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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
001191
ACTR Number:
ACTRN12606000116527
Trial Status:
Registered
Date Submitted:
28/03/2006
Date Registered:
31/03/2006
Page 1
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.
Update:
Reason:
ANZCTR registration 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.
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Reason:
Secondary ID:
UTN:
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Trial acronym:
VEPCaPSED
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Page 2
Health condition(s) or problem(s) studied:
Prostate cancer
Condition category:
Condition code:
Cancer
Prostate
Page 3
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.
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Reason:
Intervention code:
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.
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Reason:
Control group:
Placebo
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Reason:
Page 4
Primary outcome:
Erectile function assessed using the International Index of Erectile Function (IIEF)
Timepoint:
At the start of the study, at commencement of viagra/placebo and at 1, 3, 6, 12 and 24 months.
Secondary outcome:
Testosterone and Follicle Stimulating Hormone (FSH).
Timepoint:
Measured at commencement of Viagra/placebo and at 6, 12 and 24 months.
Page 5
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.
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Reason:
Minimum Age:
40
Years
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Maximum Age:
80
Years
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Gender:
Males
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Healthy volunteers?
No
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Reason:
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.
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Reason:
Page 6
Study type:
Interventional
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Reason:
Purpose of the study:
Prevention
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Allocation to intervention:
Randomised controlled trial
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Reason:
Describe the 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.
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Reason:
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Computer generated randomisation
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Reason:
Masking / blinding:
Blinded (masking used)
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Reason:
Who is/are masked/blinded:
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Reason:
Assignment:
Parallel
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Other design features (specify):
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Type of endpoint(s):
Efficacy
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Page 7
Phase
Phase 3
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Reason:
Anticipated or actual date of first participant enrolement:
12/03/2003
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Reason:
Target sample size:
80
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Reason:
Recruitment status:
Closed: follow-up continuing
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Reason:
Page 8
Funding source 1:
Commercial sector/Industry
Name:
Pfizer Australia
Address:
38-42 Wharf Road, West Ryde, NSW 2114
Country:
Australia
Funding source 2:
Charities/Societies/Foundations
Name:
William Buckland Radiotherapy Centre
Address:
Alfred Hospital, Commercial Road, Melbourne, 3004
Country:
Australia
Funding source 3:
Other
Name:
N/A
Address:
N/A
Country:
Australia
Primary sponsor:
Charities/Societies/Foundations
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Reason:
Name:
William Buckland Radiotherapy Centre
Update:
Reason:
Address:
Alfred Hospital, Commercial Road, Melbourne, 3004
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Reason:
Country:
Australia
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Reason:
Secondary sponsor:
None
Name:
Not applicable
Address:
Country:
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee name 1:
Alfred Hospital
Address:
Country:
Australia
Date of approval:
5/03/2002
HREC Number:
176/01
Ethics Committee name 2:
Peter MacCallum Cancer Centre
Address:
Country:
Australia
Date of approval:
20/09/2004
HREC Number:
04/34
Countries of recruitment:
Australia
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.
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Reason:
Trial website:
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Presentations / publication list:
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Page 10
Contact person for public queries
Name:
Robin Smith
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Reason:
Address:
William Buckland Radiotherapy Centre Alfred Hospital Commercial Road Melbourne VIC 3004
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Reason:
Country:
Australia
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Tel:
+61 3 90762360
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Fax:
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Email:
robin.smith@wbrc.org.au
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Contact person for scientific queries
Name:
Dr Jeremy Millar
Update:
Reason:
Address:
William Buckland Radiotherapy Centre Alfred Hospital Commercial Road Melbourne VIC 3004
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Reason:
Country:
Australia
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Tel:
+61 3 90762337
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Fax:
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Email:
Jeremy.Millar@med.monash.edu.au
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