Study of Sildenafil Citrate During and After Radiotherapy/Hormone Therapy for Erectile Function Versus Radiotherapy/Hormone Therapy for Prostate Cancer - NCT00142506-07920 (Clinical Trial 127903)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy127903.aspx
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| City: |
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Basking Ridge |
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State:
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NJ |
| Zip Code: |
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07920 |
| Conditions: |
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Prostate Cancer - Erectile Dysfunction |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Prior prostate radiotherapy started more than 2 weeks prior to entry into study
- Currently taking 2 Flomax
- 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. |
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| Study is available at: |
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Memorial Sloan-Kettering Cancer Center at Basking Ridge
Basking Ridge, NJ 07920
United States
Primary Contact:
Michael Zelefsky, MD
Email: zelefskm@mskcc.org
Phone: 212-639-6802
Secondary Contact:
Michael J. Zelefsky, M.D.
Email: zelefskm@mskcc.org
Phone: 212-639-6802 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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