Prostate CancerPhase 3NCT00142506
Study of Sildenafil Citrate During and After Radiotherapy/Hormone Therapy for Erectile Function Versus Radiotherapy/Hormone Therapy for Prostate Cancer
A Phase 3 study testing sildenafil citrate and questionaires in people with Prostate Cancer and Erectile Dysfunction, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
Radiation sometimes affects the ability for a person to have a normal erection. Complete loss of erections after radiation treatment can happen in 40-50% of treated patients. There are medications, like sildenafil (also known as Viagra), that can help the ability to get back erections in almost 70% of such patients. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Erectile Dysfunction
- What is being tested?
- sildenafil citrate and questionaires
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2005to Apr 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To receive external beam radiation therapy and/or brachytherapy for biopsy-proven prostate cancer.
- Baseline International Index of Erectile Function (IIEF) erectile function domain score >= 17.
- Patients receiving radiotherapy with hormone therapy undergoing a maximum of 9 months of hormone therapy will be acceptable.
Who cannot join
- Baseline IIEF-EF (1-30) domain score of <17 pre-therapy
- Current routine use of erectogenic agents (use of agents > 4 times per month would constitute "routine use")
- Neoadjuvant androgen deprivation therapy started more than 1 month prior to entry into study (intake of Bicalutamide alone does not constitute exclusion from study entry)
- Have a clinically significant penile deformity in the opinion of the investigator (ie: Peyronie's Disease)
- Non-organ confined disease
- Prior prostate surgery or cryotherapy
Show all 16Show fewer
- Prior prostate radiotherapy started more than 2 weeks prior to entry into study
- Currently taking 0.8mg Flomax daily
- Penile implant history
- Present at baseline with chronic angina requiring nitrates, angina occurring during sexual intercourse or unstable angina within the last 6 months.
- History of myocardial infarction, coronary artery bypass graft surgery or percutaneous coronary intervention within 90 days of baseline visit.
- History of significant cardiac conduction defect within 90 days of baseline visit.
- Exhibit systolic blood pressure > 170 or < 90 mm Hg or diastolic blood pressure > 100 or < 50 mm Hg at baseline visit or have a history of malignant hypertension
- Have any condition that would interfere with the subject's ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results
- Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens (except finasteride taken as Propecia or Proscar)
- Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memorial Sloan-Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, 11725
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591
About this study
Official title: This Protocol is a Randomized Prospective Study Comparing Prophylactic and on Demand Sildenafil Citrate Usage Administered During and After Radiotherapy With or Without Hormone Therapy Versus Radiotherapy With or Without Hormone Therapy Alone for the Preservation of Erectile Function After Therapy for Potent Patients With Clinically Localized Prostate Cancer
Radiation sometimes affects the ability for a person to have a normal erection. Complete loss of erections after radiation treatment can happen in 40-50% of treated patients. There are medications, like sildenafil (also known as Viagra), that can help the ability to get back erections in almost 70% of such patients.
The purpose of this study is to see if taking Viagra every day starting right before, during and for about 6 months after treatment, could reduce the risk of long-term erectile dysfunction.
Read the detailed description
This protocol is a randomized prospective study comparing prophylactic and on demand Sildenafil Citrate usage administered during and after radiotherapy in combination with or without hormone therapy versus radiotherapy alone for the preservation of erectile function in potent patients with clinically localized prostate cancer. The primary objectives of this protocol are to determine if prophylactic and on demand usage of Sildenafil Citrate can preserve spontaneous erectile function as well as diminish the time to restoration of erectile function in potent men receiving radiotherapy with or without hormone therapy for localized prostate cancer. Secondary objectives of this study are: to determine whether prophylactic and on demand use of Sildenafil Citrate during therapy may improve the long-term response to the drug following treatment; to determine whether prophylactic and on demand use of Sildenafil Citrate during therapy will reduce acute and late urinary effects of radiotherapy; to determine the impact of dosimetry and radiation exposure to both the neurovascular bundle and bulb of the penis on erectile function preservation in the study population undergoing brachytherapy and hormone therapy; to asses the impact on quality of life following prophylactic and on demand Sildenafil Citrate usage in the study population; to determine the relationship between testosterone levels, erectile function and efficacy of prophylactic and on demand Sildenafil Citrate usage in the study population.
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Being tested
- sildenafil citrate and questionaires, placebo tablets and questionaires
- Keywords
- Prostate Cancer, Cancer of the Prostate, Prostate Neoplasms, Prostatic Cancer, Viagra, 05-007
- 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.
sildenafil citrate and questionairesDrug
Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.
Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24.
placebo tablets and questionairesDrug
Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.
In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.
Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | radiotherapy with hormones, questionaire assessments Receives: Drug: sildenafil citrate and questionaires |
| 2 | Placebo comparator | radiotherapy without hormones, questionaire assessments Receives: Drug: placebo tablets and questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Erectile Dysfunction
The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).
Measured: Baseline, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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
- Who is masked
- Participant, Investigator
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Beth Israel Medical Center, St. Luke's-Roosevelt Hospital Center
- Responsible party
- Sponsor
- Investigators
- Michael J Zelefsky, M.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142506
- Sponsor's protocol ID
- 05-007
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2005
- Last updated
- 20 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Protocol is a Randomized Prospective Study Comparing Prophylactic and on Demand Sildenafil Citrate Usage Administered During and After Radiotherapy With or Without Hormone Therapy Versus Radiotherapy With or Without Hormone Therapy Alone for the Preservation of Erectile Function After Therapy for Potent Patients With Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00142506
- Acronym / sponsor ID
- 05-007
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Keywords
- Prostate Cancer, Cancer of the Prostate, Prostate Neoplasms, Prostatic Cancer, Viagra, 05-007
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Beth Israel Medical Center, St. Luke's-Roosevelt Hospital Center
- Study start
- Feb 2005
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Posted 20 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiation sometimes affects the ability for a person to have a normal erection. Complete loss of erections after radiation treatment can happen in 40-50% of treated patients. There are medications, like sildenafil (also known as Viagra), that can help the ability to get back erections in almost 70% of such patients.
The purpose of this study is to see if taking Viagra every day starting right before, during and for about 6 months after treatment, could reduce the risk of long-term erectile dysfunction.
Detailed description
This protocol is a randomized prospective study comparing prophylactic and on demand Sildenafil Citrate usage administered during and after radiotherapy in combination with or without hormone therapy versus radiotherapy alone for the preservation of erectile function in potent patients with clinically localized prostate cancer. The primary objectives of this protocol are to determine if prophylactic and on demand usage of Sildenafil Citrate can preserve spontaneous erectile function as well as diminish the time to restoration of erectile function in potent men receiving radiotherapy with or without hormone therapy for localized prostate cancer. Secondary objectives of this study are: to determine whether prophylactic and on demand use of Sildenafil Citrate during therapy may improve the long-term response to the drug following treatment; to determine whether prophylactic and on demand use of Sildenafil Citrate during therapy will reduce acute and late urinary effects of radiotherapy; to determine the impact of dosimetry and radiation exposure to both the neurovascular bundle and bulb of the penis on erectile function preservation in the study population undergoing brachytherapy and hormone therapy; to asses the impact on quality of life following prophylactic and on demand Sildenafil Citrate usage in the study population; to determine the relationship between testosterone levels, erectile function and efficacy of prophylactic and on demand Sildenafil Citrate usage in the study population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: sildenafil citrate and questionairesradiotherapy with hormones, questionaire assessments |
| 2 | Placebo comparator | Drug: placebo tablets and questionairesradiotherapy without hormones, questionaire assessments |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- To receive external beam radiation therapy and/or brachytherapy for biopsy-proven prostate cancer.
- Baseline International Index of Erectile Function (IIEF) erectile function domain score >= 17.
- Patients receiving radiotherapy with hormone therapy undergoing a maximum of 9 months of hormone therapy will be acceptable.
Key exclusion criteria (16 listed)
- Baseline IIEF-EF (1-30) domain score of <17 pre-therapy
- Current routine use of erectogenic agents (use of agents > 4 times per month would constitute "routine use")
- Neoadjuvant androgen deprivation therapy started more than 1 month prior to entry into study (intake of Bicalutamide alone does not constitute exclusion from study entry)
- Have a clinically significant penile deformity in the opinion of the investigator (ie: Peyronie's Disease)
- Non-organ confined disease
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 |
|---|---|---|
| sildenafil citrate and questionairesHormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months. Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24. | Drug | 1 |
| placebo tablets and questionairesNon-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy. In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months. Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24. | Drug | 2 |
Primary outcome
Assessment of Erectile Dysfunction
Time frame: Baseline, 6 months, 12 months, 24 months
The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Michael J Zelefsky, M.D. principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sildenafil citrate and questionaires in people with Prostate Cancer and Erectile Dysfunction, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
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 3 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: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of Erectile Dysfunction (time frame: Baseline, 6 months, 12 months, 24 months). 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 20 Oct 2017.