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BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)

NCT01520441 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2015-06-03

No results posted yet for this study

Summary

This is a pilot study examining biological endpoints in men with localized prostate cancer who are scheduled to have radical prostatectomies and men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A (BoNT-A) injection. Patients will serve as their own controls by receiving BoNT-A injections into the right peripheral and transition zones and sham saline injections into the left peripheral and transition zones.

Conditions

  • Prostate Cancer
  • Benign Prostatic Hyperplasia
  • Enlarged Prostate With Lower Urinary Tract Symptoms (LUTS)

Interventions

DRUG

BOTOX

A total of 200 units of BoNT-A diluted in 4ml of preservative free saline will be injected into the right prostate lobe (i.e. transition and peripheral zones). A similar injection template with 1.0ml volume injections of saline will be injected into the left prostate lobe (2 injections in transition zone, 2 injections in peripheral zone for total volume of 4ml).

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Gusatavo E. Ayala, MD · University of Texas Houston Health Science Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01520441 on ClinicalTrials.gov