Randomized AmnioFix Study During Radical Prostatectomy (NCT02645591) | Clinical Trial Compass
WithdrawnPhase 2
Randomized AmnioFix Study During Radical Prostatectomy
0Started 2016-11
Plain-language summary
The goal of this clinical research study is to learn about the safety and the effectiveness of using AmnioFix® (dehydrated human amnion/chorion membrane, also called dHACM) to help improve the return of erectile function and bladder control in patients after robotic assisted laparoscopic radical prostatectomy (RARP).
dHACM is a section of tissue made from part of the placenta donated by a mother during a C-section. It looks like a small piece of tissue paper and is wrapped around the nerve bundles in the surgical area. The tissue may help the body's normal healing process.
Who can participate
Age range35 Years – 75 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male subjects between the ages 35-75
✓. Primary diagnosis of prostate cancer selected for surgical intervention by one of the six protocol surgeons (Chapin, Davis, Matin, Pettaway, Pisters, Ward).
✓. Have a willingness to comply with follow-up HRQOL (health related quality of life) surveys and PSA assessments.
✓. Have ability to provide full written consent.
✓. Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, 7,8 or 9.
✓. Planned elective radical prostatectomy with bilateral nerve sparing technique that can include high or low fascia.
✓. Negative urinalysis within 30 days prior to date of surgery
Exclusion criteria
✕. High-risk cancer planned for neoadjuvant therapy, full or partial excision of one or both neurovascular bundles.
✕. 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.
✕. Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications.
✕. In the opinion of the PI, has a history of drug or alcohol abuse within last 12 months.
What they're measuring
1
Reducing Neurovascular Bundle Inflammation in Prostate Cancer Patients Undergoing Nerve Sparing Robotic Assisted Laparoscopic Radical Prostatectomy (RARP)
✕. Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin).
✕. 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.
✕. Patients currently enrolled in another study. Concurrent enrollment in another study is prohibited expect for the control arm which can be used for other protocols with HRQOL endpoints with similar instruments.
✕. Has had prior hormonal therapy such as Lupron or oral anti-androgens.