NCT00201630

Brief Summary

To asess the efficacy of Uroxatrol, an alpha blocker in men undergoing prostate brachytherapy to treat prostate cancer, and whether the use of Uroxatrol in advance of the brachytherapy is better or not than starting it on the day of surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

August 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Prostate Cancer

Keywords

ProstatecancerBrachytherapyAlpha Blocker

Outcome Measures

Primary Outcomes (1)

  • IPSS and sexual function QOL life

Secondary Outcomes (1)

  • Safety and tolerance

Interventions

Uroxatrol (drug)DRUG

Eligibility Criteria

Age0 Years+
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \) Informed consent must be obtained. 2) Men of any age 3) Diagnosis of prostate cancer that is clinically localized 4) Patients must be eligible for permanent prostate brachytherapy either alone or with combination of other treatments (i.e. External beam radiation or hormonal therapy)

You may not qualify if:

  • Refusal to participate in the study
  • Prior use of alpha-blocker or anti-cholinergic medication in the treatment of prostate hypertrophy.
  • Contraindication to using an alpha-blocker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Prostate Institute

Oceanside, New York, 11572, United States

Location

Related Publications (1)

  • Lefevre-Borg F, O'Connor SE, Schoemaker H, Hicks PE, Lechaire J, Gautier E, Pierre F, Pimoule C, Manoury P, Langer SZ. Alfuzosin, a selective alpha 1-adrenoceptor antagonist in the lower urinary tract. Br J Pharmacol. 1993 Aug;109(4):1282-9. doi: 10.1111/j.1476-5381.1993.tb13762.x.

    PMID: 8104650BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Interventions

alfuzosinPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Louis Potters, MD

    New York Prostate Institue

    STUDY CHAIR

Central Study Contacts

Louis Potters, MD

CONTACT

516-632-3370pottersl@yahoo.com

Betsy Guzman

CONTACT

516-632-3370bguzman@snch.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 1, 2005

Study Completion

September 1, 2005

Last Updated

September 20, 2005

Record last verified: 2005-08

Locations

US(1)