Clinical trial NCT05023824: Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With BPH
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostatic Hyperplasia
Prostate Hyperplasia
Prostatic Hypertrophy
Keywords: alpha-blocker
5α reductase inhibitor
withdrawal
benign prostatic hyperplasia
combination therapy
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 300
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in International Prostate Symptom Score (IPSS) score from baseline
timeFrame: 18 months
Secondary outcomes:
measure: Number of adverse events
timeFrame: 3, 6, 12, 18 months
measure: Change in International Prostate Symptom Score (IPSS) from baseline
timeFrame: 3, 6, 12 months
measure: Change in Overactive bladder symptom score (OABSS) from baseline
timeFrame: 3, 6, 12, 18 months
measure: Change in EuroQol five dimension scale (EQ-5D) score from baseline
timeFrame: 3, 6, 12, 18 months
measure: Change in Qmax from baseline
timeFrame: 3, 12, 18 months
measure: Change in prostate volume from baseline
timeFrame: 18 months
measure: Change in prostate-specific antigen (PSA) level from baseline
timeFrame: 18 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Yonsei University
name: Kyo Chul Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.