Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00931528
First received: June 30, 2009
Last updated: June 14, 2016
Last verified: June 2016
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Sexual Dysfunction
Drug: Tadalafil
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double-blind, Placebo-controlled Phase III Trial to Evaluate the Effectiveness of a Phosphodiesterase 5 Inhibitor, Tadalafil, in Prevention of Erectile Dysfunction in Patients Treated With Radiotherapy for Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Spontaneous (Off-drug) Erectile Function (EF) as Measured by International Index of Erectile Function (IIEF) at Weeks 28-30 After Initiation of Radiation Therapy (RT) [ Time Frame: Baseline to 30 weeks from the start of radiation therapy ] [ Designated as safety issue: No ]
    The primary endpoint is maintenance of spontaneous (off-drug) erectile function at weeks 28-30 after initiation of RT, as measured by the IIEF Q1. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders. We hypothesize that the proportion of patients maintaining erectile function while receiving tadalafil (Arm 1) will be significantly higher than for patients receiving placebo treatment (Arm 2). Treatment differences will be tested at the 0.05 significance level using the Fisher exact test. Point estimates and 95% confidence intervals will also be provided.


Secondary Outcome Measures:
  • Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]
  • Overall Sexual Function as Measured by the IIEF at Weeks 28-30 and Years 1 and 2 After Initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]
  • Patient and Partner Overall Sexual Satisfaction as Measured by the Sexual Adjustment Questionnaire (SAQ) at Weeks 28-30 and Years 1 and 2 After Initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]
  • Patient and Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test at Weeks 28-30 and Years 1 and 2 After Initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]
  • Patient-related Predictors of EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]
  • Patient Follow-up Treatment for Erectile Dysfunction at Weeks 28-30 and Years 1 and 2 After Initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]
  • Radiotherapy Factors Associated With Spontaneous (Off-drug) EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT [ Time Frame: Baseline to 2 years from the start of radiation therapy ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: November 2009
Study Completion Date: November 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tadalafil
Tadalafil
Drug: Tadalafil
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
Placebo Comparator: Placebo
Placebo
Other: Placebo
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 vesicles 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931528

  Show 192 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Investigators
Principal Investigator: Deborah Watkins Bruner, RN, PhD Abramson Cancer Center of the University of Pennsylvania
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00931528     History of Changes
Other Study ID Numbers: RTOG 0831  CDR0000647146  NCI-2011-01934 
Study First Received: June 30, 2009
Results First Received: April 18, 2016
Last Updated: June 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiation Therapy Oncology Group:
sexual dysfunction
stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Tadalafil
Phosphodiesterase 5 Inhibitors
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 23, 2016