Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With BPH

NCT05023824 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: 3-2020-0451
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Hyperplasia; Prostate Hyperplasia; Prostatic Hypertrophy

Keywords

alpha-blocker; 5α reductase inhibitor; withdrawal; benign prostatic hyperplasia; combination therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (7)

• Number of adverse events

  3, 6, 12, 18 months

• Change in International Prostate Symptom Score (IPSS) from baseline

  3, 6, 12 months

• Change in Overactive bladder symptom score (OABSS) from baseline

  3, 6, 12, 18 months

• Change in EuroQol five dimension scale (EQ-5D) score from baseline

  3, 6, 12, 18 months

• Change in Qmax from baseline

  3, 12, 18 months

Study Arms (3)

alpha-blocker withdrawal

EXPERIMENTAL

receives 5-ARI monotherapy

Drug: alpha-blocker or 5-ARI withdrawal

5-ARI withdrawal

EXPERIMENTAL

receives alpha-blocker monotherapy

Drug: alpha-blocker or 5-ARI withdrawal

combination therapy

ACTIVE COMPARATOR

receives alpha-blocker and 5-ARI

Drug: Maintenance of alpha-blocker and 5-ARI

Interventions

alpha-blocker or 5-ARI withdrawal DRUG

Withdrawal of either alpha-blocker or 5-ARI

Also known as: alpha-blocker withdrawal, 5-ARI withdrawal

5-ARI withdrawal; alpha-blocker withdrawal

Maintenance of alpha-blocker and 5-ARI DRUG

Maintenance of alpha-blocker and 5-ARI

combination therapy

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, 135-720, South Korea

RECRUITING

Related Publications (2)

• 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.

  PMID: 14499682 RESULT

• Nickel 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.

  PMID: 18542722 RESULT

Related Links

• Finasteride monotherapy maintains stable lower urinary tract symptoms in men with benign prostatic hyperplasia following cessation of alpha blockers
• Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5alpha-reductase inhibitor dutasteride

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Adrenergic alpha-Antagonists

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Kyo Chul Koo, MD, PhD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyo Chul Koo, MD, PhD

CONTACT

82-01099480342; gckoo@yuhs.ac

Kwang Suk Lee, MD, MMS

CONTACT

82-01089246674; calmenow@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 15, 2021
• First Posted: August 27, 2021
• Study Start: December 8, 2020
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)