Benign Prostatic HyperplasiaPROSPERITYNCT04831476

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)

An observational study of Benign Prostatic Hyperplasia, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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®) Read more about this study

Who is it for?: Ages 18 to 85 years, men only
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: Patients with Benign Prostate Hyperplasia
How many people: 1,296 participants
Where: 1 siteGreece
Study dates: 1 Sep 2021to 31 Oct 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
Men only
Adult, Older adult

Study population: Adult males who based on physician's recommedations will receive DINAPLEX®- Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride (equivalent to 0.367 mg tamsulosin) Tamsulosin hydrochloride Tamsulosin binds selectively and competitively to postsynaptic α1A adrenergic receptors and to a lesser extent to α1D adrenergic receptors. It relaxes the smooth muscles of the prostate and urethra. By relaxing the smooth muscle fibers of the bladder sphincter, it relieves obstructive effects and increases urine flow. It has little antihypertensive effect. Doutasteride Dutasteride lowers circulating dihydrotestosterone (DHT) levels by inhibiting the 5a-reductase isoenzymes type I and II, which are responsible for converting testosterone to DHT. The effect of dutasteride on DHT levels is dose-dependent and is observed within 1-2 weeks (85% and 90% reduction respectively).

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Greece1 site

Laikon Hospital of Athens
Athens

Other trials in Greece

About this study

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. PROSPERITY Group of Studies (I&II).

Read the 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
Being tested: Patients with Benign Prostate Hyperplasia
Keywords: Benign Prostate Hyperplasia, IPSS (International Prostate Symptom Score), LUTS (Lower Urinary Tract Symptoms)
Medical subject headings: Prostatic Hyperplasia, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patients with Benign Prostate HyperplasiaOther
patients with benign prostatic hyperplasia under fixed dose combΙnation treatment with dutasteride and tamsulosin

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of disease control (BPH), PROSPERITY I Evaluation of quality of life. PROSPERITY II
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
Measured: 3-6 months

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202131 Oct 2022

First posted5 Apr 2021
Study start1 Sep 2021
Primary completion31 Oct 2022
Study completion31 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 1,296 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04831476
Sponsor's protocol ID: 2020-DTM-EL-126/133
Acronym: PROSPERITY
Status last verified: Feb 2023
First submitted: 2 Apr 2021
Last updated: 18 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
Helga Fritch, Wolfgang Kühnel. Εγχειρίδιο Περιγραφικής Ανατομικής. s.l. : Π.Χ. Πασχαλίδης, 2009.
Presti JC Jr. (2000) Neoplasms of the prostate gland, in Smith's General Urology, 15th Edition, Tanagho EA and McAninch JW, Editors. Lange Medical Books: New York, USA. p. 399-421.
Shibata K, Hirasawa A, Moriyama N, Kawabe K, Ogawa S, Tsujimoto G. Alpha 1a-adrenoceptor polymorphism: pharmacological characterization and association with benign prostatic hypertrophy. Br J Pharmacol. 1996 Jul;118(6):1403-8. doi: 10.1111/j.1476-5381.1996.tb15552.x.
PubMed 8832064
Ekman P. The prostate as an endocrine organ: androgens and estrogens. Prostate Suppl. 2000;10:14-8. No abstract available.
PubMed 11056488
Verhamme KM, Dieleman JP, Bleumink GS, van der Lei J, Sturkenboom MC, Artibani W, Begaud B, Berges R, Borkowski A, Chappel CR, Costello A, Dobronski P, Farmer RD, Jimenez Cruz F, Jonas U, MacRae K, Pientka L, Rutten FF, van Schayck CP, Speakman MJ, Sturkenboom MC, Tiellac P, Tubaro A, Vallencien G, Vela Navarrete R; Triumph Pan European Expert Panel. Incidence and prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia in primary care--the Triumph project. Eur Urol. 2002 Oct;42(4):323-8. doi: 10.1016/s0302-2838(02)00354-8.
PubMed 12361895
Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status. J Urol. 1999 Oct;162(4):1301-6.
PubMed 10492184
Marberger MJ, Andersen JT, Nickel JC, Malice MP, Gabriel M, Pappas F, Meehan A, Stoner E, Waldstreicher J. Prostate volume and serum prostate-specific antigen as predictors of acute urinary retention. Combined experience from three large multinational placebo-controlled trials. Eur Urol. 2000 Nov;38(5):563-8. doi: 10.1159/000020356.
PubMed 11096237
Clifford GM, Logie J, Farmer RD. How do symptoms indicative of BPH progress in real life practice? The UK experience. Eur Urol. 2000;38 Suppl 1:48-53. doi: 10.1159/000052401.
PubMed 11111208
Lowe FC. Goals for benign prostatic hyperplasia therapy. Urology. 2002 Feb;59(2 Suppl 1):1-2. doi: 10.1016/s0090-4295(01)01554-0. No abstract available.
PubMed 11832306
Sanda MG, Beaty TH, Stutzman RE, Childs B, Walsh PC. Genetic susceptibility of benign prostatic hyperplasia. J Urol. 1994 Jul;152(1):115-9. doi: 10.1016/s0022-5347(17)32831-8.
PubMed 7515446
Sidney S, Quesenberry CP Jr, Sadler MC, Guess HA, Lydick EG, Cattolica EV. Incidence of surgically treated benign prostatic hypertrophy and of prostate cancer among blacks and whites in a prepaid health care plan. Am J Epidemiol. 1991 Oct 15;134(8):825-9. doi: 10.1093/oxfordjournals.aje.a116157.
PubMed 1719806
Choi J, Ikeguchi EF, Lee SW, Choi HY, Te AE, Kaplan SA. Is the higher prevalence of benign prostatic hyperplasia related to lower urinary tract symptoms in Korean men due to a high transition zone index? Eur Urol. 2002 Jul;42(1):7-11. doi: 10.1016/s0302-2838(02)00222-1.
PubMed 12121722
Geller J, Sionit L, Partido C, Li L, Tan X, Youngkin T, Nachtsheim D, Hoffman RM. Genistein inhibits the growth of human-patient BPH and prostate cancer in histoculture. Prostate. 1998 Feb 1;34(2):75-9. doi: 10.1002/(sici)1097-0045(19980201)34:23.0.co;2-i.
PubMed 9465938
Chyou PH, Nomura AM, Stemmermann GN, Hankin JH. A prospective study of alcohol, diet, and other lifestyle factors in relation to obstructive uropathy. Prostate. 1993;22(3):253-64. doi: 10.1002/pros.2990220308.
PubMed 7683816

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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. PROSPERITY Group of Studies (I&II).
ClinicalTrials.gov ID: NCT04831476
Acronym / sponsor ID: PROSPERITY / 2020-DTM-EL-126/133
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostate Hyperplasia, IPSS (International Prostate Symptom Score), LUTS (Lower Urinary Tract Symptoms)
Study type: Observational
Recruitment status: Completed
Enrolment: 1,296 participants (actual)
Lead sponsor: Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
Study start: 1 Sep 2021 (actual)
Primary completion: 31 Oct 2022 (actual)
Study completion: 31 Oct 2022 (actual)
First posted: 5 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 to 85 years
Sex: Male only
Age groups: Adult, Older adult
Study population: Adult males who based on physician's recommedations will receive DINAPLEX®- Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride (equivalent to 0.367 mg tamsulosin) Tamsulosin hydrochloride Tamsulosin binds selectively and competitively to postsynaptic α1A adrenergic receptors and to a lesser extent to α1D adrenergic receptors. It relaxes the smooth muscles of the prostate and urethra. By relaxing the smooth muscle fibers of the bladder sphincter, it relieves obstructive effects and increases urine flow. It has little antihypertensive effect. Doutasteride Dutasteride lowers circulating dihydrotestosterone (DHT) levels by inhibiting the 5a-reductase isoenzymes type I and II, which are responsible for converting testosterone to DHT. The effect of dutasteride on DHT levels is dose-dependent and is observed within 1-2 weeks (85% and 90% reduction respectively).

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patients with Benign Prostate Hyperplasiapatients with benign prostatic hyperplasia under fixed dose combΙnation treatment with dutasteride and tamsulosin	Other	–

Primary outcome

Evaluation of disease control (BPH), PROSPERITY I Evaluation of quality of life. PROSPERITY II
Time frame: 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

3 secondary outcomes

Evaluation of disease control (BPH), PROSPERITY II.
Time frame: 3-6 months
U/S measurement. PROSPERITY I&II
Time frame: 3-6 months
Number of AEs (PROSPERITY I&II)
Time frame: 3-6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
BackgroundWorld 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.
Results publicationHelga Fritch, Wolfgang Kühnel. Εγχειρίδιο Περιγραφικής Ανατομικής. s.l. : Π.Χ. Πασχαλίδης, 2009.
Results publicationPresti JC Jr. (2000) Neoplasms of the prostate gland, in Smith's General Urology, 15th Edition, Tanagho EA and McAninch JW, Editors. Lange Medical Books: New York, USA. p. 399-421.
Results publication: PubMed 8832064Shibata K, Hirasawa A, Moriyama N, Kawabe K, Ogawa S, Tsujimoto G. Alpha 1a-adrenoceptor polymorphism: pharmacological characterization and association with benign prostatic hypertrophy. Br J Pharmacol. 1996 Jul;118(6):1403-8. doi: 10.1111/j.1476-5381.1996.tb15552.x.
Results publication: PubMed 11056488Ekman P. The prostate as an endocrine organ: androgens and estrogens. Prostate Suppl. 2000;10:14-8. No abstract available.
Results publication: PubMed 12361895Verhamme KM, Dieleman JP, Bleumink GS, van der Lei J, Sturkenboom MC, Artibani W, Begaud B, Berges R, Borkowski A, Chappel CR, Costello A, Dobronski P, Farmer RD, Jimenez Cruz F, Jonas U, MacRae K, Pientka L, Rutten FF, van Schayck CP, Speakman MJ, Sturkenboom MC, Tiellac P, Tubaro A, Vallencien G, Vela Navarrete R; Triumph Pan European Expert Panel. Incidence and prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia in primary care--the Triumph project. Eur Urol. 2002 Oct;42(4):323-8. doi: 10.1016/s0302-2838(02)00354-8.
Results publication: PubMed 10492184Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status. J Urol. 1999 Oct;162(4):1301-6.
Results publication: PubMed 11096237Marberger MJ, Andersen JT, Nickel JC, Malice MP, Gabriel M, Pappas F, Meehan A, Stoner E, Waldstreicher J. Prostate volume and serum prostate-specific antigen as predictors of acute urinary retention. Combined experience from three large multinational placebo-controlled trials. Eur Urol. 2000 Nov;38(5):563-8. doi: 10.1159/000020356.
Results publication: PubMed 11111208Clifford GM, Logie J, Farmer RD. How do symptoms indicative of BPH progress in real life practice? The UK experience. Eur Urol. 2000;38 Suppl 1:48-53. doi: 10.1159/000052401.
Results publication: PubMed 11832306Lowe FC. Goals for benign prostatic hyperplasia therapy. Urology. 2002 Feb;59(2 Suppl 1):1-2. doi: 10.1016/s0090-4295(01)01554-0. No abstract available.
Results publication: PubMed 7515446Sanda MG, Beaty TH, Stutzman RE, Childs B, Walsh PC. Genetic susceptibility of benign prostatic hyperplasia. J Urol. 1994 Jul;152(1):115-9. doi: 10.1016/s0022-5347(17)32831-8.
Results publication: PubMed 1719806Sidney S, Quesenberry CP Jr, Sadler MC, Guess HA, Lydick EG, Cattolica EV. Incidence of surgically treated benign prostatic hypertrophy and of prostate cancer among blacks and whites in a prepaid health care plan. Am J Epidemiol. 1991 Oct 15;134(8):825-9. doi: 10.1093/oxfordjournals.aje.a116157.
Individual participant dataSharing planned: No

Related trials for Benign Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Benign Prostatic Hyperplasia, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of disease control (BPH), PROSPERITY I Evaluation of quality of life. PROSPERITY II (time frame: 3-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04831476, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.