Prostate CancerPhase 3NCT00215631
Can Tadalafil Maintain Erectile Function In Patients Treated With Radiotherapy For 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.
Trial summary
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. 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
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2005to Nov 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
- Men, at least 18 years of age, willing to participate in the study and willing to regularly attempt sexual activity.
- Patients with histologically proven prostate cancer.
- Provide signed informed consent.
- Patients with normal erectile function defined as a combined score >=8 of questions 3 and 4 of the IIEF.
- Agree not to use any other ED treatment during the study.
Who cannot join
- Use of any treatment for ED before the start of the study.
- History of pelvic surgery (including radical prostatectomy)
- History of penile implant
- The presence of penile deformity that makes sexual intercourse difficult or impossible.
- 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 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.
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- 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 or a new, significant conduction defect within 90 days before screening.
- 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 screening.
- 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.
- Treatment with cancer chemotherapy.
- History of drug, alcohol, or substance abuse within the 6 months before screening.
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer, Erectile Dysfunction
- 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.
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 outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2005
- Study completionNov 2005
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Luca Incrocci, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215631
- Sponsor's protocol ID
- 2004-165
- Status last verified
- Apr 2007
- First submitted
- 18 Sep 2005
- Last updated
- 15 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00215631
- Acronym / sponsor ID
- 2004-165
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Keywords
- prostate cancer, radiotherapy, erectile dysfunction, tadalafil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 100 participants
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Nov 2005 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men, at least 18 years of age, willing to participate in the study and willing to regularly attempt sexual activity.
- Patients with histologically proven prostate cancer.
- Provide signed informed consent.
- Patients with normal erectile function defined as a combined score >=8 of questions 3 and 4 of the IIEF.
- Agree not to use any other ED treatment during the study.
Key exclusion criteria (16 listed)
- Use of any treatment for ED before the start of the study.
- History of pelvic surgery (including radical prostatectomy)
- History of penile implant
- The presence of penile deformity that makes sexual intercourse difficult or impossible.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tadalafil | Drug | – |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Incrocci, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
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 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 15 Sep 2015. 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 was stopped early (reason given: slow recruitment). Results are not available in the source record.
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 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2015.