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

Yonsei University Health System (YUHS)

Status and phase: Unknown; Phase 3

Conditions: Prostate Hyperplasia; Prostatic Hypertrophy; Prostatic Hyperplasia

Treatments: Drug: alpha-blocker or 5-ARI withdrawal; Drug: Maintenance of alpha-blocker and 5-ARI

Study type: Interventional

Funder types: Other

Identifiers

NCT05023824

3-2020-0451 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

alpha-blocker withdrawal

Experimental group

Description:

receives 5-ARI monotherapy

Treatment:

Drug: alpha-blocker or 5-ARI withdrawal

5-ARI withdrawal

Experimental group

Description:

receives alpha-blocker monotherapy

Treatment:

Drug: alpha-blocker or 5-ARI withdrawal

combination therapy

Active Comparator group

Description:

receives alpha-blocker and 5-ARI

Treatment:

Drug: Maintenance of alpha-blocker and 5-ARI