Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction, Prostate Cancer, Radical Prostatectomy
Conditions
Keywords
Erectile Dysfunction, Radical Prostatectomy, Prostate Cancer
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.
Interventions
DRUGTadalafil 5mg
Daily oral administration of tadalafil 5mg
DRUGBZ371A
Topical application of 1.5 mL of BZ371A in a concentration of 5mg/mL
DRUGOral Placebo
Oral administration of a placebo pill
DRUGTopical Placebo
Topical application of 1.5 mL of placebo
Sponsors
Biozeus Biopharmaceutical S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Assisted Erectile Function | From up to 30 days 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Penile Blood flow increase | From up to 30 days before Baseline, Baseline, 30 days, 60 days | Increased blood flow, assessed by peak systolic velocity (PSV), end-diastolic velocity (EDV) and resistivity index (RI) assessed by Doppler examination; |
| Adverse effects report | Baseline 30 days, 60 days and 75 days | Adverse effects evaluation of compound use and application |
| Physical examination of the applied region | From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days | Number of participants with abnormal physical exam findings in the applied region |
| Change in successful vaginal intercourse rate | From up to 30 days 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 DBP | From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days | Change in Diastolic Blood Pressure |
| Change in Heart Rate (HR) | From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days | Change in Heart Rate |
| Basal chest electrocardiogram (ECG). | From up to 30 days before Baseline, 30 days and 60 days | Number of participants with abnormal ECG test results |
| Blood evaluation | From up to 30 days before Baseline, and 60 days | Number of participants with abnormal laboratory test results |
| Urine evaluation | From up to 30 days before Baseline, and 60 days | Number of participants with abnormal laboratory test results |
| Change in SBP | From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days | Change in Systolic Blood Pressure |
Countries
Brazil
Contacts
Primary ContactCamilla NR Trindade, PhD
Outcome results
None listed