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)

Benign Prostatic Hyperplasia Clinical Trial

— PROSPERITY  

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04831476
• Other study ID #: 2020-DTM-EL-126/133
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: February 2023
• Source: Elpen Pharmaceutical Co. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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®)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1296
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Other:
• Patients with Benign Prostate Hyperplasia
patients with benign prostatic hyperplasia under fixed dose comb?nation treatment with dutasteride and tamsulosin

Locations

Country	Name	City	State
Greece	Laikon Hospital of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Elpen Pharmaceutical Co. Inc.

Country where clinical trial is conducted

Greece, 

References & Publications (23)

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/s0302-2 — View Citation

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. — View Citation

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. — View Citation

Ekman P. The prostate as an endocrine organ: androgens and estrogens. Prostate Suppl. 2000;10:14-8. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Helga Fritch, Wolfgang Kühnel. ???e???d?? ?e????af???? ??at?µ????. s.l. : ?.?. ?as?a??d??, 2009.

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 availa — View Citation

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. — View Citation

Lepor H. Alpha 1-adrenoceptor selectivity: clinical or theoretical benefit? Br J Urol. 1995 Jul;76 Suppl 1:57-61. No abstract available. — View Citation

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. — View Citation

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 pla — View Citation

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. — View Citation

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.

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 — View Citation

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. — View Citation

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. — View Citation

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.1476-5381.199 — View Citation

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. — View Citation

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, Sturke — View Citation

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/s — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of AEs (PROSPERITY I&II)	The recording of Adverse Events (Adverse Events, SA) if they occur during the study.	3-6 months