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Palladium-103 Seed Implant and Single Daily Dosing of Uroxatral Vs. Twice Daily Dosing of Flomax- A 3 Month Retrospective Efficacy Analysis

NCT ID: NCT00264017

Last Updated: 2005-12-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Study Completion Date

2005-11-30

Brief Summary

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In the past ten years, newer drugs with more selective affinity for the alpha-receptor have been introduced. Alfuzosin (Uroxatral) and Tamulosin(Flomax are two second generation alpha-blockers. In the course of our clinical proctice, both drugs have been used routinely. This retrospective comparison is intended to be a priliminary comparison of their effectiveness and side effects.

Detailed Description

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Conditions

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Prostate Cancer Patients Undergoing External Radiation and Seed Implantation

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Males age 45-80 years
* Diagnosis of prostate cancer
* Status post IMRT and Palladium-103 seed implantation and initiated alpha blocker therapy with alfuzosin10mg daily or tamulosin 0.4mg bid at time of seed implantation
* Baseline AUA score\< or =12
* May be on antiandrogenand/or alpha reductase therapy
* Patients receiving IMRT followed by Palladium-103 Brachytherapy implantation as the primary therapy for prostate cancer with curatives intent -

Exclusion Criteria

* History of insulin-dependent diabetes
* Uncontrolled hypertention
* History of symptomtic hypotension (including syncope and dizziness)
* Pre-existing obstructive uropathy based on history of BPH and or Acute Urinary Retention
* Pre-existing prostatitis either continuous or intermittent
* Concurrent use of any other anticholinergics
* previous or concurrent usage of LHRH agonist
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Dattoli Cancer Center and Brachytherapy Research Institute

OTHER

Sponsor Role lead

Principal Investigators

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Michael J Dattoli, MD

Role: PRINCIPAL_INVESTIGATOR

Dattoli Cancer Center and Brachytherapy Research Institute

Locations

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Dattoli Cancer Center and Brachytherapy Research Institute

Sarasota, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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L0087

Identifier Type: -

Identifier Source: org_study_id