Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeRePEA Trial (ProSeRePEA)

Valutazione Dell'Efficacia Del Trattamento Dell'Ipertrofia Prostatica Benigna Con Serenoa Repens Estratta Con CO2 + PEA (Palmitoilethanolamide) in Monoterapia o in Combinazione Alla Tamsulosina: ProSeRePEA Trial

The objective of this study is to evaluate the efficacy of the supplement PEAPROSTIL 600 (FARMITALIA®) composed of Serenoa Repens combined with PEA in single or combined therapy with alpha-blocker in the reduction of voiding symptoms in benign prostatic hyperplasia (BPH) patients at low risk of progression to obstructing conditioning that need for surgical therapy. Any adverse events, intolerance, allergic reactions, complications related to the products used will be recorded throughout the study period.

Study Overview

• Status: Recruiting
• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia; Urinary Obstruction
• Intervention / Treatment: Drug: PEAPROSTIL 600 + Tamsulosin 0.4 mg; Drug: PEAPROSTIL 600 mg; Drug: Tamsulosin 0.4 mg

Detailed Description

Study design

Single-center 3-arm randomized prospective clinical trial.

• Arm 1: PEAPROSTIL 600 + Tamsulosin 0.4 mg
• Arm 2: PEAPROSTIL 600
• Arm 3: Tamsulosin 0.4 mg

At the time of study enrollment, each patient will be randomized into one of the 3 arms described. Randomisation will take place with a 1: 1: 1 scheme.

All the variables will be collected by a medical co-investigator of Prof. Alessandro Volpe's team during the follow-up visits at pre-established intervals of 1, 3, 6 and 12 months (respectively T1, T2, T3 and T4) and will be reported in the special data collection folder (CRF).

At 1 month (T1) 3 months (T2), 6 months (T3) and 12 months (T4):

Personal data: identification number and initials of the patient's name and surname, date of birth, telephone number and e-mail address History: International Prostate Symptoms Score questionnaire, Short Form Health Survey-36 questionnaires Physical examination: abdominal, urological including rectal examination Uroflowmetry: analysis of the morphology of the flow curve, Qmax, volume of urine emptied, post-voiding residue).

250 patients will be recruited. The sample analysis was performed by the Department of Medical, Surgical and Advanced Technologies "Ingrassia" of the University of Catania for a study power of 90% and an Alpha error of 0.05 (statistical significance). In particular, the design involves a 3-arm randomization process 1: 1: 1. Expecting a difference of at least 2 points in the International Prostate Symptoms Score questionnaire and Qmax and a standard deviation of 4. It is necessary to enroll 250 patients to obtain a statistic of 90% at a significance level of 0.05. The statistical analysis of the data collected during the study, according to an intention-to-treat procedure, will be performed using statistical software including IBM SPSS statistics version 23.0. A descriptive analysis of the patients included in the three arms will be performed using the appropriate frequency measurements and central tendency and dispersion indices. Considering a pair of the three arms at a time (1 vs. 2; 1 vs. 3; 2 vs. 3), the qualitative variables will be compared using the chi-squared test; quantitative variables will be compared by Student's t-test. The significance level will be set at p <0.05. For the variables that will be significant in the univariate analysis, multivariate analyzes will be carried out using appropriate regression models.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele Billia, MD; Phone Number: +3903213733201; Email: clinicaurologicanovara1@gmail.com
• Study Contact Backup: Name: Volpe Alessandro, MD; Phone Number: +3903213733201; Email: clinicaurologicanovara1@gmail.com

Study Locations

• Italy
  • Novara, Italy, 28100
    • Recruiting
    • Michele Billia
    • Contact: Michele Billia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• male with age> 40 years
• baseline International Prostate Symptoms Score between 8 and 14
• prostate volume ≤ 60 cc assessed by transrectal ultrasound (TRUS)
• maximum flow (Qmax at uroflowmetry) ≤ 15 ml / sec
• post voiding residue on extemporaneous ultrasound ≤ 120 ml
• Signature of informed consent for participation in the study
• ability to understand the conditions of the study and to participate in the study throughout its duration.

