Prostate CancerNCT02957149

Platelet Rich Plasma During Radical Prostatectomy

A study testing Autologous Platelet-Rich Plasma and Angel Concentrated Platelet Rich Plasma System in people with Prostate Cancer, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 60 years, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Autologous Platelet-Rich Plasma and Angel Concentrated Platelet Rich Plasma System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Dec 2016to 21 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 60 years
Men only
No healthy volunteers
Adult

Who may be able to join

Newly diagnosed, clinically localized prostatic adenocarcinoma
Age 50 - 60 years
Male gender
Normal preoperative sexual function
Normal urinary continence

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Conditions: Prostate Cancer
Being tested: Autologous Platelet-Rich Plasma, Angel Concentrated Platelet Rich Plasma System
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous Platelet-Rich PlasmaOther
Also called PRP
Platelets that are collected from the subject during the radical prostatectomy, for prostate cancer. The platelets are concentrated in a device to 1,000,000 platelets/mL and applied topically once to the neurovascular bundle during the surgery.
Angel Concentrated Platelet Rich Plasma SystemDevice

Study groups in NCT02957149
Study group	Role	What they receive
Platelet Rich Plasma (PRP) Treatment	Experimental	Platelets that are collected from the subject during the radical prostatectomy, for prostate cancer. The Autologous Platelet-Rich Plasma is concentrated in a device (Angel Concentrated Platelet Rich Plasma System) to 1,000,000 platelets/mL and applied topically once to the neurovascular bundle during the surgery. Receives: Other: Autologous Platelet-Rich Plasma; Device: Angel Concentrated Platelet Rich Plasma System

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB)
Assessed by the number of subjects experiencing serious adverse events (SAEs) after treatment with PRP following nerve-sparing radical prostatectomy
Measured: 18 months

Secondary outcomes (2)

Change in Sexual Function Using International Index of Erectile Function (IIEF-5)
The IIEF-5 (International Index of Erectile Function) is used for diagnosis of erectile dysfunction (ED). The IIEF-5, also knows as the Sexual Health Inventory for Men (SHIM), is a 5-question survey designed to assess the presence and severity of ED over the past 6 months. Questions are answered on a scale of 1-5. A score of 21 or lower is often considered indicative of ED. The IIEF-5 classifies ED into five categories based on scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
Measured: Baseline; every 3 months up to 18 months.
Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC)
The Urinary Function (UF) section of the Expanded Prostate Cancer Index composite (EPIC) questionnaire consists of 7 questions evaluating urinary habits over the past 4 weeks. To assess change in UF over time, evaluation focused on response to question 5 (number of pads or adult diapers used to control leakage), with normal urinary continence defined as a response of "none" per protocol. Responses are recorded on a scale of 0-3 where 0=None, 1=1 pad per day; 2=2 pads per day; and 3=3 or more pads per day.
Measured: Baseline; 3 months; 6 months; 9 months; 12 months; 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201621 Dec 2022

First posted7 Nov 2016 (estimated)
Study startDec 2016
Primary completion21 Dec 2022
Study completion21 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02957149
Sponsor's protocol ID: MC2051
Other IDs: MC2051, NCI-2020-00836, 16-001320
Status last verified: Jun 2025
First submitted: 3 Nov 2016
Last updated: 5 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma

All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02957149
Acronym / sponsor ID: MC2051
Conditions: Prostate Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: Dec 2016 (actual)
Primary completion: 21 Dec 2022 (actual)
Study completion: 21 Dec 2022 (actual)
First posted: 7 Nov 2016 (estimated)
Results: Posted 5 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Platelet Rich Plasma (PRP) Treatment	Experimental	Other: Autologous Platelet-Rich Plasma, Device: Angel Concentrated Platelet Rich Plasma SystemPlatelets that are collected from the subject during the radical prostatectomy, for prostate cancer. The Autologous Platelet-Rich Plasma is concentrated in a device (Angel Concentrated Platelet Rich Plasma System) to 1,000,000 platelets/mL and applied topically once to the neurovascular bundle during the surgery.

Who may qualify

Ages: 50 to 60 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Newly diagnosed, clinically localized prostatic adenocarcinoma
Age 50 - 60 years
Male gender
Normal preoperative sexual function
Normal urinary continence

Key exclusion criteria (13 listed)

Unable or unwilling to provide informed consent
Vulnerable study populations
Active systemic infection
Diabetes mellitus diagnosis
Preexisting Erectile Dysfunction or urinary incontinence

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Autologous Platelet-Rich PlasmaAlso: PRPPlatelets that are collected from the subject during the radical prostatectomy, for prostate cancer. The platelets are concentrated in a device to 1,000,000 platelets/mL and applied topically once to the neurovascular bundle during the surgery.	Other	Platelet Rich Plasma (PRP) Treatment
Angel Concentrated Platelet Rich Plasma System	Device	Platelet Rich Plasma (PRP) Treatment

Primary outcome

Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB)
Time frame: 18 months
Assessed by the number of subjects experiencing serious adverse events (SAEs) after treatment with PRP following nerve-sparing radical prostatectomy

2 secondary outcomes

Change in Sexual Function Using International Index of Erectile Function (IIEF-5)
Time frame: Baseline; every 3 months up to 18 months.
Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC)
Time frame: Baseline; 3 months; 6 months; 9 months; 12 months; 18 months

Results and safety

Results posted to the registry on 5 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Platelet Rich Plasma (PRP) Treatment	24	19

Primary outcome: Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB)

Time frame: 18 months. Count of participants. Unit: Participants

Measure	Platelet Rich Plasma (PRP) Treatment n = 19
Grade 3 or higher AE (severe or life-threatening)	0
Grade 1 or 2 AE (mild or moderate)	2
No AE	17

Population analysed: The highest grade of adverse event (AE) is reported for each participants who experienced one or more AE.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Platelet Rich Plasma (PRP) Treatment	0 of 19 (0%)	2 of 19 (10.5%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Prostate Cancer

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew T. Gettman, M.D. principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Autologous Platelet-Rich Plasma and Angel Concentrated Platelet Rich Plasma System in people with Prostate Cancer, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02957149.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.