NCT04831476

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)

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).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,296 (actual)
• Sponsor: Elpen Pharmaceutical Co. Inc. · Industry
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: —

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®)

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
OTHER	Patients with Benign Prostate Hyperplasia	patients with benign prostatic hyperplasia under fixed dose combΙnation treatment with dutasteride and tamsulosin

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2021-04-05
• Last updated: 2023-10-18

Locations

1 site across 1 country: Greece