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Prostate CancerPhase 3NCT00201630

Prophylactic Vs. Therapeutic Use of Uroxatrol in Men Undergoing Brachytherapy

A Phase 3 study testing Uroxatrol (drug) in people with Prostate Cancer, run by New York Prostate Institute at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To asess the efficacy of Uroxatrol, an alpha blocker in men undergoing prostate brachytherapy to treat prostate cancer, and whether the use of Uroxatrol in advance of the brachytherapy is better or not than starting it on the day of surgery. Read more about this study

Who is it for?
Ages 0 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
Uroxatrol (drug)
How many people
150 participants
Where
1 siteUnited States
Study dates
Sep 2005to Sep 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 0 years and older
  • Men only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Louis Potters, MD contact

516-632-3370

pottersl@yahoo.com

Betsy Guzman contact

516-632-3370

bguzman@snch.org

United States1 site
  • New York Prostate Institute

    Oceanside, New York, 11572

    Betsy Guzman, 516-632-3370, bguzman@snch.org

    Louis Potters, MD

Other trials in United States

About this study

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

To asess the efficacy of Uroxatrol, an alpha blocker in men undergoing prostate brachytherapy to treat prostate cancer, and whether the use of Uroxatrol in advance of the brachytherapy is better or not than starting it on the day of surgery.

Read the detailed description

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.

Conditions
Prostate Cancer
Being tested
Uroxatrol (drug)
Keywords
Prostate, cancer, Brachytherapy, Alpha Blocker
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Uroxatrol (drug)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IPSS and sexual function QOL life

Secondary outcomes (1)
  1. Safety and tolerance

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Study completionSep 2005

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00201630
Sponsor's protocol ID
04-005
Status last verified
Aug 2005
First submitted
12 Sep 2005
Last updated
20 Sep 2005
Results posted
No

Publications

  • 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.

    PubMed 8104650

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Uroxatrol (drug) in people with Prostate Cancer, run by New York Prostate Institute at 1 site 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Sep 2005. 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 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Louis Potters, MD (516-632-3370, pottersl@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IPSS and sexual function QOL life. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00201630, which also lists 1 linked publication.

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 Sep 2005.

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