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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00264017
First Posted: December 12, 2005
Last Update Posted: December 12, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by:
Dattoli Cancer Center and Brachytherapy Research Institute
  Purpose
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.

Condition
Prostate Cancer Patients Undergoing External Radiation and Seed Implantation

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: Palladium-103 Seed Implant and Single Daily Dosing of Uroxatral Vs Twice Daily Dosing of Flomax-A 3 Month Retrospective Efficacy Analysis

Resource links provided by NLM:


Further study details as provided by Dattoli Cancer Center and Brachytherapy Research Institute:

Estimated Enrollment: 60
Study Start Date: November 2005
Estimated Study Completion Date: November 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264017


Locations
United States, Florida
Dattoli Cancer Center and Brachytherapy Research Institute
Sarasota, Florida, United States, 34237
Sponsors and Collaborators
Dattoli Cancer Center and Brachytherapy Research Institute
Sanofi
Investigators
Principal Investigator: Michael J Dattoli, MD Dattoli Cancer Center and Brachytherapy Research Institute
  More Information

ClinicalTrials.gov Identifier: NCT00264017     History of Changes
Other Study ID Numbers: L0087
First Submitted: December 6, 2005
First Posted: December 12, 2005
Last Update Posted: December 12, 2005
Last Verified: November 2005

Additional relevant MeSH terms:
Alfuzosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents