Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

Sponsor

Biozeus Biopharmaceutical S.A. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05558007

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction Following Radical Prostatectomy Erectile Dysfunction Prostate Cancer Radical Prostatectomy	Drug: Tadalafil 5mg Drug: BZ371A Drug: Oral Placebo Drug: Topical Placebo	Phase 2

Detailed Description

Prostate cancer remains one of the most prevalent cancer in men. For its treatment, recent technological advances demonstrate that the most effective treatment is the Radical Prostatectomy (RP) procedure. However, although curative for Prostate Cancer, can result in damage to the cavernosal nerves.

The cavernosal autonomic nerves travel posterolaterally to the prostate to enter the penis and regulate blood flow and hence erection. Thus, damage caused by RP will affect NO tissue release and blood flow regulation, causing erectile dysfunction.

BZ371A has the ability to restore local blood flow regulation by a new and innovative mechanism of action and, therefore, has potential to be a supportive therapy for RP patients (restoring the erectile function).

Thus, this study aims to evaluate efficacy, safety and tolerabilty of BZ371A on the recovery of erectile function of patients that were underwent Radical Prostatectomy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phase 2 Clinical Trial to Evaluate Safety and Efficacy of BZ371A In A Gel Applied in Patients That Performed Radical Prostatectomy

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Daily oral Tadalafil 5mg + Topical Placebo Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical placebo	Drug: Tadalafil 5mg Daily oral administration of tadalafil 5mg Other Names: Tadalafil Drug: Topical Placebo Topical application of 1.5 mL of placebo
Experimental: Daily oral placebo + topical BZ371A Patient that underwent Radical Prostatectomy will receive daily oral placebo and topical BZ371A	Drug: BZ371A Topical application of 1.5 mL of BZ371A in a concentration of 5mg/mL Drug: Oral Placebo Oral administration of a placebo pill
Active Comparator: Daily oral Tadalafil 5mg + topical BZ371A Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical BZ371A	Drug: Tadalafil 5mg Daily oral administration of tadalafil 5mg Other Names: Tadalafil Drug: BZ371A Topical application of 1.5 mL of BZ371A in a concentration of 5mg/mL

Arm

Intervention/Treatment

Active Comparator: Daily oral Tadalafil 5mg + Topical Placebo

Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical placebo

Drug: Tadalafil 5mg

Daily oral administration of tadalafil 5mg

Other Names:

Tadalafil

Drug: Topical Placebo

Topical application of 1.5 mL of placebo

Experimental: Daily oral placebo + topical BZ371A

Patient that underwent Radical Prostatectomy will receive daily oral placebo and topical BZ371A

Drug: BZ371A

Topical application of 1.5 mL of BZ371A in a concentration of 5mg/mL

Drug: Oral Placebo

Oral administration of a placebo pill

Active Comparator: Daily oral Tadalafil 5mg + topical BZ371A

Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical BZ371A

Drug: Tadalafil 5mg

Daily oral administration of tadalafil 5mg

Other Names:

Tadalafil

Drug: BZ371A

Topical application of 1.5 mL of BZ371A in a concentration of 5mg/mL

Outcome Measures

Primary Outcome Measures

Change in Assited Erectile Function [Day before Baseline, Baseline, 30 days, 60 days]
Measurement of the ability to to have an erection that allows sexual intercourse, under use of medication. This will be assessed by using the IIEF questionnaire, domain A (erectile function section) (IIEF-EF).
Change rate of successful vaginal intercourse [Day before Baseline, Baseline, 30 days, 60 days]
Rate of successful vaginal intercourse will be assessed through question 3 of the SEP (Sexual Encouter Profile) questionnaire.
Change in quality of sexual intercourse [30 days, 60 days]
Quality of sexual intercourse, through the EDITS questionnaire (Erectile Dysfunction Inventory of Treatment Satisfaction);
Change in penile extension [Baseline, 30 days, 60 days]
Penile extension, measured with a ruler.

Secondary Outcome Measures

Adverse effects report [30 days, 60 days and 75 days]
Adverse effects evaluation of compound use and application
Physical examination of the applied region [Day before Baseline, 30 days, 60 days and 75 days]
Number of participants with abnormal physical exam findings in the applied region
Change in SBP [Day before Baseline, Baseline, 30 days, 60 days and 75 days]
Change in Systolic Blood Pressure
Change in DBP [Day before Baseline, Baseline, 30 days, 60 days and 75 days]
Change in Diastolic Blood Pressure
Change in Heart Rate (HR) [Day before Baseline, Baseline, 30 days, 60 days and 75 days]
Change in Heart Rate
Basal chest electrocardiogram (ECG). [Day before Baseline, 30 days and 60 days]
Number of participants with abnormal ECG test results
Blood evaluation [Day before Baseline and 60 days]
Number of participants with abnormal laboratory test results

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Men between the ages of 40 and 65 years;
Exclusive heterosexual men, regardless of race or social class.
PR due to prostate cancer without metastasis;
PR performed less than 30 days before the screening visit;
Erectile function prior to normal PR, defined as IIEF questionnaire with more than 22 points in domain A;
Stable sexual partner (more than 2 months prior to PR), and intention to maintain the relationship during the study.

Exclusion Criteria:

Prostate cancer in TNM stage classified as T3 or T4.
PR of the perineal type;
Necessity of other therapy for prostate cancer than PR, including radiation therapy or hormone therapy;
Uncontrolled diabetes at screening visit (HbA1C > 10%);
Prior spinal cord injury with lower limb paralysis;
Current male hormone use, or hypogonadism, defined by total testosterone below 8 nmol/L (2300 pg/mL) or total testosterone between 8 and 11 nmol/L (2300 and 3170 pg/mL) and free testosterone < 220 pmol/L (< 64 ng/dL);
Patients with current depression, characterized by use or need for use of antidepressants.
Presence of genital lesions (such as severe penile fibrosis or Peyronie's disease) or active sexually transmitted disease (STD) (such as herpes, gonorrhea, candidiasis, HPV, and others) that impair analysis of local adverse effects on the genitalia;
Use of topical medications in the genital region that may interfere in the PSI evaluation, as well as in its absorption or drug interaction;
Possession of penile prosthesis;
History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patient with heart diseases (including history of angina and/or heart failure) and nephropathies;
Current use of nitrates, such as propatilnitrate (Sustrate®), isosorbide (Monocordil®, Cincordil®, Isordil®), nitroglycerin (Nitradisc®, Nitroderm TTS®, Nitronal®, Tridil®) and isosorbitol dinitrate (Isocord®);
Findings on ECG and/or laboratory tests that, in the Investigator's criteria, are considered significant and offer risk to the research volunteer's participation or may hinder the study analyses;
BP outside the limits considered safe: SBP below 90 mmHg or above 170 mmHg; or DBP below 50 mmHg or above 100 mmHg, except situations such as "white coat syndrome";
Diseases that can cause priapism, such as sickle cell anemia, multiple myeloma, or leukemia;16. History of priapism, defined as painful erection for more than 6 hours;
Current relevant diarrhea, defined as duration over four weeks, association with abdominal pain or dysabsortive syndrome, or presence of mucus, pus, or blood in the stool;
Known hypersensitivity to tadalafil and/or BZ371A;