Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression

Study Overview
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Brief Summary
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The purpose of this study is: To assess safety of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia (BPH) and risk of progression. To assess efficacy of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia and risk of progression.

Official Title
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Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Afalaza
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients 45 to 60 y.o. inclusive with a documented diagnosis of Benign prostatic hyperplasia. Lower urinary tract symptoms (LUTS) having been experienced for 3 months and longer. Total IPSS score (International Prostate Symptome Score) of 8 to 15. Prostate volume of more than 30 cm3. Maximal urinary flow rate of 10-15 mL/sec. Micturition volume of 125-350 mL. Residual volume of less than 100 mL. Serum prostate-specific antigen (PSA) level of less than 4 ng/mL. Use of and compliance with contraceptive methods during the trial and for 30 days upon completion of participation in the trial. Presence of the patient's information sheet (informed consent form) for participation in the clinical trial. Exclusion Criteria: Invasive therapies for BPH including a transurethral prostatic resection, thermotherapy, microwave therapy, transurethral needle ablation, stenting, etc. Malignant oncological disease of the urogenital system as well as malignancies of any other localization during last 5 years. Acute urinary retention (AUR) within 3 months before inclusion in the trial. Neurogenic dysfunctions and bladder ears. Urinary stone disease. Urethral stricture, bladder neck sclerosis. History of operative aids for pelvic organs. Urogenital infections in the phase of active inflammation. Systematic administration of agents exhibiting effects on bladder function and urine production. Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial, including severe concurrent cardiovascular conditions and disorders of the nervous system, renal and hepatic insufficiency. History of administration of testosterone 5-alpha-reductase inhibitors (finasteride, dutasteride). History of polyvalent allergy. Allergy/intolerance to any component of drug agents used in the therapy. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency. Administration of drugs specified as Prohibited concomitant therapy, within 3 months before enrollment. Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial. Drug and alcohol consumption (over 2 alc. units daily), mental diseases. Legal incapacity or limited legal capacity. Legal incapacitation or limited legal capacity. Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure. Participation in other clinical trials within 3 months before enrolment in this trial. Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips). A patient is a part of the center's research staff, taking a direct part in the trial, or an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children or siblings, regardless of whether full blood or adopted. The patient is employed with Scientific Production Firm Materia Medica Holding LLC, i.e. is the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Afalaza (2 tablets twice a day)<br> | Drug: Afalaza<br>* Safety and Efficacy<br>|
| Placebo Comparator: Placebo (2 tablets twice a day)<br> | Drug: Placebo<br>* Safety and Efficacy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline. | The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study. | Baseline, 1, 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline | The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study. The sum of IPSS questions 2, 4, and 7 related to irritative symptoms. The total score of irritative symptoms can therefore range from 0 to 15 points (asymptomatic to very symptomatic). | Baseline and 1, 3, 6, 12 months | 
| Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline |  | Baseline and 1, 3, 6 and 12 months | 
| Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline |  | Baseline and 1, 3, 6 and 12 months | 
| Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline | Change in the volume of the prostate gland as a percentage of the baseline according to transrectal ultrasound | Baseline and 3, 6 and 12 months | 
| Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline |  | Baseline and 3, 6 and 12 months | 
| Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline | according to transabdominal ultrasound | Baseline and 3, 6 and 12 months | 
| Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline | Quality of life (QoL) Due to Urinary Symptoms is an eight point of the IPSS scale referred to the patient's quality of life. The answers to this question range from delighted to terrible or 0 to 5. | Baseline and 3, 6 and 12 months | 
| Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline | To assess the risk of BPH progression, the following were used: 1) moderate to severe BPH symptoms (ie, IPSS total score> 7); 2) an increase in the volume of the prostate gland (> 30 cm^2); 3) increased PSA level in the blood (≥ 1.4 ng / ml); 4) a decrease in Qmax (<12 ml / s) and 5) a large volume of residual urine (> 200 ml). The total value of risk factors for progression is assessed as the sum of the risk factors that the patient had at the time of inclusion in the study (presence of risk factors = 1 point, absence = 0 points). After 3, 6 and 12 months of treatment, the dynamics of risk factors for progression was assessed: an increase in the severity of the risk factor meant +1, no change = 0, a decrease in the severity of the risk factor of -1. | Baseline and 3, 6 and 12 months | 
| Number of Episodes of Acute Urinary Retention, Surgical Intervention During the Observation Period |  | 12 months |