Role of Dutasteride in Treatment of Chronic Prostatitis

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Category IIIB Chronic Prostatitis; Dutasteride

Treatments: Drug: Dutasteride 0.5 mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04756206

R21/2020

Details and patient eligibility

About

this placebo controlled study aims to evaluate the efficacy of Dutasteride in the management of Chronic prostatitis type 3.

Full description

Nonbacterial prostatitis refers to a condition that affects patients who present with symptoms of prostatitis without a positive culture for urine or expressed prostate secretions (EPS). With time our understanding of prostatitis was evolved to include a different clinical phenotype with a variety of voiding presentation and symptomatology rather than just inflammation and infection. The two main clinical presentations of prostatitis include pelvic pain and LUTS.

The National Institutes of Health and the National Institute of Diabetes and Digestive and Kidney Diseases (NIH-NIDDK) proposed the first classification of prostatitis into 4 categories in 1995 that was later published in 1998. Bacterial prostatitis represented category I and III while nonbacterial prostatitis including chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) was categorized as category III that was further subdivided into class IIIa (inflammatory CPPS) and b (non-inflammatory CPPS). Category IV encompasses asymptomatic inflammatory prostatitis.

Shoskes et al, mentioned that inflammation and the upregulation of cytokine expression and release in the prostate secondary to an inflammatory process led to the presenting symptoms in such a condition. The recently introduced UPOINT phenotype categorization of CP/CPPS (Urinary, Psychosocial, Organ-specific, Infection, Neurological/Systemic, Tenderness of the skeletal muscles). This categorization shows up to 60% of men have at least prostate organ associated symptoms.

The prostate lies under the hormonal control of dihydrotestosterone (DHT); thus 5 alpha-reductase inhibitors (5ARIs) might be beneficial in the treatment of prostatitis. Dutasteride is a 5α-reductase inhibitor, and hence is a type of anti-androgen. It works by decreasing the production of (DHT) in certain parts of the body like the prostate gland. It inhibits all three forms of 5α-reductase and can decrease DHT levels in the blood by up to 98%.

5ARIs have been previously evaluated on a narrow scale in the management of prostatitis with promising results of safety and efficacy.

Enrollment: 50 patients

Sex: Male

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged between 40 and 70 years old, diagnosed with chronic prostatitis based on the presence of pelvic pain for ≥3 months of the preceding 6 months

Exclusion criteria

Patients with bacterial prostatitis

• documented site of infection along the urinary tract,
• urinary bladder tumors
• prostate cancer
• previous history of pelvic radiation or chemotherapy were excluded from our study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Dutasteride

Active Comparator group

Description:

Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo.

Treatment:

Drug: Dutasteride 0.5 mg

Placebo

Placebo Comparator group

Description:

same form and color of Dutasteride tablet was given at the same regimen to act as a placebo

Treatment:

Drug: Placebo