Prophylactic Vs. Therapeutic Use of Uroxatrol in Men Undergoing Brachytherapy
NCT ID: NCT00201630
Last Updated: 2005-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
150 participants
INTERVENTIONAL
2005-09-30
2005-09-30
Brief Summary
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Detailed Description
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The primary experience in treating obstructive and irritative voiding symptoms is in men with benign prostatic hyperplasia (BPH). In patients with moderate to severe voiding symptomatology, based in the American Urological Association (AUA) Symptom Score Index, medical treatment with alpha antagonists has become commonplace. The use of alpha antagonists is based upon the reduction of smooth muscle tone in both the prostate gland and urinary bladder neck by inhibition of alpha1 adrenoceptor, resulting in relaxation of bladder outlet obstruction and increased urinary flow.
Alfuzosin hydrochloride was approved by the FDA for treatment of the signs and symptoms of BPH in 2003. Alfuzosin differs from other 1-adrenergic receptor blockers by the absences of a piperidine moiety and the presence of a diaminopropyl spacer, which confers alfuzosin with specific biochemical properties. Affinity studies on human-cloned 1 receptor subtypes show that alfuzosin, like terazosin and doxazosin, is devoid of significant receptor subtype selectivity. In isolated human tissues, however, alfuzosin displays the highest selectivity ratio for the prostate over the vascular tissue (ratio, 544) compared with tamsulosin (90), doxazosin (51), and terazosin (19).
Prostate cancer is the most common malignancy in men. One of the most common treatments of prostate cancer is prostate brachytherapy, or radioactive seed implantation. All patients are affected by obstructive and irritative voiding symptoms to various degrees following this procedure due to edema and inflammation induced by trauma and radiation. Many physicians routinely treat obstructive and irritative voiding symptoms following prostate brachytherapy with alpha-blockers. Patients presenting with clinically localized prostate cancer may elect permanent prostate brachytherapy as definitive therapy. The efficacy of such therapy matches that of radical prostatectomy or external beam radiation. Many patients select brachytherapy since it is a single treatment session that is considered minor surgery. Most patients are discharged the same day and they may resume their normal physical activities without restriction almost immediately.
However, the trauma of the needle sticks through the perineum coupled with the effects of the radiation can cause a prostatitis with symptoms similar to irritable bladder or benign prostatic hypertrophy. These symptoms can have considerable impact on the quality of life of the patient and many are medicated with alpha-blockers.
Several studies have attempted to define how best to predict for and treat these symptoms. However, the incidence and severity of these symptoms is difficult to predict. The prophylactic use of alpha-blockers may better control these symptoms in some men undergoing prostate brachytherapy. The aim of this study is to compare outcomes of urinary morbidity following prostate brachytherapy between patients treated with alfuzosin prior to implantation and patients treated following implantation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Uroxatrol (drug)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prior use of alpha-blocker or anti-cholinergic medication in the treatment of prostate hypertrophy.
* Contraindication to using an alpha-blocker
0 Years
MALE
Yes
Sponsors
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Sanofi
INDUSTRY
New York Prostate Institute
OTHER
Principal Investigators
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Louis Potters, MD
Role: STUDY_CHAIR
New York Prostate Institue
Locations
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New York Prostate Institute
Oceanside, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Betsy Guzman
Role: primary
References
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Lefevre-Borg F, O'Connor SE, Schoemaker H, Hicks PE, Lechaire J, Gautier E, Pierre F, Pimoule C, Manoury P, Langer SZ. Alfuzosin, a selective alpha 1-adrenoceptor antagonist in the lower urinary tract. Br J Pharmacol. 1993 Aug;109(4):1282-9. doi: 10.1111/j.1476-5381.1993.tb13762.x.
Related Links
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New York Prostate Institute web site
Other Identifiers
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04-005
Identifier Type: -
Identifier Source: org_study_id