Role of Dutasteride in Treatment of Chronic Prostatitis

• ClinicalTrials.gov Identifier: NCT04756206
• Recruitment Status: Completed
• First Posted: February 16, 2021
• Last Update Posted: February 16, 2021
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Ahmed Maher Gamil Ahmed Higazy, Ain Shams University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Dutasteride; Category IIIB Chronic Prostatitis	Drug: Dutasteride 0.5 mg; Drug: Placebo	Phase 2; Phase 3

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Role of Dutasteride in Treatment of Category IIIB Chronic Prostatitis (A Placebo-Controlled Study)
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: January 1, 2020
• Actual Study Completion Date: September 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Dutasteride; Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo.	Drug: Dutasteride 0.5 mg; patients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention.
Placebo Comparator: Placebo; same form and color of Dutasteride tablet was given at the same regimen to act as a placebo	Drug: Placebo; patients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention.

Outcome Measures

Primary Outcome Measures :

1. NIH chronic prostatitis symptom index in study population [ Time Frame: assessment was made before treatment ]
   scoring system aims to evaluate chronic prostatitis and severity of symptoms
2. NIH chronic prostatitis symptom index in study population [ Time Frame: assessment was made at 3 months after intervention ]
   scoring system aims to evaluate chronic prostatitis and severity of symptoms

Secondary Outcome Measures :

1. change in libido in study population [ Time Frame: 3 months after medication ]
   according to sexual desire inventory -2
2. Gastritis in study population [ Time Frame: 3 months after medication ]
   side effect of medication (if present or not)
3. Dizziness in study population [ Time Frame: 3 months after medication ]
   side effect of medication (if present or not)

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Chronic prostatitis is a disease that affects men only.
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Egypt

Urology department - ain shams university

Cairo, Egypt, 11361

Sponsors and Collaborators

Ain Shams University

More Information

• Responsible Party: Ahmed Maher Gamil Ahmed Higazy, Assistant lecturer, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04756206
• Other Study ID Numbers: R21/2020
• First Posted: February 16, 2021
• Last Update Posted: February 16, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Prostatitis; Chronic Disease; Prostatic Diseases; Disease Attributes; Pathologic Processes; Dutasteride; 5-alpha Reductase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs