Plain English Summary
Background and study aims
Benign prostatic hyperplasia (BPH) (prostate enlargement) and lower urinary tract symptoms (LUTS) are common conditions that affect older men. The prostate is a small gland found inside the pelvis of men between the penis and the bladder. If it becomes enlarged, it can put pressure on the bladder and interfere with urinating. More common symptoms of prostate enlargement include a frequent need to urinate, difficulty starting to urinate and problems in fully emptying the bladder. It is not known why some men’s prostate becomes enlarged, but it’s thought to be related to hormonal changes as a man gets older. Some studies have shown that chronic inflammation of the prostate can lead to enlargement of the prostate cells and development of BPH. There are some drug treatments available which help to block the inflammation of prostate cells and relieve symptoms of BPH. Also, there is some evidence that combining certain drugs can relieve symptoms of BPH better than standard single drug treatments. One treatment available for BPH is Tadalafil® tablets, which are said to help reduce symptoms of BPH and improve urine flow, but how well it works is still controversial. The aim of this study is to test a new combination drug called Profluss® to see if it works better at relieving the symptoms of BPH and LUTS than Tadalafil®.
Who can participate?
Men aged 50-75 with prostate enlargement.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are given Profluss® tablets and take one a day for 6 months. Those in group 2 (control group) are given Tadalafil® tablets and take one a day for 6 months. At the start of the study, all participants complete questionnaires and have urine tests used to assess BPH, then again at 1, 3 and 6 months.
What are the possible benefits and risks of participating?
Participating in this study may help patients reduce symptoms of BPH and LUTS. There is a possible risk of side effects related to the prescribed drugs, however all risks are fully discussed with participants before the start of the trial.
Where is the study run from?
University of Catania, G. Rodolico Hospital (Universitaria Policlinico di Catania - POG Rodolico) and 27 other hospitals in Italy
When is the study starting and how long is it expected to run for?
May 2015 to November 2016
Who is funding the study?
Konpharma SRL (Italy)
Who is the main contact?
1. Prof G Morgia (scientific)
2. Dr GI Russo (public)
Trial website
Contact information
Type
Scientific
Primary contact
Prof Giuseppe Morgia
ORCID ID
http://orcid.org/0000-0002-7224-7577
Contact details
Via Santa Sofia 78
Catania
95100
Italy
Type
Public
Additional contact
Dr Giorgio Ivan Russo
ORCID ID
Contact details
Via Santa Sofia 78
Catania
95100
Italy
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
39/15
Study information
Scientific title
Serenoa repens, lycopene and selenium vs. phosphodiesterase type 5 inhibitor (PDE5 inhibitor) for the treatment of lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH): sprite study
Acronym
Study hypothesis
To evaluate the efficacy and tolerability of the combination therapy Serenoa repens, selenium and lycopene (Profluss®) versus a PDE5 inhibitor (Tadalafil® 5 mg) for 6 months for the treatment of LUTS/BPH.
Ethics approval
Polyclinic Hospital, University of Catania, 10/04/2015, ref: 39/2015.
Study design
Randomised non-inferiority multicentre study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS)
Intervention
1. Group A Serenoa repens 320mg, selenium and lycopene (Profluss ®) 1 tablet per day for 6 months.
2. Group B Tadalafil® 5mg 1 tablet a day for 6 months
Intervention type
Drug
Phase
Phase III/IV
Drug names
1. Serenoa repens 320mg, selenium and lycopene (Profluss ®)
2. Tadalafil® 5mg
Primary outcome measures
1. Mean change of international prostate symptom score (IPSS) and peak flow in patients treated with Profluss® or Tadalafil® 5mg. The study is designed as non-inferiority study with a 95% power and an equivalence margin of 0.5 for IPSS and of 0.8 for the peak flow.
2. IPSS quality of life (QoL) questionnaire
3. Maximum urinary flow rate (Qmax uroflowmetry)
4. International Index of Erectile Function (IIEF-5) score
Secondary outcome measures
Mean changes of post-void residual (PVR) volume in patients treated with Profluss® or Tadalafil® 5 mg at enrollment (visit 0), one month (visit 1), at 3 months (visit 2), at 6 months (visit 3).
Overall trial start date
01/05/2015
Overall trial end date
15/11/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age between 50 and 75
2. Digital rectal examination negative for prostate cancer
3. Prostate specific antigen (PSA) <4ng/ml
4. IPSS ≥12
5. PVR <100 ml
6. Peak flow between 4 and 15ml/s
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
600
Participant exclusion criteria
1. Prostate cancer, previous bladder cancer, diabetes mellitus, neurogenic disorders, severe liver
disease, history of orthostatic hypotension or syncope, symptomatic urinary tract infection.
2. Antiandrogens, antidepressants (neuroleptics, anticholinergics) therapy, recent treatment with an
α blocker (within 1 month) or phytotherapy including saw palmetto extract (within 3 months),
previous medical therapy with 5ARI, PDE-5i or surgical treatment for LUTS/BPH.
