Study of Sildenafil Citrate During and After Radiotherapy/Hormone Therapy for Erectile Function Versus Radiotherapy/Hormone Therapy for Prostate Cancer
Condition: Prostate Cancer; Erectile Dysfunction
MeSH terms: Prostatic Neoplasms; Erectile Dysfunction
Intervention: sildenafil citrate and questionaires; placebo tablets and questionaires
Intervention description: Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.
Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24.; Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.
In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.
Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24.
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 290.0
Sex: Male
Healthy volunteers: No
Keywords: Prostate Cancer; Cancer of the Prostate; Prostate Neoplasms; Prostatic Cancer; Viagra; 05-007

Summary:

      Radiation sometimes affects the ability for a person to have a normal erection. Complete loss
      of erections after radiation treatment can happen in 40-50% of treated patients. There are
      medications, like sildenafil (also known as Viagra), that can help the ability to get back
      erections in almost 70% of such patients.

      The purpose of this study is to see if taking Viagra every day starting right before, during
      and for about 6 months after treatment, could reduce the risk of long-term erectile
      dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  To receive external beam radiation therapy and/or brachytherapy for biopsy-proven
             prostate cancer.

          -  Baseline International Index of Erectile Function (IIEF) erectile function domain
             score >= 17.

          -  Patients receiving radiotherapy with hormone therapy undergoing a maximum of 9 months
             of hormone therapy will be acceptable.

        Exclusion Criteria:

          -  Baseline IIEF-EF (1-30) domain score of <17 pre-therapy

          -  Current routine use of erectogenic agents (use of agents > 4 times per month would
             constitute "routine use")

          -  Neoadjuvant androgen deprivation therapy started more than 1 month prior to entry into
             study (intake of Bicalutamide alone does not constitute exclusion from study entry)

          -  Have a clinically significant penile deformity in the opinion of the investigator (ie:
             Peyronie's Disease)

          -  Non-organ confined disease

          -  Prior prostate surgery or cryotherapy

          -  Prior prostate radiotherapy started more than 2 weeks prior to entry into study

          -  Currently taking 0.8mg Flomax daily

          -  Penile implant history

          -  Present at baseline with chronic angina requiring nitrates, angina occurring during
             sexual intercourse or unstable angina within the last 6 months.

          -  History of myocardial infarction, coronary artery bypass graft surgery or percutaneous
             coronary intervention within 90 days of baseline visit.

          -  History of significant cardiac conduction defect within 90 days of baseline visit.

          -  Exhibit systolic blood pressure > 170 or < 90 mm Hg or diastolic blood pressure > 100
             or < 50 mm Hg at baseline visit or have a history of malignant hypertension

          -  Have any condition that would interfere with the subject's ability to provide informed
             consent or comply with study instructions, would place subject at increased risk, or
             might confound the interpretation of the study results

          -  Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens
             (except finasteride taken as Propecia or Proscar)

          -  Have a history of drug, alcohol, or substance abuse within the past 6 months, as
             assessed by the investigator.