500 Boylston Street, Boston, MA 02116 617-419-4700
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RATIONALE: Tadalafil may help prevent erectile dysfunction in patients with prostate cancer
that has been treated with radiation therapy. It is not yet known whether tadalafil is more
effective than a placebo in preventing erectile dysfunction.
PURPOSE: This randomized phase III trial is studying tadalafil to see how well it works
compared with a placebo in preventing erectile dysfunction in patients with prostate cancer
treated with radiation therapy.
Ages:18 and older
DISEASE CHARACTERISTICS: - Meets 1 of the following criteria: - Diagnosis of adenocarcinoma of the prostate within the past 6 months - Clinical stage T1b-T2b - No distant metastases - Clinically negative lymph nodes established by imaging (pelvic ± abdominal CT or MRI), nodal sampling, or dissection within the past 3 months - Patients with lymph nodes equivocal or questionable by imaging are eligible provided the nodes are ≤ 1.5 cm - Lymph node assessment is optional and at the investigator's discretion for patients with Gleason score < 7 - No evidence of bone metastases on bone scan within the past 3 months - Equivocal bone scan findings allowed provided plain films are negative for metastasis - Bone metastasis assessment is optional and at the investigator's discretion for patients with Gleason score < 7 - Baseline serum prostate-specific antigen (PSA) value performed with an FDA-approved assay within the past 3 months and meets 1 of the following criteria: - Gleason score < 7 and PSA < 20 ng/mL - Gleason score ≥ 7 and PSA < 15 ng/mL - Planning to undergo treatment with either external radiotherapy alone to the prostate ± seminal vesicals only at a dose of 75-79.2 Gy OR brachytherapy alone - Pretreatment erectile function as measured by International Index of Erectile Function questionnaire response 3, 4, or 5 on question 1 - Spouse or partner of these patients (optional) - Male or female PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - Serum total testosterone level normal prior to the initiation of radiotherapy - No myocardial infarction within the past year - No heart failure within the past 6 months - No stroke within the past 6 months - No uncontrolled arrhythmias, hypotension (BP < 90/50 mm Hg), or uncontrolled hypertension (BP > 170/100 mm Hg) - No known moderate to severe renal insufficiency or end-stage renal disease - No known severe hepatic impairment - No prior or concurrent invasive cancer (stage > 0) except for localized basal cell or squamous cell skin carcinoma (stage 0-II), or a hematological malignancy (e.g., leukemia, lymphoma, myeloma) unless disease-free ≥ 5 years - No known AIDS based upon current Centers for Disease Control (CDC) definition - No anatomical genital abnormalities or concurrent conditions that, in the estimation of the physician, would prohibit sexual intercourse or prevent study completion - No major medical or psychiatric illness that, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow up PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Prior tadalafil allowed - No prior penile implant or history of bilateral orchiectomy - No prior prostatectomy, prostatic cryosurgery, high-intensity focused ultrasound, radionuclide prostate brachytherapy, or chemotherapy for prostate cancer - No prior or anticipated combined external radiotherapy and brachytherapy - No prior or anticipated external radiotherapy to the pelvic ± para-aortic lymph nodes - More than 6 months since prior leuteinizing hormone-releasing hormone agonist androgen suppression (e.g., leuprolide acetate, goserelin), antiandrogen (e.g., flutamide, bicalutamide, or nilutamide), or estrogenic (e.g., diethylstilbestrol) agents - At least 5-7 days since prior use of mechanical (vacuum) devices, intracorporeal, intraurethral, topical, or oral (sildenafil, tadalafil, vardenafil) agents as therapy for erectile dysfunction (ED) or supplements to enhance sexual function - No other concurrent medical research study that involves the treatment of ED - No concurrent use of any organic nitrate or as-needed nitrates (e.g., use of nitroglycerin) - No concurrent cimetidine, ketoconazole, itraconazole, erythromycin, or ritonavir
Sponsor: Radiation Therapy Oncology Group
Phase: Phase 3
Trial ID: NCT00931528
Accepting Healthy Volunteers