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Trial registered on ANZCTR


Registration number
ACTRN12606000116527
Ethics application status
Approved
Date submitted
28/03/2006
Date registered
31/03/2006
Date last updated
20/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised double-blind controlled trial of the use of daily sildenafil (Viagra) in men with early prostate cancer treated with radiation, for the prevention of subsequent erectile dysfunction.
Scientific title
Randomised double-blind controlled trial of the use of daily sildenafil (Viagra) in men with early prostate cancer treated with radiation, for the prevention of subsequent erectile dysfunction.
Universal Trial Number (UTN)
Trial acronym
VEPCaPSED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 1081 0
Condition category
Condition code
Cancer 1161 1161 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised to receive either sildenafil (Viagra) after their radiation treatment is complete and will commence 1 month after completion of all treatment for prostate cancer. Patients will be commenced on 50mg sildenafil taken orally once daily. If there are no adverse events after 1 month the dose will be increased to 100mg (two 50mg tablets) taken orally daily for a total period of medication of 24 weeks. The trial medication will then cease.
Intervention code [1] 959 0
Prevention
Comparator / control treatment
Patients will be randomised to receive placebo after their radiation treatment is complete and will commence 1 month after completion of all treatment for prostate cancer. Patients will be commenced on placebo (1 tablet) taken orally once daily.
Control group
Placebo

Outcomes
Primary outcome [1] 1566 0
Erectile function assessed using the International Index of Erectile Function (IIEF)
Timepoint [1] 1566 0
At the start of the study, at commencement of viagra/placebo and at 1, 3, 6, 12 and 24 months.
Secondary outcome [1] 2818 0
Testosterone and Follicle Stimulating Hormone (FSH).
Timepoint [1] 2818 0
Measured at commencement of Viagra/placebo and at 6, 12 and 24 months.

Eligibility
Key inclusion criteria
Adenocarcinoma of the prostate, planned radiation tretment with curative intent, can speak and read English well enough to complete self-reporting questionnaires, score of greater than 10 in the erectile domain score of the IIEF.
Minimum age
40 Years
Maximum age
80 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men with absent erectile function, high risk disease: >T3a or PSA >20 or Gleason combined score >7, men with contraindications for Viagra, long term androgen deprivation planned after completion of radiotherapy, past history of radical prostatectomy, anatomic deformity of the penis: Peyronie's disease, cavernosal fibrosis.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Trial pharmacist will randomise patients and prepare active agent or placebo. Only authorised clinical trial pharmacy staff will be aware of the treatment allocation. Dispensing labels of medication will be marked 'active/placebo'. The active agent and placebo will be identical in appearance.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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)

Funding & Sponsors
Funding source category [1] 1269 0
Commercial sector/Industry
Name [1] 1269 0
Pfizer Australia
Address [1] 1269 0
38-42 Wharf Road, West Ryde, NSW 2114
Country [1] 1269 0
Australia
Funding source category [2] 2514 0
Charities/Societies/Foundations
Name [2] 2514 0
William Buckland Radiotherapy Centre
Address [2] 2514 0
Alfred Hospital, Commercial Road, Melbourne, 3004
Country [2] 2514 0
Australia
Funding source category [3] 2515 0
Other
Name [3] 2515 0
N/A
Address [3] 2515 0
N/A
Country [3] 2515 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
William Buckland Radiotherapy Centre
Address
Alfred Hospital, Commercial Road, Melbourne, 3004
Country
Australia
Secondary sponsor category [1] 1124 0
None
Name [1] 1124 0
Not applicable
Address [1] 1124 0
Country [1] 1124 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2600 0
Alfred Hospital
Ethics committee address [1] 2600 0
Ethics committee country [1] 2600 0
Australia
Date submitted for ethics approval [1] 2600 0
Approval date [1] 2600 0
05/03/2002
Ethics approval number [1] 2600 0
176/01
Ethics committee name [2] 2601 0
Peter MacCallum Cancer Centre
Ethics committee address [2] 2601 0
Ethics committee country [2] 2601 0
Australia
Date submitted for ethics approval [2] 2601 0
Approval date [2] 2601 0
20/09/2004
Ethics approval number [2] 2601 0
04/34

Summary
Brief summary
All staff and patients will be blinded from allocation of active agent/placebo. Only authorised clinical trial pharmacy staff will have access to this information. If a medical emergency requires unblinding, the principal investigator is required to provide authorisation for clinical trial pharmacy staff to unblind.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36358 0
Address 36358 0
Country 36358 0
Phone 36358 0
Fax 36358 0
Email 36358 0
Contact person for public queries
Name 10148 0
Robin Smith
Address 10148 0
William Buckland Radiotherapy Centre
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 10148 0
Australia
Phone 10148 0
+61 3 90762360
Fax 10148 0
Email 10148 0
robin.smith@wbrc.org.au
Contact person for scientific queries
Name 1076 0
Dr Jeremy Millar
Address 1076 0
William Buckland Radiotherapy Centre
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 1076 0
Australia
Phone 1076 0
+61 3 90762337
Fax 1076 0
Email 1076 0
Jeremy.Millar@med.monash.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary