Prostate Cancer Clinical Trial
Platelet Rich Plasma During Radical Prostatectomy
Summary
Can platelet rich plasma applied to nerve bundles at time of surgery help the nerve bundles heal? Subjects undergoing a Radical Prostatectomy who meet study inclusion/exclusion criteria will be consented to receive an intraoperative application of platelet-rich plasma, made from their own blood at the time of surgery, for application onto their neurovascular bundles in an effort to improve the healing process. Subjects will be followed for an additional 18 months to determine the efficacy and safety of this procedure.
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed, clinically localized prostatic adenocarcinoma
Age 50 - 60 years
Male gender
Normal preoperative sexual function
Normal urinary continence
Regular sexual partner
Exclusion Criteria:
Unable or unwilling to provide informed consent
Vulnerable study populations
Active systemic infection
Diabetes mellitus diagnosis
Preexisting Erectile Dysfunction or urinary incontinence
Metastatic or locally advanced prostatic adenocarcinoma on preoperative evaluation
Men found grossly or pathologically to have locally advanced or metastatic disease at the time of radical prostatectomy
An estimated blood loss of > 750 mL at the time of radical prostatectomy
Treatment prior to surgery with any form of hormones, anti-androgens or androgen deprivation therapy
Use of an antidepressant, beta blocker or erectile dysfunction medication at the time of study screening
Men without a regular sexual partner
Use of aspirin or heparin 2 weeks before radical prostatectomy
Need for use of aspirin or heparin for 2 weeks or more after radical prostatectomy
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There is 1 Location for this study
Rochester Minnesota, 55905, United States
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