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) (PROSPERITY)

A Non Interventional Post Authorisation Multicenter Study to Evaluate the Disease Control (Benign Prostate Hyperplasia Control) and Quality of Life (QoL) Following the 6-months Combination Treatment With Dutasteride and Tamsulosin. PROSPERITY Group of Studies (I&II).

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®)

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Other: Patients with Benign Prostate Hyperplasia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1296

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Laikon Hospital of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult males who based on physician's recommedations will receive

DINAPLEX®- Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride (equivalent to 0.367 mg tamsulosin) Tamsulosin hydrochloride Tamsulosin binds selectively and competitively to postsynaptic α1A adrenergic receptors and to a lesser extent to α1D adrenergic receptors. It relaxes the smooth muscles of the prostate and urethra. By relaxing the smooth muscle fibers of the bladder sphincter, it relieves obstructive effects and increases urine flow. It has little antihypertensive effect.

Doutasteride Dutasteride lowers circulating dihydrotestosterone (DHT) levels by inhibiting the 5a-reductase isoenzymes type I and II, which are responsible for converting testosterone to DHT. The effect of dutasteride on DHT levels is dose-dependent and is observed within 1-2 weeks (85% and 90% reduction respectively).

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of disease control (BPH), PROSPERITY I Evaluation of quality of life. PROSPERITY II	The change in the overall score (questions 1-7) of the IPSS (International Prostate Symptom Score) questionnaire. PROSPERITY I. The change in the score of the question related to quality of life, of the IPSS questionnaire. PROSPERITY II	3-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of disease control (BPH), PROSPERITY II.	The change in the overall score (questions 1-7) of the IPSS (International Prostate Symptom Score) questionnaire. PROSPERITY II.	3-6 months
U/S measurement. PROSPERITY I&II	The change in the volume of the prostate and the change in the volume of the remaining urine (measurement by ultrasound).	3-6 months
Number of AEs (PROSPERITY I&II)	The recording of Adverse Events (Adverse Events, SA) if they occur during the study.	3-6 months

Collaborators and Investigators

• Sponsor: Elpen Pharmaceutical Co. Inc.

Publications and helpful links

General Publications

• 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.
• Helga Fritch, Wolfgang Kühnel. Εγχειρίδιο Περιγραφικής Ανατομικής. s.l. : Π.Χ. Πασχαλίδης, 2009.
• 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.
• 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.
• Ekman P. The prostate as an endocrine organ: androgens and estrogens. Prostate Suppl. 2000;10:14-8. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Lepor H. Alpha 1-adrenoceptor selectivity: clinical or theoretical benefit? Br J Urol. 1995 Jul;76 Suppl 1:57-61. No abstract available.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Benign Prostate Hyperplasia; IPSS (International Prostate Symptom Score); LUTS (Lower Urinary Tract Symptoms)
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 2020-DTM-EL-126/133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No