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)

Completed

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT04831476
• Lead Sponsor: Elpen Pharmaceutical Co. Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-05
• Study Start: 2021-09-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1296

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of disease control (BPH), PROSPERITY I Evaluation of quality of life. PROSPERITY II	3-6 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Laikon Hospital of Athens; 🇬🇷 Athens, Greece