Platelet Rich Plasma During Radical Prostatectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - 60 |
| Updated: | 3/13/2019 |
| Start Date: | December 2016 |
| End Date: | June 2019 |
| Contact: | Tessa Kroeninger |
| Email: | Kroeninger.tessa@mayo.edu |
| Phone: | 507-538-6107 |
A Study Evaluating Intraoperative Application of Platelet-Rich Plasma to the Neurovascular Bundles During Nerve-Sparing Radical Prostatectomy: Initial Technical Description and Prospective Early Postoperative Outcomes Analysis
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.
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.
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
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Phone: 507-538-6107
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