Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT05081232
Eligibility Criteria:
Inclusion Criteria:
1. Male subjects with at least age of 30 to 65
2. Primary diagnosis of prostate cancer selected for surgical intervention (Radical Prostatectomy)
3. Primary diagnosis of organ confined untreated prostate cancer
4. Planned elective radical prostatectomy with bilateral nerve sparing technique
5. Negative urinalysis within 30 days prior to date of surgery
6. Patient has no erectile dysfunction (SHIM Score \< 14 ) prior to date of surgery
7. Patient has the willingness to comply with instruction of the investigator
8. Patient has the willingness to comply with follow-up surveys
9. Have ability to provide full written consent.
Exclusion Criteria:
1. High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
2. Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
3. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
4. Patients that have had prior hormonal therapy such as Lupron or oral anti-androgens
5. Patients with poor urinary control at baseline requiring the use of pads for leakage
6. Previous history of pelvic radiation
7. Previous history of simple prostatectomy or transurethral prostate surgery
8. Patients with obesity defined as BMI \> 40 kg/m2
9. History of open pelvic surgery within 5 years except for hernia repair
10. Poorly controlled diabetes (A1C \>8.5%)
11. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
12. Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
13. Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
14. In the opinion of the PI, has a history of drug or alcohol abuse within last 12 months
15. Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin)
16. Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT05081232
Study Brief:
Protocol Section:
NCT05081232