Can Tadalafil Maintain Erectile Function In Patients Treated With Radiotherapy For Prostate Cancer?

This study has been terminated.
(slow recruitment)
Sponsor:
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00215631
First received: September 18, 2005
Last updated: April 3, 2007
Last verified: April 2007
  Purpose

Because of the high incidence of post-radiation erectile dysfunction (ED), up to 72% after external-beam radiotherapy, this patient category represents a most difficult therapeutic challenge. Therefore, prevention of ED could be more effective than treatment. Tadalafil, a new phosphodiesterase type 5 inhibitor, has been recently introduced. No studies have investigated the efficacy of tadalafil in preventing ED in patients undergoing radiotherapy for prostate cancer. Efficacy of tadalafil can last up to 36 hours after intake. This will result in a prolonged and continuos enhancement of penile vascular responsiveness. This randomized, double-blind, placebo-controlled study has been designed to evaluate the efficacy of 20-mg of tadalafil administered for 12 months in maintaining erectile function of potent patients undergoing external-beam radiotherapy for prostate cancer.


Condition Intervention Phase
Prostate Cancer
Erectile Dysfunction
Drug: tadalafil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Can Tadalafil (Cialis)® Maintain Erectile Function In Patients Treated With External-Beam Radiotherapy For Prostate Cancer? A Randomized, Double-Blind, Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • To assess the efficacy, and safety, of 20 mg tadalafil once every 2 days, in comparison with placebo, to maintain erectile function of patients undergoing external-beam radiotherapy for prostate cancer.

Secondary Outcome Measures:
  • Erectile function defined as the sum of questions 3 and 4 of the IIEF questionnaire every 3 months till the end of the study (at 3-6-12-24 months).
  • Erectile function domain of the IIEF, defined as the sum of questions 1-5, and 15 of the IIEF questionnaire, questions 2 and 3 of the Sexual Encounter Profile (SEP), and responses to the other questions of the IIEF, at 3-6-12-24 months after initiation

Estimated Enrollment: 100
Study Start Date: October 2005
Study Completion Date: November 2005
Detailed Description:

It will be a double-blind, placebo-controlled, randomized trial. Patients scheduled for external-beam radiotherapy for prostate cancer will start using tadalafil 20 mg or placebo the first day of radiation. The blinded medication (active drug or placebo) has to be taken once every two days starting the day of the first radiation up to 12 months (52 weeks) after radiotherapy. The active drug or placebo may be taken at bedtime unrelated to sexual activity. In case of side effects the dose can be reduced to 10 mg. Erectile function will be assessed every 3 months up to 6 weeks (week 58) after discontinuation of drug treatment by using questions 3 and 4 of the International Index of Erectile Function (IIEF). Responders (maintained erectile function) are defined as having a combined score of >=8 for the IIEF questions 3 and 4.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men, at least 18 years of age, willing to participate in the study and willing to regularly attempt sexual activity.
  2. Patients with histologically proven prostate cancer.
  3. Provide signed informed consent.
  4. Patients with normal erectile function defined as a combined score >=8 of questions 3 and 4 of the IIEF.
  5. Agree not to use any other ED treatment during the study.

Exclusion Criteria:

  1. Use of any treatment for ED before the start of the study.
  2. History of pelvic surgery (including radical prostatectomy)
  3. History of penile implant
  4. The presence of penile deformity that makes sexual intercourse difficult or impossible.
  5. Patients with chronic stable angina treated with long-acting nitrates, or patients with chronic stable angina who have required short-acting nitrates in the last 90 days, or angina occurring during sexual intercourse in the last 6 months.
  6. Patients with unstable angina, history of myocardial infarction or coronary artery bypass graft surgery or percutaneous coronary intervention (eg, angioplasty or stent placement) within 90 days before screening.
  7. Any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 bpm) at rest despite medical or device therapy, or any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for 30 sec) despite medical or device therapy, or the presence of an automatic internal cardioverter-defibrillator.
  8. A history of sudden cardiac arrest despite medical or device therapy.
  9. Any evidence of congestive heart failure or a new, significant conduction defect within 90 days before screening.
  10. Systolic blood pressure >170 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg, or patients with a history of malignant hypertension.
  11. History of significant central nervous system injuries (including stroke and spinal cord injury) within the 6 months before screening.
  12. History of HIV infection.
  13. Any condition that would interfere with the patient’s ability to provide informed consent or comply with study instructions, would place patient at increased risk, or might confound the interpretation of the study results.
  14. Treatment with cancer chemotherapy.
  15. History of drug, alcohol, or substance abuse within the 6 months before screening.
  16. Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to tadalafil.
  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: NCT00215631

Locations
Netherlands
Erasmus MC-Daniel den Hoed Cancer
Rotterdam, Netherlands, 3008 AE
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: Luca Incrocci, MD, PhD Erasmus MC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00215631     History of Changes
Other Study ID Numbers: 2004-165
Study First Received: September 18, 2005
Last Updated: April 3, 2007
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Erasmus Medical Center:
prostate cancer
radiotherapy
erectile dysfunction
tadalafil

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

ClinicalTrials.gov processed this record on October 29, 2014