Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer

NCT00244309 | Completed Phase 3 DMC

• 2 other identifiers: CASE14804GSK106046 (formerly 103988)
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.

Conditions

Prostate Cancer

Keywords

brachytherapy; urinary symptoms

Outcome Measures

Primary Outcomes (1)

• AUA score will be used to assess severity of urinary symptoms. All patients will be contacted weekly by telephone for 12 weeks then monthly postoperatively to get their AUA score. A total of 21 AUA scores postoperatively.

Secondary Outcomes (1)

• Use of intermittent self-catheterization

Interventions

tamsulosin and/or dutasteride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is eligible for a prostate implant
• Patient is greater than 18 years of age
• Patient is able to give informed consent
• Patient does not currently take Flomax, Dutasteride or Finasteride
• Patient does not have a known hypersensitivity reaction to Flomax or Dutasteride

You may not qualify if:

• Patients who have a known hypersensitivity reaction to tamsulosin, dutasteride or finasteride and those patients who are already on any prior to prostate implantation
• Patients who are taking a PDE-5 inhibitor including sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra) are ineligible to participate unless they are willing to discontinue using those drugs one week prior to their implant and for three months after the implant

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (17)

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MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jay P Ciezki, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 24, 2005
• First Posted: October 26, 2005
• Study Start: November 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: May 4, 2011

Record last verified: 2011-05

Locations

US (1)