Prostate Cancer Patients Undergoing External Radiation and Seed ImplantationNCT00264017
Palladium-103 Seed Implant and Single Daily Dosing of Uroxatral Vs. Twice Daily Dosing of Flomax- A 3 Month Retrospective Efficacy Analysis
An observational study of Prostate Cancer Patients Undergoing External Radiation and Seed Implantation, run by Dattoli Cancer Center and Brachytherapy Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer Patients Undergoing External Radiation and Seed Implantation
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Nov 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dattoli Cancer Center and Brachytherapy Research Institute
Sarasota, Florida, 34237
About this study
Official title: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Patients Undergoing External Radiation and Seed ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Dattoli Cancer Center and Brachytherapy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Michael J Dattoli, MD, Principal investigator, Dattoli Cancer Center and Brachytherapy Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264017
- Sponsor's protocol ID
- L0087
- Status last verified
- Nov 2005
- First submitted
- 6 Dec 2005
- Last updated
- 12 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palladium-103 Seed Implant and Single Daily Dosing of Uroxatral Vs Twice Daily Dosing of Flomax-A 3 Month Retrospective Efficacy Analysis
- ClinicalTrials.gov ID
- NCT00264017
- Acronym / sponsor ID
- L0087
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Dattoli Cancer Center and Brachytherapy Research InstituteUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Nov 2005
- Study completion
- Nov 2005
- First posted
- 12 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2005.
Related trials for Prostate Cancer Patients Undergoing External Radiation and Seed Implantation
Recruiting
Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions
Prostate Cancer Patients Undergoing External Radiation and Seed Implantation, High Risk Localised Prostate Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Dattoli, MD principal investigator
Dattoli Cancer Center and Brachytherapy Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer Patients Undergoing External Radiation and Seed Implantation, run by Dattoli Cancer Center and Brachytherapy Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2005.