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:
Collaborator:
Sanofi
Information provided by:
Dattoli Cancer Center and Brachytherapy Research Institute
ClinicalTrials.gov Identifier:
NCT00264017
First received: December 6, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 21, 2014