- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00264017
Palladium-103 Seed Implant and Single Daily Dosing of Uroxatral Vs. Twice Daily Dosing of Flomax- A 3 Month Retrospective Efficacy Analysis
December 6, 2005 updated by: Dattoli Cancer Center and Brachytherapy Research Institute
Palladium-103 Seed Implant and Single Daily Dosing of Uroxatral Vs Twice Daily Dosing of Flomax-A 3 Month Retrospective Efficacy Analysis
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Sarasota, Florida, United States, 34237
- Dattoli Cancer Center and Brachytherapy Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Retrospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael J Dattoli, MD, Dattoli Cancer Center and Brachytherapy Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
December 6, 2005
First Submitted That Met QC Criteria
December 6, 2005
First Posted (Estimate)
December 12, 2005
Study Record Updates
Last Update Posted (Estimate)
December 12, 2005
Last Update Submitted That Met QC Criteria
December 6, 2005
Last Verified
November 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L0087
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.