3. Patients with catheter or with an episode of acute retention of urine in the last 3 months
Recruitment start date
01/06/2015
Recruitment end date
31/12/2016
Locations
Countries of recruitment
Italy
Trial participating centre
University of Catania, G. Rodolico Hospital (Universitaria Policlinico di Catania - POG Rodolico)
Department of Urology (UOC di Urologia)
Catania
78-95123
Italy
Trial participating centre
University of Florence (Università degli Studi di Firenze)
Urology Clinic (Clinica Urologica)
Florence
50121
Italy
Trial participating centre
University of Rome Tor Vergata (Università Tor Vergata Roma)
Urology Clinic (Clinica Urologica)
Rome
00173
Italy
Trial participating centre
University of Perugia (Università degli Studi di Perugia)
Urology Clinic (Clinica Urologica)
Perugia
06100
Italy
Trial participating centre
University of Novara (Università degli Studi di Novara)
Urology Clinic (Clinica Urologica)
Novara
Italy
Trial participating centre
University of Sassari (Università degli Studi di Sassari)
Urology Clinic (Clinica Urologica)
Sassari
07100
Italy
Trial participating centre
AO Clinical Institutes of Improvement in Milan (AO Istituti Clinici di Perfezionamento di Milano)
Urology Service (Servizio Urologia)
Milan
20154
Italy
Trial participating centre
Buccheri La Ferla Hospital (Ospedale Buccheri La Ferla)
Urology Division (Divisione Urologia)
Palermo
90123
Italy
Trial participating centre
Civil Hospital Lucca (Ospedale Civile Lucca)
Urology Division (Divisione Urologia)
Lucca
Italy
Trial participating centre
Civil Hospital of Avellino (Ospedale civile di Avellino)
Urology division (Divisione Urologia)
Avellino
83100
Italy
Trial participating centre
Hospital of Ravenna (Ospedale di Ravenna)
Urology division (Divisione Urologia)
Ravenna
Italy
Trial participating centre
Hospital Dir UO Div Urologica OC Lugo
Urology Division (Divisione Urologia)
Lugo di Romagna
Italy
Trial participating centre
Urology of the New Hospital (Urologia del Nuovo Ospedale)
Urology division (Divisione Urologia)
Prato
Italy
Trial participating centre
Regina Margherita Hospital (Ospedale Nuovo Regina Margherita)
Urology Division (Divisione Urologia)
Rome
00153
Italy
Trial participating centre
Hospital SS Annunziata (Ospedale SS Annunziata)
Urology Division (Divisione Urologia)
Cuneo
Savigliano
12038
Italy
Trial participating centre
Hospital Santa Croce (Presidio Ospedaliero Santa Croce)
Urology Division (Divisione Urologia)
Fano Pesaro Urbino
61032
Italy
Trial participating centre
United Hospitals of Ancona (Ospedali Riuniti di Ancona)
Urology Division (Divisione Urologia)
Ancona
Italy
Trial participating centre
Urology Hospital Frascati (Urologia Ospedale Frascati)
Urology Division (Divisione Urologia)
Frascati
Italy
Trial participating centre
Fatebenefratelli Hospital (Ospedale Fatebenefratelli)
Urology Division (Divisione Urologia)
Rome
00186
Italy
Trial participating centre
Cardarelli Hospital (Ospedale Cardarelli)
Urology Division (Divisione Urologia)
Napoli
80131
Italy
Trial participating centre
Palermo Civic Hospital (Ospedale Civico Palermo)
Urology Division (Divisione Urologia)
Palermo
90127
Italy
Trial participating centre
ASP Catania
Urology Division (Divisione Urologia)
Acireale
Italy
Trial participating centre
Hospital Riuniti (Ospedale Riuniti)
Urology (UOC Urologia)
Reggio Calabria
Italy
Trial participating centre
Daughters of St. Camillus (Figlie di San Camillo)
Urology Division (Divisione Urologia)
Rome
Italy
Trial participating centre
ASL di Collegno e Pinerolo Hospital (ASL di Collegno e Pinerolo)
Urology Division (Divisione Urologia)
Torino
Italy
Trial participating centre
Hospital Garibaldi (Ospedale Garibaldi)
Urology (UOC Urologia)
Catania
95124
Italy
Trial participating centre
Civic Hospital (Ospedale Civico)
Urology (UOC Urologia)
Palermo
90127
Italy
Trial participating centre
Nursing Home Fabia Mater (Casa di Cura Fabia Mater)
Urology Division (Divisione Urologia)
Rome
00171
Italy
Funders
Funder type
Industry
Funder name
Konpharma SRL (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We are planning to disseminate preliminary results in the form of an abstract in December 2017, and the full results in June 2018.
Intention to publish date
01/06/2018
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary