Trial Outcomes & Findings for Platelet Rich Plasma During Radical Prostatectomy (NCT NCT02957149)

NCT ID: NCT02957149

Last Updated: 2025-06-05

Results Overview

Assessed by the number of subjects experiencing serious adverse events (SAEs) after treatment with PRP following nerve-sparing radical prostatectomy

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2025-06-05

Participant Flow

Participant milestones

Measure	Platelet Rich Plasma (PRP) Treatment 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. Autologous Platelet-Rich Plasma: 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 System
Overall Study STARTED	24
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure

Platelet Rich Plasma (PRP) Treatment 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. Autologous Platelet-Rich Plasma: 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 System

Overall Study Withdrawal by Subject

5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Platelet Rich Plasma (PRP) Treatment n=19 Participants 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. Autologous Platelet-Rich Plasma: 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 System
Age, Continuous	60 years n=19 Participants
Sex: Female, Male Female	0 Participants n=19 Participants
Sex: Female, Male Male	19 Participants n=19 Participants
Region of Enrollment United States	19 participants n=19 Participants

PRIMARY outcome

Timeframe: 18 months

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

Assessed by the number of subjects experiencing serious adverse events (SAEs) after treatment with PRP following nerve-sparing radical prostatectomy

Outcome measures

Measure	Platelet Rich Plasma (PRP) Treatment n=19 Participants 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. Autologous Platelet-Rich Plasma: 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 System
Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB) Grade 3 or higher AE (severe or life-threatening)	0 Participants
Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB) Grade 1 or 2 AE (mild or moderate)	2 Participants
Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB) No AE	17 Participants

SECONDARY outcome

Timeframe: Baseline; every 3 months up to 18 months.

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).

Outcome measures

Measure	Platelet Rich Plasma (PRP) Treatment n=19 Participants 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. Autologous Platelet-Rich Plasma: 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 System
Change in Sexual Function Using International Index of Erectile Function (IIEF-5) Baseline	25 score on a scale Interval 25.0 to 25.0
Change in Sexual Function Using International Index of Erectile Function (IIEF-5) 3 months	16 score on a scale Interval 8.5 to 20.0
Change in Sexual Function Using International Index of Erectile Function (IIEF-5) 6 months	19 score on a scale Interval 12.5 to 21.5
Change in Sexual Function Using International Index of Erectile Function (IIEF-5) 9 months	19 score on a scale Interval 14.0 to 21.5
Change in Sexual Function Using International Index of Erectile Function (IIEF-5) 12 months	20 score on a scale Interval 18.0 to 24.0
Change in Sexual Function Using International Index of Erectile Function (IIEF-5) 18 months	20 score on a scale Interval 18.0 to 22.5

SECONDARY outcome

Timeframe: Baseline; 3 months; 6 months; 9 months; 12 months; 18 months

Population: 4 patients were lost to follow-up for the last visit (18 months)

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.

Outcome measures

Measure	Platelet Rich Plasma (PRP) Treatment n=19 Participants 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. Autologous Platelet-Rich Plasma: 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 System
Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) Baseline	18 Participants
Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) 3 Months	9 Participants
Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) 6 Months	15 Participants
Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) 9 Months	18 Participants
Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) 12 Months	18 Participants
Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) 18 Months	15 Participants

Adverse Events

Platelet Rich Plasma (PRP) Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Platelet Rich Plasma (PRP) Treatment n=19 participants at risk 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. Autologous Platelet-Rich Plasma: 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 System
Gastrointestinal disorders Abdominal pain	5.3% 1/19 • Number of events 1 • 18 months Patients were followed from enrollment up to 18 months. We grade all the AEs using the CTCAE. 2 patients developed an AE, one patient experienced 2 grade 1 AEs and a single grade 2 AE; the second patient had a single grade 2 AE.
Renal and urinary disorders Interstitial Cystitis (Acute)	5.3% 1/19 • Number of events 1 • 18 months Patients were followed from enrollment up to 18 months. We grade all the AEs using the CTCAE. 2 patients developed an AE, one patient experienced 2 grade 1 AEs and a single grade 2 AE; the second patient had a single grade 2 AE.
Renal and urinary disorders Hematuria	5.3% 1/19 • Number of events 1 • 18 months Patients were followed from enrollment up to 18 months. We grade all the AEs using the CTCAE. 2 patients developed an AE, one patient experienced 2 grade 1 AEs and a single grade 2 AE; the second patient had a single grade 2 AE.
Renal and urinary disorders Dysuria	5.3% 1/19 • Number of events 1 • 18 months Patients were followed from enrollment up to 18 months. We grade all the AEs using the CTCAE. 2 patients developed an AE, one patient experienced 2 grade 1 AEs and a single grade 2 AE; the second patient had a single grade 2 AE.

Additional Information

Matthew Gettman, MD

Mayo Clinic

Phone: 507-284-3249

Email: Gettman.Matthew@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place