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.

First Received on December 6, 2005. No Changes Posted

Sponsor:	Dattoli Cancer Center and Brachytherapy Research Institute
Collaborator:	Sanofi-Aventis
Information provided by:	Dattoli Cancer Center and Brachytherapy Research Institute
ClinicalTrials.gov Identifier:	NCT00264017

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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

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

Ages Eligible for Study:	45 Years to 80 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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-Aventis

Investigators

Principal Investigator:

Michael J Dattoli, MD

Dattoli Cancer Center and Brachytherapy Research Institute

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00264017 History of Changes
Other Study ID Numbers:	L0087
Study First Received:	December 6, 2005
Last Updated:	December 6, 2005
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Alfuzosin
Antihypertensive Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012