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

21. august 2021 opdateret af: Kyo Chul Koo, Gangnam Severance Hospital

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

300

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Kyo Chul Koo, MD, PhD
  • Telefonnummer: 82-01099480342
  • E-mail: gckoo@yuhs.ac

Undersøgelse Kontakt Backup

  • Navn: Kwang Suk Lee, MD, MMS
  • Telefonnummer: 82-01089246674
  • E-mail: calmenow@yuhs.ac

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 135-720
        • Rekruttering
        • Gangnam Severance Hospital, Yonsei University College of Medicine
        • Kontakt:
          • Kyo Chul Koo, MD, PhD
          • Telefonnummer: 82-01099480342
          • E-mail: gckoo@yuhs.ac
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: alpha-blocker withdrawal
receives 5-ARI monotherapy
Medicin: alpha-blocker or 5-ARI withdrawal
Withdrawal of either alpha-blocker or 5-ARI
Andre navne:
  • alpha-blocker withdrawal
  • 5-ARI withdrawal
Eksperimentel: 5-ARI withdrawal
receives alpha-blocker monotherapy
Medicin: alpha-blocker or 5-ARI withdrawal
Withdrawal of either alpha-blocker or 5-ARI
Andre navne:
  • alpha-blocker withdrawal
  • 5-ARI withdrawal
Aktiv komparator: combination therapy
receives alpha-blocker and 5-ARI
Medicin: Maintenance of alpha-blocker and 5-ARI
Maintenance of alpha-blocker and 5-ARI

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in International Prostate Symptom Score (IPSS) score from baseline
Tidsramme: 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.
18 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of adverse events
Tidsramme: 3, 6, 12, 18 months
Adverse events includes; dizziness, headache, pounding heartbeat, weakness. decreased sexual desire, impotence, ejaculatory disorder, gynecomastia, depression, and anxiety.
3, 6, 12, 18 months
Change in International Prostate Symptom Score (IPSS) from baseline
Tidsramme: 3, 6, 12 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, 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.
3, 6, 12 months
Change in Overactive bladder symptom score (OABSS) from baseline
Tidsramme: 3, 6, 12, 18 months
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.
3, 6, 12, 18 months
Change in EuroQol five dimension scale (EQ-5D) score from baseline
Tidsramme: 3, 6, 12, 18 months
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.
3, 6, 12, 18 months
Change in Qmax from baseline
Tidsramme: 3, 12, 18 months
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.
3, 12, 18 months
Change in prostate volume from baseline
Tidsramme: 18 months
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.
18 months
Change in prostate-specific antigen (PSA) level from baseline
Tidsramme: 18 months
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.
18 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gangnam Severance Hospital

Efterforskere

  • Ledende efterforsker: Kyo Chul Koo, MD, PhD, Yonsei University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. december 2020

Primær færdiggørelse (Forventet)

7. december 2023

Studieafslutning (Forventet)

7. december 2023

Datoer for studieregistrering

Først indsendt

15. august 2021

Først indsendt, der opfyldte QC-kriterier

21. august 2021

Først opslået (Faktiske)

27. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3-2020-0451 (Andet bevillings-/finansieringsnummer: Handok Pharmaceutical)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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