Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

A Multi-center, Randomized, Double-blinded, Double-dummy, Parallel Group, 48-week, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

This is a multi-center, randomized, double-blinded, double-dummy, parallel group, 48-week study to evaluated the efficacy and safety of DKF-313 (dutasteride and tadalafil) in patients with benign prostatic hyperplasia.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: DKF-313; Drug: Dutasteride placebo; Drug: Tadalafil placebo; Drug: Dutasteride; Drug: DKF-313 placebo; Drug: Tadalafil

Detailed Description

This study is conducted to access whether DKF-313 once daily for 48 weeks is superior to dutasteride 0.5 mg once daily and tadalafil 5 mg once daily each in improving BPH-LUTS as measured by changes in IPSS total scores.

• Study Type: Interventional
• Enrollment (Actual): 667
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Choung-Soo Kim, M.D.; Phone Number: +82230103734; Email: cskim@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male aged 45 to 80 years
• BPH diagnosis
• Voluntarily signed the informed consent form
• Willing to participate in the study
• Total IPSS 13 or greater at baseline
• Prostate volume 30 cc or greater by TRUS at baseline
• Qmax 4 to 15 mL/s and minimum voided volume 125 mL or greater at baseline

Exclusion Criteria:

• Serum PSA 4 ng/mL or greater with a positive biopsy result
• Malignant urogenital tumors including prostate cancer, bladder cancer, etc.
• Previous prostatic surgery including TURP, balloon dilatation, thermotherapy and stent replacement or other invasive procedures to treat prostate
• Prostate biopsy within 4 weeks of screening
• Use of alpha-blockers, alpha-agonists, phosphodiesterase type 5 (PDE5) inhibitors, antidiuretics, anticholinergics, cholinergics, antispasmodics, nitrates or herbal preparations affecting prostate within 4 weeks of screening, or 5-alpha reductase inhibitors (5-ARIs) within 24 weeks of screening
• Acute urinary retention within 12 weeks of screening
• Any causes other than BPH resulting in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, acute or chronic urinary tract infections)
• Bladder postvoid residual 200 mL or greater
• Anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or conditions that might predispose to priapism (such as sickle cell anemia, multiple myeloma, or leukemia)
• Cardiovascular diseases such as myocardial infarction within 12 weeks of screening, unstable angina or angina during sexual intercourse, heart failure (NYHA Class 2 or higher) within 24 weeks of screening, uncontrolled arrhythmias, hypotension (<90/50 mmHg) or uncontrolled hypertension (>170/100 mmHg), or stroke within 24 weeks of screening
• Left ventricular outflow obstruction (e.g. aortic stenosis and idiopathic hypertrophic subaortic stenosis)
• Inherited disorders including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Inherited retinal degeneration including retinitis pigmentosa
• Vision loss in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION)
• Hypersensitivity to ingredients of investigational products
• Alcohol or drug abuse or treating psychiatric disorders
• Severe hepatic impairment (ALT or AST > 3xULN)
• Renal impairment with severe heart failure (serum creatinine > 2xULN)
• Uncontrolled diabetes (HbA1c 9% or greater)
• Other investigational products or procedures within 12 weeks of screening
• Plans to have a child or unwilling to comply with using medically accepted contraception methods (such as surgical sterilization and condom) during the treatment period
• Not eligible due to other reasons at the investigator's discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DKF-313; Dutasteride 0.5mg + Tadalafil 5mg	Drug: DKF-313; Combination of dutasteride 0.5 mg and tadalafil 5 mg once daily for 48 weeks; Drug: Dutasteride placebo; Once daily for 48 weeks; Drug: Tadalafil placebo; Once daily for 48 weeks
Active Comparator: Dutasteride; Dutasteride 0.5mg	Drug: Tadalafil placebo; Once daily for 48 weeks; Drug: Dutasteride; Dutasteride 0.5 mg once daily for 48 weeks; Other Names: Avodart; Drug: DKF-313 placebo; Once daily for 48 weeks
Active Comparator: Tadalafil; Tadalafil 5mg	Drug: Dutasteride placebo; Once daily for 48 weeks; Drug: DKF-313 placebo; Once daily for 48 weeks; Drug: Tadalafil; Tadalafil 5 mg once daily for 48 weeks; Other Names: Cialis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Total International Prostate Symptom Score (IPSS) from baseline to Week 48	Weeks 0 and 48

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Total International Prostate Symptom Score (IPSS) from baseline to Weeks 4, 12, 24 and 36	Weeks 0, 4, 12, 24 and 36
Change in Total International Prostate Symptom Score (IPSS) voiding (obstructive) subscores from baseline to Weeks 4, 12, 24, 36 and 48	Weeks 0, 4, 12, 24, 36 and 48
Change in Total International Prostate Symptom Score (IPSS) storage (irritative) subscores from baseline to Weeks 4, 12, 24, 36 and 48	Weeks 0, 4, 12, 24, 36 and 48
Change in Total International Prostate Symptom Score (IPSS) Quality of Life (QoL) index from baseline to Weeks 4, 12, 24, 36 and 48	Weeks 0, 4, 12, 24, 36 and 48
Change in Qmax from baseline to Weeks 24 and 48	Weeks 0, 24 and 48
Change in post void residual (PVR) volume from baseline to Weeks 24 and 48	Weeks 0, 24 and 48
Change in prostate volume (PV) from baseline to Week 48	Weeks 0 and 48
Change in prostate specific antigen (PSA) from baseline to Weeks 24 and 48	Weeks 0, 24 and 48

Other Outcome Measures

Outcome Measure	Time Frame
Change in International Index of Erectile Function (IIEF) - Erectile Function (EF) domain scores from baseline to Weeks 4, 12, 24, 36 and 48	Weeks 0, 4, 12, 24, 36 and 48
Change in Sexual Encounter Profile (SEP) Q2 and Q3 from baseline to Weeks 4, 12, 24, 36 and 48	Weeks 0, 4, 12, 24, 36 and 48

Collaborators and Investigators

• Sponsor: Dongkook Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Choung-Soo Kim, M.D.,Ph.D, Ewha Womans University Mokdong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): June 12, 2023

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; 5-alpha Reductase Inhibitors; Tadalafil; Dutasteride
• Other Study ID Numbers: DKF-313-P3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No