Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer
May 3, 2011 updated by: Case Comprehensive Cancer Center
A Randomized Trial of Tamsulosin and/or Dutasteride Versus Placebo to Relieve Urinary Symptoms After Brachytherapy for the Treatment of Localized Prostate Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Image-guided transperineal permanent prostate brachytherapy (PI) is an accepted curative treatment option for patients with early stage prostate cancer.
The most severe side effect of PI is urinary retention requiring intermittent self-catheterization (ISC).
This study will assess the ability of pharmacologic intervention to ameliorate the post-operative side effect of PI.
The use of both tamsulosin and dutasteride is proposed to have benefit in reducing urinary symptom score and in reducing the rate of intermittent self-catheterization for patients with prostate adenocarcinoma after prostate implant.
Study Type
Interventional
Enrollment (Anticipated)
348
Phase
- Phase 3
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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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Use of intermittent self-catheterization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jay P Ciezki, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ragde H, Blasko JC, Grimm PD, Kenny GM, Sylvester JE, Hoak DC, Landin K, Cavanagh W. Interstitial iodine-125 radiation without adjuvant therapy in the treatment of clinically localized prostate carcinoma. Cancer. 1997 Aug 1;80(3):442-53. doi: 10.1002/(sici)1097-0142(19970801)80:33.0.co;2-x.
- Ragde H, Korb LJ, Elgamal AA, Grado GL, Nadir BS. Modern prostate brachytherapy. Prostate specific antigen results in 219 patients with up to 12 years of observed follow-up. Cancer. 2000 Jul 1;89(1):135-41.
- Blasko JC, Ragde H, Grimm PD. Transperineal ultrasound-guided implantation of the prostate: morbidity and complications. Scand J Urol Nephrol Suppl. 1991;137:113-8.
- Kleinberg L, Wallner K, Roy J, Zelefsky M, Arterbery VE, Fuks Z, Harrison L. Treatment-related symptoms during the first year following transperineal 125I prostate implantation. Int J Radiat Oncol Biol Phys. 1994 Mar 1;28(4):985-90. doi: 10.1016/0360-3016(94)90119-8.
- Terk MD, Stock RG, Stone NN. Identification of patients at increased risk for prolonged urinary retention following radioactive seed implantation of the prostate. J Urol. 1998 Oct;160(4):1379-82.
- Benoit RM, Naslund MJ, Cohen JK. A comparison of complications between ultrasound-guided prostate brachytherapy and open prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2000 Jul 1;47(4):909-13. doi: 10.1016/s0360-3016(00)00506-x.
- Lee N, Wuu CS, Brody R, Laguna JL, Katz AE, Bagiella E, Ennis RD. Factors predicting for postimplantation urinary retention after permanent prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1457-60. doi: 10.1016/s0360-3016(00)00784-7.
- Bruno JF, Whittaker J, Song JF, Berelowitz M. Molecular cloning and sequencing of a cDNA encoding a human alpha 1A adrenergic receptor. Biochem Biophys Res Commun. 1991 Sep 30;179(3):1485-90. doi: 10.1016/0006-291x(91)91740-4.
- Ramarao CS, Denker JM, Perez DM, Gaivin RJ, Riek RP, Graham RM. Genomic organization and expression of the human alpha 1B-adrenergic receptor. J Biol Chem. 1992 Oct 25;267(30):21936-45.
- Lepor H. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Urology. 1998 Jun;51(6):892-900. doi: 10.1016/s0090-4295(98)00126-5.
- Lepor H. Long-term evaluation of tamsulosin in benign prostatic hyperplasia: placebo-controlled, double-blind extension of phase III trial. Tamsulosin Investigator Group. Urology. 1998 Jun;51(6):901-6. doi: 10.1016/s0090-4295(98)00127-7.
- Chapple CR, Wyndaele JJ, Nordling J, Boeminghaus F, Ypma AF, Abrams P. Tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist. A meta-analysis of two randomized, placebo-controlled, multicentre studies in patients with benign prostatic obstruction (symptomatic BPH). European Tamsulosin Study Group. Eur Urol. 1996;29(2):155-67.
- Schulman CC, Cortvriend J, Jonas U, Lock TM, Vaage S, Speakman MJ. Tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist. Analysis of a multinational, multicentre, open-label study assessing the long-term efficacy and safety in patients with benign prostatic obstruction (symptomatic BPH). European Tamsulosin Study Group. Eur Urol. 1996;29(2):145-54.
- Prosnitz RG, Schneider L, Manola J, Rocha S, Loffredo M, Lopes L, D'Amico AV. Tamsulosin palliates radiation-induced urethritis in patients with prostate cancer: results of a pilot study. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):563-6. doi: 10.1016/s0360-3016(99)00246-1.
- Elshaikh MA, Angermeier K, Ulchaker JC, Klein EA, Chidel MA, Mahoney S, Wilkinson DA, Reddy CA, Ciezki JP. Effect of anatomic, procedural, and dosimetric variables on urinary retention after permanent iodine-125 prostate brachytherapy. Urology. 2003 Jan;61(1):152-5. doi: 10.1016/s0090-4295(02)02142-8.
- Nag S, Beyer D, Friedland J, Grimm P, Nath R. American Brachytherapy Society (ABS) recommendations for transperineal permanent brachytherapy of prostate cancer. Int J Radiat Oncol Biol Phys. 1999 Jul 1;44(4):789-99. doi: 10.1016/s0360-3016(99)00069-3.
- Nag S, Bice W, DeWyngaert K, Prestidge B, Stock R, Yu Y. The American Brachytherapy Society recommendations for permanent prostate brachytherapy postimplant dosimetric analysis. Int J Radiat Oncol Biol Phys. 2000 Jan 1;46(1):221-30. doi: 10.1016/s0360-3016(99)00351-x.
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
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
October 24, 2005
First Submitted That Met QC Criteria
October 24, 2005
First Posted (Estimate)
October 26, 2005
Study Record Updates
Last Update Posted (Estimate)
May 4, 2011
Last Update Submitted That Met QC Criteria
May 3, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- 5-alpha Reductase Inhibitors
- Tamsulosin
- Dutasteride
Other Study ID Numbers
- CASE14804
- GSK106046 (formerly 103988)
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.