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Prostate CancerPhase 3NCT00122499

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

A Phase 3 study testing tadalafil in people with Prostate Cancer and Erectile Dysfunction, run by Erasmus Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study has been designed to evaluate the efficacy and safety of a 20-mg dose of tadalafil administered "on demand" to patients with erectile dysfunction (ED) after external-beam radiotherapy (EBRT) of prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Erectile Dysfunction
What is being tested?
tadalafil
How many people
Not given
Where
1 siteNetherlands
Study dates
Feb 2003to Feb 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 hypogonadism).
  • 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.
Show all 22Show fewer
  • The presence of clinically significant penile deformity in the opinion of the investigator.
  • 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 cardioverter-defibrillator.
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Erasmus MC

    Rotterdam, 3008 AE

Other trials in Netherlands

About this study

This study has been designed to evaluate the efficacy and safety of a 20-mg dose of tadalafil administered "on demand" to patients with erectile dysfunction (ED) after external-beam radiotherapy (EBRT) of prostate cancer.

Read the detailed description

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.

Being tested
tadalafil
Keywords
Prostate cancer, Radiotherapy, Erectile dysfunction, Tadalafil
Medical subject headings
Prostatic Neoplasms, Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tadalafilDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

Secondary outcomes (2)

  1. Responses to the Global Assessment Questions (GAQ), and the other items of the Sexual Encounter Profile (SEP) and International Index of Erectile Function (IIEF)

  2. To assess the side effects of 20 mg tadalafil in men with ED after 3DCRT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2005 (estimated)
  2. Study startFeb 2003
  3. Study completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00122499
Sponsor's protocol ID
232.476/2003/180
Status last verified
Jul 2005
First submitted
19 Jul 2005
Last updated
27 Jul 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tadalafil in people with Prostate Cancer and Erectile Dysfunction, run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00122499.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2005.

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