Α Prospective Observational Study for the Evaluation of Disease Control and Quality of Life in Patients With Benign PROStatic hyPERplasia Under Fixed Dose combΙnaTion Treatment With Dutasteride and Tamsulosin . PROSPERITY Group of Studies (I&II)
NCT ID: NCT04831476
Last Updated: 2023-10-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
1296 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-09-01
Study Completion Date
2022-10-31
Brief Summary
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Investigation of the efficacy and safety of the stable combination of dutasteride and tamsulosin (Dinaplex®) in the Greek population as well as the evaluation of the quality of life of patients with benign prostatic hyperplasia (BPH) in treatment with a stable combination of dutasteride and tamsulosin (Dinaplex®)
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Detailed Description
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Combination therapy with the 5-α reductase inhibitor, dutasteride, and the α-blocker, tamsulosin, in men with moderate to severe benign prostatic hyperplasia and prostate enlargement, was studied in the Combination of Avodart ™ and Tamsulosin (CombAT) which was a four-year, global, multicenter, randomized, double-blind, parallel design (3 arms) study. The aim of the study was to investigate the benefits of combination therapy (dutasteride-tamsulosin) compared to monotherapy in terms of improvement of symptoms and long-term results (AUR and surgery), in men with moderate to severe BPH. The primary endpoint in the two years since the start of the study was the change in the IPSS score, while the primary endpoint, after four years of treatment, was the time until the long-term results manifested (i.e. AUR or CF surgery) as well as the percentage of participants who were led to them. Patients were at least 50 years old with a prostate tumor ≥30 cm3 and a PSA level ≥ 1.5 ng / mL. 4838 men (39) participated in this study.
Conditions
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Benign Prostatic Hyperplasia
Study Design
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Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Interventions
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Patients with Benign Prostate Hyperplasia
patients with benign prostatic hyperplasia under fixed dose combΙnation treatment with dutasteride and tamsulosin
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Adult male patient with moderate to severe BPH symptoms receiving either monotherapy, dual medication as monoproducts or other stable combination and not responding adequately to treatment.
* Adult male patient with BPH who has fully understood the study procedures and has signed a consent form after information.
* Adult male patient with BPH who has fully understood the study procedures and has signed a consent form after information.
Exclusion Criteria
* Patient who does not meet the criteria for taking the study drug (s), according to the Summary of Product Characteristics of each drug in the study.
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Elpen Pharmaceutical Co. Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Laikon Hospital of Athens
Athens, , Greece
Site Status
Countries
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Greece
References
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World Medical Association Declaration of Helsinki. Ethical principles for Medical Research Involving Human Subjects, Helsinki 1964, amended in Tokyo 1975, Venice 1983, Hong Kong 1989, South Africa 1996, Edinburgh 2000, and Seoul 2008.
Reference Type
BACKGROUND
Helga Fritch, Wolfgang Kühnel. Εγχειρίδιο Περιγραφικής Ανατομικής. s.l. : Π.Χ. Πασχαλίδης, 2009.
Reference Type
RESULT
Presti JC Jr. (2000) Neoplasms of the prostate gland, in Smith's General Urology, 15th Edition, Tanagho EA and McAninch JW, Editors. Lange Medical Books: New York, USA. p. 399-421.
Reference Type
RESULT
Shibata K, Hirasawa A, Moriyama N, Kawabe K, Ogawa S, Tsujimoto G. Alpha 1a-adrenoceptor polymorphism: pharmacological characterization and association with benign prostatic hypertrophy. Br J Pharmacol. 1996 Jul;118(6):1403-8. doi: 10.1111/j.1476-5381.1996.tb15552.x.
Reference Type
RESULT
Ekman P. The prostate as an endocrine organ: androgens and estrogens. Prostate Suppl. 2000;10:14-8. No abstract available.
Reference Type
RESULT
Verhamme KM, Dieleman JP, Bleumink GS, van der Lei J, Sturkenboom MC, Artibani W, Begaud B, Berges R, Borkowski A, Chappel CR, Costello A, Dobronski P, Farmer RD, Jimenez Cruz F, Jonas U, MacRae K, Pientka L, Rutten FF, van Schayck CP, Speakman MJ, Sturkenboom MC, Tiellac P, Tubaro A, Vallencien G, Vela Navarrete R; Triumph Pan European Expert Panel. Incidence and prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia in primary care--the Triumph project. Eur Urol. 2002 Oct;42(4):323-8. doi: 10.1016/s0302-2838(02)00354-8.
Reference Type
RESULT
Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status. J Urol. 1999 Oct;162(4):1301-6.
