752
Ethics application status
Approved
Date submitted
28/03/2022
Date registered
6/04/2022
Date last updated
15/08/2023
Date data sharing statement initially provided
6/04/2022
Date results information initially provided
15/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the activity of pseudoephedrine in treating retrograde ejaculation following retroperitoneal lymph node dissection (RPLND) in survivors of testicular cancer - Part A
Scientific title
Exploring the activity of pseudoephedrine in treating retrograde ejaculation following retroperitoneal lymph node dissection (RPLND) in survivors of testicular cancer - Part A
Secondary ID [1] 306786 0
PMC81808 - Part A
Universal Trial Number (UTN)
Trial acronym
PREPARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Testicular cancer 325835 0
Retroperitoneal lymph node dissection 325840 0
Condition category
Condition code
Cancer 323161 323161 0 0
Testicular
Surgery 323162 323162 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
PREPARE Part A is a prospective, observational cohort study enrolling any individual who underwent retroperitoneal lymph node dissection (RPLND) at least six months prior for management of testicular cancer. After consent and confirmation of eligibility, eligible participants will complete a once-off series of health-related quality of life (HRQoL) questionnaires either online or on paper to inform the prevalence of retrograde ejaculation and impact (if any) of retrograde ejaculation on HRQoL. It is anticipated that completion of the questionnaires will take up to 20 minutes.

Participants will also be invited to participate in an optional, semi-structured interview, which will last up to 45 minutes. This will be coordinated at a time convenient to the participant at a later fate.
Intervention code [1] 323242 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330911 0
Prevalence of retrograde ejaculation in participants receiving clinical follow-up following retroperitoneal lymph node dissection as assessed by patient report in supplementary questions (designed for PREPARE).
Timepoint [1] 330911 0
At enrolment.
Secondary outcome [1] 408040 0
Health-related quality of life (HRQoL) as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer-30 (EORTC QLQ-C30) at enrolment in participants reporting retrograde ejaculation, compared to those not experiencing retrograde ejaculation.
Timepoint [1] 408040 0
At enrolment.
Secondary outcome [2] 408041 0
Sexual function as measured by sexual function items of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer-30 (EORTC QLQ-TC26) at enrolment in participants reporting retrograde ejaculation, compared to those not experiencing retrograde ejaculation.
Timepoint [2] 408041 0
At enrolment.
Secondary outcome [3] 408042 0
Sexual function as measured by the Brief Male Sexual Function Inventory (BMSFI) in participants reporting retrograde ejaculation, compared to those not experiencing retrograde ejaculation
Timepoint [3] 408042 0
At enrolment.
Secondary outcome [4] 408043 0
Fertility and retrograde ejaculation as measured by supplementary questions (designed for PREPARE) in participants reporting retrograde ejaculation, compared to those not experiencing retrograde ejaculation.
Timepoint [4] 408043 0
At enrolment.

Eligibility
Key inclusion criteria
Participants must meet all the following criteria for study entry:
1. Participant has provided written, informed consent OR electronic, informed consent sighted by an investigator, on Telehealth.
2. Males greater than or equal to 18 years at time of informed consent.
3. Histologically confirmed testicular germ cell tumour (based on archival tissue report)
4. Retroperitoneal lymph node dissection for management of testicular cancer at least six months prior to consent.
5. Participant is willing and able to comply with the protocol for the duration of the study including treatment, and scheduled visits and examination including follow up.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who meet any of the following criteria will be excluded from study entry:
1. Currently receiving treatment or planning to receive treatment within two months (i.e., surgery, chemotherapy, radiotherapy) for testicular cancer (or other malignancy).
2. Known medical condition or other issue that in the opinion of the investigator, that would affect adherence to study requirements.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Baseline demographic and clinical characteristics collected during screening in PREPARE will be presented in tabular format and analysed using descriptive statistics and Student t-tests, where comparisons between groups are required. A p value of <0.05 will define statistical significance.
The primary outcome will be summarised descriptively with the prevalence of retrograde ejaculation defined as the number of participants reporting retrograde ejaculation, of all men recruited to this study.
Secondary outcomes will also be summarised descriptively, including mean and median, where relevant. HRQoL measures will be summarised using means and 95% confidence intervals of the means of men experiencing (or not) retrograde ejaculation. An analysis of covariance will be fitted to determine impact of retrograde ejaculation on HRQoL and time from RPLND.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/08/2022
Actual
16/08/2022
Date of last participant enrolment
Anticipated
30/06/2023
Actual
18/05/2023
Date of last data collection
Anticipated
28/07/2023
Actual
15/06/2023
Sample size
Target
50
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22057 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 37180 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 311123 0
Charities/Societies/Foundations
Name [1] 311123 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) Below the Belt Research Fund
Country [1] 311123 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Office of Cancer Research, Peter MacCallum Cancer Centre
305 Grattan St, Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 312467 0
None
Name [1] 312467 0
Address [1] 312467 0
Country [1] 312467 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310653 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 310653 0
305 Grattan St, Melbourne, VIC, 3000
Ethics committee country [1] 310653 0
Australia
Date submitted for ethics approval [1] 310653 0
03/12/2021
Approval date [1] 310653 0
10/03/2022
Ethics approval number [1] 310653 0
21/231

Summary
Brief summary
The aim of this study is to determine how common retrograde ejaculation is in patients following retroperitoneal lymph node dissection for the treatment of testicular cancer and the impacts that this might have on quality of life.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, have a confirmed diagnosis of a testicular germ cell tumour, have received retroperitoneal lymph node dissection at least 6 months ago.

Study details
All participants will be invited to complete a once-off series of questionnaires assessing quality of life, which is expected to take around 20 minutes to complete. Additionally, participants will be invited to partake in an optional semi-structured interview, which will last up to 45 minutes and will occur at a later time.

It is hoped that this study will contribute important data to help understand the impact of retrograde ejaculation following retroperitoneal lymph node dissection has on survivors of testicular cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118402 0
A/Prof Ben Tran
Address 118402 0
Peter MacCallum Cancer Centre
305 Grattan St, Melbourne, VIC, 3000
Country 118402 0
Australia
Phone 118402 0
+613 8559 7902
Fax 118402 0
Email 118402 0
ben.tran@petermac.org
Contact person for public queries
Name 118403 0
A/Prof Ben Tran
Address 118403 0
Peter MacCallum Cancer Centre
305 Grattan St, Melbourne, VIC, 3000
Country 118403 0
Australia
Phone 118403 0
+613 8559 7902
Fax 118403 0
Email 118403 0
ben.tran@petermac.org
Contact person for scientific queries
Name 118404 0
A/Prof Ben Tran
Address 118404 0
Peter MacCallum Cancer Centre
305 Grattan St, Melbourne, VIC, 3000
Country 118404 0
Australia
Phone 118404 0
+613 8559 7902
Fax 118404 0
Email 118404 0
ben.tran@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial can be shared following application to the Sponsor for use of data in participants who provide optional consent.
When will data be available (start and end dates)?
Following final analysis and publication of PREPARE and up to five years thereafter.
Available to whom?
To collaborators and other research parties.
Available for what types of analyses?
For related, ethically-approved research.
How or where can data be obtained?
Through direct application to the Sponsor via Principal Investigator (ben.tran@petermac.org)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo n/a

Documents added automatically
No additional documents have been identified.