None listed
Conditions
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.
Interventions
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.
Sponsors
William Buckland Radiotherapy Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
40 Years to 80 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed