Prostatic HyperplasiaPhase 3NCT05023824
Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With BPH
A Phase 3 study testing alpha-blocker or 5-ARI withdrawal and Maintenance of alpha-blocker and 5-ARI in people with Prostatic Hyperplasia and Prostate Hyperplasia, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
The investigators compare the efficacy of alpha-blocker and 5-ARI withdrawal to continued combination therapy on the maintenance of LUTS and improvement of quality of life outcomes in men with benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia, Prostate Hyperplasia, Prostatic Hypertrophy
- What is being tested?
- alpha-blocker or 5-ARI withdrawal and Maintenance of alpha-blocker and 5-ARI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Dec 2020to 7 Dec 2023
- Phase
- Phase 3
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged ≥50 or <80 years AND
- On combination therapy (alpha-blocker and 5-ARI) ≥12 months AND
- IPSS score (≤30% decrease from baseline) AND
- Prostate volume (≤35% decrease from baseline)
Who cannot join
- Suspected prostate cancer (PSA density >0.15 ng/ml/cc) requiring specific management
- On-going prostatitis or urinary retention
- Acontractile detrusor
- Neurogenic lower urinary tract dysfunction
- Urethral stenosis
- Patient unable or unwilling to provide written informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, 135-720
Kyo Chul Koo, MD, PhD, 82-01099480342, gckoo@yuhs.ac
Kwang Suk Lee, MD, MMS, 82-01089246674, calmenow@yuhs.ac
About this study
Official title: A Prospective, Randomized, Open Label, Parallel Trial Comparing the Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With Benign Prostatic Hyperplasia
The investigators compare the efficacy of alpha-blocker and 5-ARI withdrawal to continued combination therapy on the maintenance of LUTS and improvement of quality of life outcomes in men with benign prostatic hyperplasia.
Read the detailed description
Benign Prostatic Hyperplasia (BPH) is the primary cause of lower urinary tract symptoms (LUTS). Combination therapy with an alpha-blocker and 5α reductase inhibitors (5-ARI) is the first-line treatment of BPH-related LUTS for the reduction of the size of the prostate and LUTS improvement. Combination therapy is tolerated well by most men; however, the incidence of adverse events is higher than with either therapy alone. In patients with improved LUTS following combination therapy, the aim of this study is based on the hypothesis that the withdrawal of either therapy will not increase the risk of LUTS aggravation while improving the quality of life.
The investigators plan a prospective, randomized, open-label, parallel trial, comparing alpha-blocker withdrawal and 5-ARI withdrawal to continued combination therapy. Treatments will be allocated in a 1:1:1 ratio, based on IPSS score (≤30% decrease from baseline) and prostate volume (≤35% decrease from baseline).
- Being tested
- alpha-blocker or 5-ARI withdrawal, Maintenance of alpha-blocker and 5-ARI
- Keywords
- alpha-blocker, 5α reductase inhibitor, withdrawal, benign prostatic hyperplasia, combination therapy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha-blocker or 5-ARI withdrawalDrug
Also called alpha-blocker withdrawal, 5-ARI withdrawal
Withdrawal of either alpha-blocker or 5-ARI
Maintenance of alpha-blocker and 5-ARIDrug
Maintenance of alpha-blocker and 5-ARI
| Study group | Role | What they receive |
|---|---|---|
| alpha-blocker withdrawal | Experimental | receives 5-ARI monotherapy Receives: Drug: alpha-blocker or 5-ARI withdrawal |
| 5-ARI withdrawal | Experimental | receives alpha-blocker monotherapy Receives: Drug: alpha-blocker or 5-ARI withdrawal |
| combination therapy | Active comparator | receives alpha-blocker and 5-ARI Receives: Drug: Maintenance of alpha-blocker and 5-ARI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score (IPSS) score from baseline
IPSS is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS is self-administered at screening and each time-point of month 3, 6, 12, and 18. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). Month 18 is the primary timepoint and earlier timepoints are considered secondary. Change from baseline defined as difference between post-baseline value and baseline value.
Measured: 18 months
Secondary outcomes (7)
Number of adverse events
Adverse events includes; dizziness, headache, pounding heartbeat, weakness. decreased sexual desire, impotence, ejaculatory disorder, gynecomastia, depression, and anxiety.
Measured: 3, 6, 12, 18 months
Change in International Prostate Symptom Score (IPSS) from baseline
IPSS is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS is self-administered at screening and each time-point of month 3, 6, and 12. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). Change from baseline defined as difference between post-baseline value and baseline value.
Measured: 3, 6, 12 months
Change in Overactive bladder symptom score (OABSS) from baseline
The OABSS is a symptom assessment questionnaire designed to quantify OAB symptoms into a single score. The questionnaire consists of 4 questions on OAB symptoms with maximum scores ranging from 2 to 5: daytime frequency (2 points), night-time frequency (3 points), urgency (5 points), and UUI (5 points). OABSS is self-administered at screening and each time-point of month 3, 6, 12 and 18. Change from baseline defined as difference between post-baseline value and baseline value.
Measured: 3, 6, 12, 18 months
Change in EuroQol five dimension scale (EQ-5D) score from baseline
The EuroQol five dimension descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ-5D is self-administered at screening and each time-point of month 3, 6, 12 and 18. Change from baseline defined as difference between post-baseline value and baseline value.
Measured: 3, 6, 12, 18 months
Change in Qmax from baseline
The measurement of maximum urinary flow rate (Qmax) is widely used in the assessment of men complaining of lower urinary tract symptoms. Qmax is performed at screening and each time-point of month 3, 12, and 18. Change from baseline defined as difference between post-baseline value and baseline value.
Measured: 3, 12, 18 months
Change in prostate volume from baseline
The measurement of prostate volume is performed at screening and at month 18. Change from baseline defined as difference between post-baseline value and baseline value.
Measured: 18 months
Change in prostate-specific antigen (PSA) level from baseline
The measurement of prostate-specific antigen (PSA) level is performed at screening and at month 18. Change from baseline defined as difference between post-baseline value and baseline value.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start8 Dec 2020
- Primary completion7 Dec 2023 (estimated)
- Study completion7 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyo Chul Koo, Gangnam Severance Hospital
- Investigators
- Kyo Chul Koo, MD, PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023824
- Sponsor's protocol ID
- 3-2020-0451
- Other IDs
- 3-2020-0451
- Status last verified
- Aug 2021
- First submitted
- 15 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barkin J, Guimaraes M, Jacobi G, Pushkar D, Taylor S, van Vierssen Trip OB. Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5alpha-reductase inhibitor dutasteride. Eur Urol. 2003 Oct;44(4):461-6. doi: 10.1016/s0302-2838(03)00367-1.
PubMed 14499682Nickel JC, Barkin J, Koch C, Dupont C, Elhilali M. Finasteride monotherapy maintains stable lower urinary tract symptoms in men with benign prostatic hyperplasia following cessation of alpha blockers. Can Urol Assoc J. 2008 Feb;2(1):16-21. doi: 10.5489/cuaj.520.
PubMed 18542722
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open Label, Parallel Trial Comparing the Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT05023824
- Acronym / sponsor ID
- 3-2020-0451
- Keywords
- alpha-blocker, 5α reductase inhibitor, withdrawal, benign prostatic hyperplasia, combination therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 7 Dec 2023 (estimated)
- Study completion
- 7 Dec 2023 (estimated)
- First posted
- 27 Aug 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.
The investigators compare the efficacy of alpha-blocker and 5-ARI withdrawal to continued combination therapy on the maintenance of LUTS and improvement of quality of life outcomes in men with benign prostatic hyperplasia.
Detailed description
Benign Prostatic Hyperplasia (BPH) is the primary cause of lower urinary tract symptoms (LUTS). Combination therapy with an alpha-blocker and 5α reductase inhibitors (5-ARI) is the first-line treatment of BPH-related LUTS for the reduction of the size of the prostate and LUTS improvement. Combination therapy is tolerated well by most men; however, the incidence of adverse events is higher than with either therapy alone. In patients with improved LUTS following combination therapy, the aim of this study is based on the hypothesis that the withdrawal of either therapy will not increase the risk of LUTS aggravation while improving the quality of life.
The investigators plan a prospective, randomized, open-label, parallel trial, comparing alpha-blocker withdrawal and 5-ARI withdrawal to continued combination therapy. Treatments will be allocated in a 1:1:1 ratio, based on IPSS score (≤30% decrease from baseline) and prostate volume (≤35% decrease from baseline).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| alpha-blocker withdrawal | Experimental | Drug: alpha-blocker or 5-ARI withdrawalreceives 5-ARI monotherapy |
| 5-ARI withdrawal | Experimental | Drug: alpha-blocker or 5-ARI withdrawalreceives alpha-blocker monotherapy |
| combination therapy | Active comparator | Drug: Maintenance of alpha-blocker and 5-ARIreceives alpha-blocker and 5-ARI |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men aged ≥50 or <80 years AND
- On combination therapy (alpha-blocker and 5-ARI) ≥12 months AND
- IPSS score (≤30% decrease from baseline) AND
- Prostate volume (≤35% decrease from baseline)
Key exclusion criteria (6 listed)
- Suspected prostate cancer (PSA density >0.15 ng/ml/cc) requiring specific management
- On-going prostatitis or urinary retention
- Acontractile detrusor
- Neurogenic lower urinary tract dysfunction
- Urethral stenosis
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 |
|---|---|---|
| alpha-blocker or 5-ARI withdrawalAlso: alpha-blocker withdrawal, 5-ARI withdrawalWithdrawal of either alpha-blocker or 5-ARI | Drug | 5-ARI withdrawal, alpha-blocker withdrawal |
| Maintenance of alpha-blocker and 5-ARIMaintenance of alpha-blocker and 5-ARI | Drug | combination therapy |
Primary outcome
Change in International Prostate Symptom Score (IPSS) score from baseline
Time frame: 18 months
IPSS is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS is self-administered at screening and each time-point of month 3, 6, 12, and 18. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). Month 18 is the primary timepoint and earlier timepoints are considered secondary. Change from baseline defined as difference between post-baseline value and baseline value.
7 secondary outcomes
Number of adverse events
Time frame: 3, 6, 12, 18 months
Change in International Prostate Symptom Score (IPSS) from baseline
Time frame: 3, 6, 12 months
Change in Overactive bladder symptom score (OABSS) from baseline
Time frame: 3, 6, 12, 18 months
Change in EuroQol five dimension scale (EQ-5D) score from baseline
Time frame: 3, 6, 12, 18 months
Change in Qmax from baseline
Time frame: 3, 12, 18 months
Change in prostate volume from baseline
Time frame: 18 months
Change in prostate-specific antigen (PSA) level from baseline
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Results publication: PubMed 14499682Barkin J, Guimaraes M, Jacobi G, Pushkar D, Taylor S, van Vierssen Trip OB. Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5alpha-reductase inhibitor dutasteride. Eur Urol. 2003 Oct;44(4):461-6. doi: 10.1016/s0302-2838(03)00367-1.
- Results publication: PubMed 18542722Nickel JC, Barkin J, Koch C, Dupont C, Elhilali M. Finasteride monotherapy maintains stable lower urinary tract symptoms in men with benign prostatic hyperplasia following cessation of alpha blockers. Can Urol Assoc J. 2008 Feb;2(1):16-21. doi: 10.5489/cuaj.520.
- Finasteride monotherapy maintains stable lower urinary tract symptoms in men with benign prostatic hyperplasia following cessation of alpha blockersLink provided by the sponsor.
- Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5alpha-reductase inhibitor dutasterideLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kyo Chul Koo, MD, PhD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alpha-blocker or 5-ARI withdrawal and Maintenance of alpha-blocker and 5-ARI in people with Prostatic Hyperplasia and Prostate Hyperplasia, run by Gangnam Severance Hospital at 1 site in South Korea.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Aug 2021. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyo Chul Koo, MD, PhD (82-01099480342, gckoo@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) score from baseline (time frame: 18 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 NCT05023824, which also lists 2 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 27 Aug 2021.