Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

NCT ID: NCT05558007

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-22
• Study Completion Date: 2025-01-31

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.

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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction; Prostate Cancer; Radical Prostatectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Daily oral Tadalafil 5mg + Topical Placebo

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

Group Type: ACTIVE_COMPARATOR

Tadalafil 5mg

Intervention Type: DRUG

Daily oral administration of tadalafil 5mg

Topical Placebo

Intervention Type: DRUG

Topical application of 1.5 mL of placebo

Daily oral placebo + topical BZ371A

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

Group Type: EXPERIMENTAL

BZ371A

Intervention Type: DRUG

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

Oral Placebo

Intervention Type: DRUG

Oral administration of a placebo pill

Daily oral Tadalafil 5mg + topical BZ371A

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

Group Type: ACTIVE_COMPARATOR

Tadalafil 5mg

Intervention Type: DRUG

Daily oral administration of tadalafil 5mg

BZ371A

Intervention Type: DRUG

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

Interventions

Tadalafil 5mg

Daily oral administration of tadalafil 5mg

Intervention Type: DRUG

BZ371A

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

Intervention Type: DRUG

Oral Placebo

Oral administration of a placebo pill

Intervention Type: DRUG

Topical Placebo

Topical application of 1.5 mL of placebo

Intervention Type: DRUG

Other Intervention Names

Tadalafil

Eligibility Criteria

Inclusion Criteria

1. Men between the ages of 40 and 65 years;

2. Exclusive heterosexual men, regardless of race or social class.

3. RP due to prostate cancer without metastasis;

4. RP performed less than 60 days before the screening visit;

5. Erectile function prior to normal RP, defined as IIEF questionnaire with more than 22 points in domain A;

6. Stable sexual partner (more than 2 months prior to RP), and intention to maintain the relationship during the study.

7. Continuous use of 5mg Tadalafil from the 30th up to the 60th day after RP.

Exclusion Criteria

1. Prostate cancer in TNM stage classified as T3 or T4.

2. Perineal and/or open RP;

3. Necessity of other therapy for prostate cancer than RP, including radiation therapy or hormone therapy;

4. Uncontrolled diabetes at screening visit (HbA1C > 10%);

5. Prior spinal cord injury with lower limb paralysis;

6. 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);

7. Patients with current depression, characterized by use or need for use of antidepressants.

8. 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;

9. Use of topical medications in the genital region that may interfere in the IP evaluation, as well as in its absorption or drug interaction;

10. Possession of penile prosthesis;

11. 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;

12. Current use of nitrates, such as propatilnitrate (Sustrate®), isosorbide (Monocordil®, Cincordil®, Isordil®), nitroglycerin (Nitradisc®, Nitroderm TTS®, Nitronal®, Tridil®) and isosorbitol dinitrate (Isocord®);ketoconazole; ritonavir; and rifampicin.

13. 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;

14. 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";

15. Diseases that can cause priapism, such as sickle cell anemia, multiple myeloma, or leukemia;

16. Histroy of priapism, defined as painful erection from up to 6 hours.

17. 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;

18. Known hypersensitivity to tadalafil and/or BZ371A;

19. History of symptomatic Lactose intolorence such as: the necessity of enzymatic treatment, abdominal distension or diarrhea when ingesting products or supplements with lactose;

20. Low adhsesion to 5mg Tadalafil use, characterized by the use of <80% of the pills between the 30th and 60th day post PR;.

21. Pregnant or lacting partner.

22. Partner in childbearing age which does not accept to get exposed to the treatment

23. Any disease, condition or physical finding that the Investigator considers significant and that increases the risk of the research subject's participation or may interfere with the results, including severe debilitating illness, presence of cancer other than prostate cancer, severe mental illness persistent medication abuse;

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Biozeus Biopharmaceutical S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luiz Otávio Torres, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital Urológica

Locations

Hospital Urológica

Belo Horizonte, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Camilla NR Trindade, PhD

Role: CONTACT

camilla.nunes@biozeus.com.br

+55(21)2523-9089

Facility Contacts

Luiz Otávio Torres, Dr.

Role: primary

contatoestudo2023@gmail.com

3190737299

Other Identifiers

BZ371CLI004

Identifier Type: -

Identifier Source: org_study_id