Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer
NCT ID: NCT00244309
Last Updated: 2011-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
348 participants
INTERVENTIONAL
2005-11-30
2006-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation
NCT00805701
Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
NCT00090103
Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
NCT00701779
Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for Brachytherapy
NCT00866554
Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement
NCT01294592
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tamsulosin and/or dutasteride
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Case Comprehensive Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jay P Ciezki, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GSK106046 (formerly 103988)
Identifier Type: -
Identifier Source: secondary_id
CASE14804
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.