Reference Type
RESULT
Marberger MJ, Andersen JT, Nickel JC, Malice MP, Gabriel M, Pappas F, Meehan A, Stoner E, Waldstreicher J. Prostate volume and serum prostate-specific antigen as predictors of acute urinary retention. Combined experience from three large multinational placebo-controlled trials. Eur Urol. 2000 Nov;38(5):563-8. doi: 10.1159/000020356.
Reference Type
RESULT
Clifford GM, Logie J, Farmer RD. How do symptoms indicative of BPH progress in real life practice? The UK experience. Eur Urol. 2000;38 Suppl 1:48-53. doi: 10.1159/000052401.
Reference Type
RESULT
Lowe FC. Goals for benign prostatic hyperplasia therapy. Urology. 2002 Feb;59(2 Suppl 1):1-2. doi: 10.1016/s0090-4295(01)01554-0. No abstract available.
Reference Type
RESULT
Sanda MG, Beaty TH, Stutzman RE, Childs B, Walsh PC. Genetic susceptibility of benign prostatic hyperplasia. J Urol. 1994 Jul;152(1):115-9. doi: 10.1016/s0022-5347(17)32831-8.
Reference Type
RESULT
Sidney S, Quesenberry CP Jr, Sadler MC, Guess HA, Lydick EG, Cattolica EV. Incidence of surgically treated benign prostatic hypertrophy and of prostate cancer among blacks and whites in a prepaid health care plan. Am J Epidemiol. 1991 Oct 15;134(8):825-9. doi: 10.1093/oxfordjournals.aje.a116157.
Reference Type
RESULT
Choi J, Ikeguchi EF, Lee SW, Choi HY, Te AE, Kaplan SA. Is the higher prevalence of benign prostatic hyperplasia related to lower urinary tract symptoms in Korean men due to a high transition zone index? Eur Urol. 2002 Jul;42(1):7-11. doi: 10.1016/s0302-2838(02)00222-1.
Reference Type
RESULT
Geller J, Sionit L, Partido C, Li L, Tan X, Youngkin T, Nachtsheim D, Hoffman RM. Genistein inhibits the growth of human-patient BPH and prostate cancer in histoculture. Prostate. 1998 Feb 1;34(2):75-9. doi: 10.1002/(sici)1097-0045(19980201)34:23.0.co;2-i.
Reference Type
RESULT
Chyou PH, Nomura AM, Stemmermann GN, Hankin JH. A prospective study of alcohol, diet, and other lifestyle factors in relation to obstructive uropathy. Prostate. 1993;22(3):253-64. doi: 10.1002/pros.2990220308.
Reference Type
RESULT
Ryl A, Rotter I, Miazgowski T, Slojewski M, Dolegowska B, Lubkowska A, Laszczynska M. Metabolic syndrome and benign prostatic hyperplasia: association or coincidence? Diabetol Metab Syndr. 2015 Oct 29;7:94. doi: 10.1186/s13098-015-0089-1. eCollection 2015.
Reference Type
RESULT
Peters TJ, Donovan JL, Kay HE, Abrams P, de la Rosette JJ, Porru D, Thuroff JW. The International Continence Society "Benign Prostatic Hyperplasia" Study: the botherosomeness of urinary symptoms. J Urol. 1997 Mar;157(3):885-9.
Reference Type
RESULT
Scarpa RM. Lower urinary tract symptoms: what are the implications for the patients? Eur Urol. 2001;40 Suppl 4:12-20. doi: 10.1159/000049890.
Reference Type
RESULT
Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991 Aug 24;338(8765):469-71. doi: 10.1016/0140-6736(91)90543-x.
Reference Type
RESULT
Lepor H. Alpha 1-adrenoceptor selectivity: clinical or theoretical benefit? Br J Urol. 1995 Jul;76 Suppl 1:57-61. No abstract available.
Reference Type
RESULT
Welch G, Kawachi I, Barry MJ, Giovannucci E, Colditz GA, Willett WC. Distinction between symptoms of voiding and filling in benign prostatic hyperplasia: findings from the Health Professionals Follow-up Study. Urology. 1998 Mar;51(3):422-7. doi: 10.1016/s0090-4295(97)00626-2.
Reference Type
RESULT
International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. No abstract available.
Reference Type
RESULT
Epstein M; International Society of Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2005 Aug;14(8):589-95. doi: 10.1002/pds.1082. No abstract available.
Reference Type
RESULT
Other Identifiers
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2020-DTM-EL-126/133
Identifier Type: -
Identifier Source: org_study_id
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