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Randomized, Open-Labeled Study of Prophylactic Vs. Therapeutic Use of Uroxatrol to Determine Improvements in Urinary Morbidity Following Men Undergoing Prostate Brachytherapy

Phase 3
Not Enrolling
Prostate Cancer

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Trial Information

Randomized, Open-Labeled Study of Prophylactic Vs. Therapeutic Use of Uroxatrol to Determine Improvements in Urinary Morbidity Following Men Undergoing Prostate Brachytherapy

Prostate brachytherapy is an increasingly popular method of treating clinically localized
prostate cancer. The major morbidity of this procedure is obstructive and irritative
voiding symptoms. The risk of urinary retention in published series is 10-15%. Voiding
symptoms persist up to 1 year following this procedure.

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.

Inclusion Criteria:

- 1) Informed consent must be obtained. 2) Men of any age 3) Diagnosis of prostate
cancer that is clinically localized 4) Patients must be eligible for permanent
prostate brachytherapy either alone or with combination of other treatments (i.e.
External beam radiation or hormonal therapy)

Exclusion Criteria:

- Refusal to participate in the study

- Prior use of alpha-blocker or anti-cholinergic medication in the treatment of
prostate hypertrophy.

- Contraindication to using an alpha-blocker

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

IPSS and sexual function QOL life

Principal Investigator

Louis Potters, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York Prostate Institue


United States: Institutional Review Board

Study ID:




Start Date:

September 2005

Completion Date:

September 2005

Related Keywords:

  • Prostate Cancer
  • Prostate
  • cancer
  • Brachytherapy
  • Alpha Blocker
  • Prostatic Neoplasms



New York Prostate InstituteOceanside, New York  11572