PROSPERITY: 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 as Well as Their qualitY of Life

• Sponsor: Elpen Pharmaceutical Co. Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04831476
• Collaborator: (none)
• Enrollment: 990
• Location: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 70.9

Study Details

Study Description

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®)

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	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 Design

• Study Type: Observational
• Anticipated Enrollment: 990 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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 as Well as Their qualitY of Life.
• Actual Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Outcome Measures

Primary Outcome Measures

1. Evaluation of disease control (BPH) [3-6 months]

   The change in the overall score (questions 1-7) of the IPSS (International Prostate Symptom Score) questionnaire.

Secondary Outcome Measures

1. IPSS question 7 score [3-6 months]

   The change in the score of the question related to quality of life, of the IPSS questionnaire.

2. U/S measurement [3-6 months]

   The change in the volume of the prostate and the change in the volume of the remaining urine (measurement by ultrasound).

3. Number of AEs [3-6 months]

   The recording of Adverse Events (Adverse Events, SA) if they occur during the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Male

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laikon Hospital of Athens	Athens		Greece

Sponsors and Collaborators

• Elpen Pharmaceutical Co. Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Elpen Pharmaceutical Co. Inc.
• ClinicalTrials.gov Identifier: NCT04831476
• Other Study ID Numbers: 2020-DTM-EL-126/133
• First Posted: Apr 5, 2021
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elpen Pharmaceutical Co. Inc.: Benign Prostate Hyperplasia; IPSS (International Prostate Symptom Score); LUTS (Lower Urinary Tract Symptoms)
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia

Study Results

No Results Posted as of Jul 13, 2022