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A Study to Assess the Efficacy of Tadalafil to Treat Erectile Dysfunction After Radiotherapy of Prostate Cancer

Phase 3
18 Years
Not Enrolling
Prostate Cancer, Erectile Dysfunction

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Trial Information

A Study to Assess the Efficacy of Tadalafil to Treat Erectile Dysfunction After Radiotherapy of Prostate Cancer

Prostate cancer has become the most frequent malignancy in older men in Western countries.
Radiotherapy is a common treatment modality for early stage prostate cancer. 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. Oral
drug therapy represents the first-line management option for patients with ED. The results
of the studies completed thus far with sildenafil show that a phosphodiesterase type 5
inhibitor is a safe and efficacious drug for the treatment of post-radiation ED. No studies
have investigated the efficacy of tadalafil in men complaining of ED after radiotherapy of
prostate cancer. Because of the extended period of effectiveness, which may last up to 36
hours after intake, tadalafil allows freedom in the choice for time of sexual activity. Also
the absence of restrictions of tadalafil intake with food or alcohol should simplify its
administration. This randomized, double-blind, placebo-controlled, cross-over study has been
designed to evaluate the efficacy and safety of “on demand” dosing of 20-mg of tadalafil or
placebo administered for 12 weeks to patients with ED after external-beam radiotherapy for
prostate cancer.

Inclusion Criteria:

- Heterosexual men, at least 18 years of age at Visit 1 and willing to participate in
the study. If a qualifying participant has more than one female sexual partner during
the study, the participant will not be excluded from the trial. However, the
participant will be required to respond to the questionnaires based on the
participant's sexual interactions with only one of these partners.

- Patients with histologically proven prostate cancer.

- Provide signed informed consent.

- Developed ED (defined as a consistent change in the quality of erection that
adversely affects the patient’s satisfaction with sexual intercourse) subsequent to
EBRT for prostate cancer.

- Patients willing to make on average 1 sexual intercourse attempt every week during
the study (including the 4-week run-in period without medication).

- Agree not to use any other ED treatment for at least 4 weeks before receiving the
initial dose of study drug (ie, during the run-in period and during the treatment
phase of the study).

- Have been treated by EBRT at least 12 months before screening and were documented to
be potent before undergoing EBRT.

Exclusion Criteria:

- Patients will not be randomized if they did not make at least 1 sexual intercourse
attempt during the run-in period. Also patients who are unable to appropriately
complete the questionnaires will not be randomized.

- ED caused by other primary sexual disorders including premature ejaculation or ED
caused by untreated endocrine disease (eg, hypopituitarism, hypothyroidism, or

- History of pelvic surgery (including radical prostatectomy)

- Treatment with cancer chemotherapy or anti-androgens.

- Have a raising prostate specific antigen level or metastases at Visit 1.

- History of penile implant.

- The presence of clinically significant penile deformity in the opinion of the

- Evidence of clinically significant renal insufficiency within the last 6 months
before Visit 1.

- Active symptomatic hepatobiliary disease, including patients with evidence of
jaundice at Visit 1.

- 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.

- Patients having met the criteria for unstable angina (Braunwald, 1989) within 6
months before Visit 1, history of myocardial infarction or coronary artery bypass
graft surgery within 90 days before Visit 1, or percutaneous coronary intervention
(eg, angioplasty or stent placement) within 90 days before Visit 1.

- 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

- A history of sudden cardiac arrest despite medical or device therapy.

- Any evidence of congestive heart failure class 2 or above within 6 months before
Visit 1 (Criteria Committee, New York Heart Association, Inc., 1964).

- A new, significant conduction defect within 90 days before Visit 1.

- 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.

- History of significant central nervous system injuries (including stroke and spinal
cord injury) within the 6 months before Visit 1.

- History of HIV infection.

- 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.

- History of drug, alcohol, or substance abuse within the 6 months before Visit 1.

- Treatment within the 30 days before Visit 1 with a drug or device that has not
received regulatory approval.

- Have any condition, limitation, or disease that could, in the judgment of the
investigator, preclude evaluation of response to tadalafil.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of 20 mg tadalafil, in comparison with placebo, in men with ED after 3-D conformal radiotherapy (3DCRT) of prostate cancer

Principal Investigator

Luca Incrocci, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Erasmus MC


Netherlands: Medical Ethics Review Committee (METC)

Study ID:




Start Date:

February 2003

Completion Date:

February 2005

Related Keywords:

  • Prostate Cancer
  • Erectile Dysfunction
  • Prostate cancer
  • Radiotherapy
  • Erectile dysfunction
  • Tadalafil
  • Prostatic Neoplasms
  • Erectile Dysfunction