Exclusion Criteria:

• urinary incontinence
• overactive bladder
• neurological bladder
• malignancies in progress and which have undergone treatment in the previous 6 months
• local or systemic infections (urinary tract infection, osteomyelitis, sepsis, etc.)
• kidney failure
• macrohematuria
• bladder stones

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARM 1: PEAPROSTIL 600 mg + Tamsulosin 0.4 mg; PEAPROSTIL 600 is a food supplement based on Palmitoylethanolamide and Serenoa Repens, respectively for each sachet there are 600 mg of PEA and 320 mg of Serenoa oil. The net content of a sachet is 2.45 g and can be orodispersible without the need for the use of water. The drug does not contain gluten or lactose. • Tamsulosin 0.4 mg is a drug belonging to the category of alpha-blocker drugs used as first choice drugs (according to European Urology association guidelines) for the treatment of LUTS/BPH. The recommended dose is 0.4 mg per day (1 administration), to be taken preferably at the same time during the day, indifferently with or without meals.	Drug: PEAPROSTIL 600 + Tamsulosin 0.4 mg; PEAPROSTIL 600 mg one sachet oral daily+ Tamsulosin 0.4 mg one tablet oral daily; Other Names: PEAPROSTIL, Omnic
Active Comparator: ARM 2: PEAPROSTIL 600 mg; PEAPROSTIL 600 is a food supplement based on Palmitoylethanolamide and Serenoa Repens, respectively for each sachet there are 600 mg of PEA and 320 mg of Serenoa oil. The net content of a sachet is 2.45 g and can be orodispersible without the need for the use of water. The drug does not contain gluten or lactose.	Drug: PEAPROSTIL 600 mg; PEAPROSTIL 600 mg one sachet oral daily; Other Names: PeaProstil
Active Comparator: ARM 3: Tamsulosin 0.4 mg; Tamsulosin 0.4 mg is a drug belonging to the category of alpha-blocker drugs used as first choice drugs (according to European Urology association guidelines) for the treatment of benign prostatic hyperplasia. The recommended dose is 0.4 mg per day (1 administration), to be taken preferably at the same time during the day, indifferently with or without meals.	Drug: Tamsulosin 0.4 mg; Tamsulosin 0.4 mg one tablet oral daily; Other Names: Omnic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of treatment of combination therapy group vs tamsulosin group in International Prostate Symptoms Score questionnaire	comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of International Prostate Symptoms Score (scale 0-35) at 1,3,6 and 12 months. (0 point no symptoms, 35 points many symptoms)	1 year
Efficacy of treatment of combination therapy group vs tamsulosin group in Quality of Life questionnaire	comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of Quality of life (0-6 points) at 1,3,6 and 12 months (0 point good quality of life, 6 points bad quality of life)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of Short Form Health Survey-36 questionnaires	comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of Short Form Health Survey-36 (36 questions) at 1,3,6 and 12 months	1 year
Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of uroflowmetry with maximum urinary flow (ml/s)	comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of maximum urinary flow (ml/s) at 1,3,6 and 12 months	1 year
Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of post voided volume (ml)	comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of post voided volume (ml) at 1,3,6 and 12 months	1 year
Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of prostate volume (gr)	comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of prostate volume (gr) at 6 and 12 months	1 year
Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of International Prostate Symptoms Score	comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of International Prostate Symptoms Score (scale 0-35) at 1,3,6 and 12 months. (0 point no symptoms, 35 points many symptoms)	1 year
Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of Quality of life	comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of Quality of life (QoL) (0-6 points) at 1,3,6 and 12 months (0 point good quality of life, 6 points bad quality of life)	1 year
Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of Short Form Health Survey-36 questionnaires	comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of Short Form Health Survey-36 (36 questions) at 1,3,6 and 12 months	1 year
Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of uroflowmetry with maximum urinary flow (ml/s)	comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of maximum urinary flow (ml/s) at 1,3,6 and 12 months	1 year
Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of post voided volume (ml)	comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of post voided volume (ml) at 1,3,6 and 12 months	1 year
Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of prostate volume (gr)	comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of prostate volume (gr) at 6 and 12 months	1 year

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
• Investigators: Principal Investigator: Michele Billia, MD, SCDU Urologia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: BPH; benign prostatic hypertrophy
• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: ProSeRePEA trial, v.01

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
• product manufactured in and exported from the U.S.: No