AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft

Launched by HACKENSACK MERIDIAN HEALTH · Feb 7, 2020

Keywords

ClinConnect Summary

The AMNIOX CORD Study is a clinical trial designed to explore whether using a special treatment called CLARIX® CORD 1K during a specific type of prostate surgery (robotic prostatectomy) can help men recover their erectile and urinary functions faster after the procedure. The study is focused on men aged 30 to 70 who have been diagnosed with localized prostate cancer and are scheduled for a nerve-sparing surgery, which aims to preserve these functions. Participants will be asked to share their experiences about their sexual and urinary health after the surgery to help researchers understand the treatment's effectiveness.

To be eligible for this trial, men need to have no significant issues with erectile function before surgery and must be willing to attend follow-up visits. Certain factors, such as previous pelvic surgery or specific medical conditions, may prevent someone from participating. If you decide to take part in the study, you can expect regular check-ins and questionnaires about your recovery. Overall, this trial aims to find ways to improve recovery for men undergoing prostate surgery, which could lead to better quality of life after treatment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male aged between 30 and 70 years old
• • 2. Primary diagnosis of organ confined prostate cancer
• • 3. Scheduled to undergo bilateral, nerve-sparing RARP
• • 4. Patient has ICIQ-SF score \<6
• • 5. Patient has no erectile dysfunction (defined as IIEF-6 score ≥ 26)
• • 6. Patient is willing to return for all visits as defined in the protocol
• • 7. Patient is willing to follow the instruction of the Investigator
• • 8. Patient has provided written informed consent
• Exclusion Criteria:
• • 1. Previous history of pelvic radiation
• • 2. Previous history of simple prostatectomy or transurethral prostate surgery
• • 3. Previous history of systemic therapy for prostate cancer
• • 4. Patient has neurogenic bladder
• • 5. Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
• • 6. History of open pelvic surgery within 5 years except for hernia repair
• • 7. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period.
• • 8. Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments
• • 9. 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
• • 10. Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin- B