PRP for Treatment of Peyronie's Disease

NCT04512287 | Completed Phase 2 FDA Drug

• 1 other identifier: 20200779
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).

Conditions

Peyronie Disease; Sexual Dysfunction, Physiological; Sexual Dysfunction Male; Genital Diseases, Male

Keywords

PD; PyD; PRP

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects in each group who attain degree change in penile curvature.

  Treatment efficacy of PRP will be assessed via the percentage of participants achieving degree change in penile curvature from baseline. Degree of curvature will be measured using a goniometer with the aid of injection of vasoactive substance into the penis.

  7 months

• Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).

  Treatment efficacy will be assessed via the percentage of participants achieving any decrease in Peyronie's disease Questionnaire (PDQ) sub-domain scoring from baseline. The sub-domains that will be assessed in primary outcome is Psychological and Physical Symptoms and Symptom Bother. PDQ is a validated 15-item questionnaire that assess Psychological and Physical Symptoms, Symptom Bother, and Penile Pain subdomains. The Psychological and Physical Symptoms subdomain is measured from 0 to 24 (most severe symptoms). Symptom Bother subdomain is measured from 0 to 30 (most severe pain).

  7 months

Secondary Outcomes (1)

• Incidence of adverse events in all patients

  Baseline, 6 months (post-intervention)

Study Arms (2)

Experimental: Autologous PRP followed by Placebo Group

EXPERIMENTAL

Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later.

Drug: Autologous Platelet Rich Plasma; Other: Saline Solution

Experimental: Placebo followed by Autologous PRP Group

EXPERIMENTAL

Participants in this group will receive the placebo intervention first, followed by the Autologous PRP intervention 3 months later.

Drug: Autologous Platelet Rich Plasma; Other: Saline Solution

Interventions

Autologous Platelet Rich Plasma DRUG

2 sessions of Autologous PRP will be administered 15 days apart. Each injection will be 0.5 mL of PRP injected into the Peyronie's disease penile plaque.

Also known as: PRP

Experimental: Autologous PRP followed by Placebo Group; Experimental: Placebo followed by Autologous PRP Group

Saline Solution OTHER

2 sessions of saline injection will be administered 15 days apart. Each injection will be 0.5 mL of normal saline injected into the Peyronie's disease penile plaque.

Experimental: Autologous PRP followed by Placebo Group; Experimental: Placebo followed by Autologous PRP Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be Male
• Be 18 to 75 years of age (inclusive).
• Be able to provide written informed consent
• Have a diagnosis of PD with evidence of active or stable disease as determined by the investigator
• Penile curvature deformity of \>30° to \<120°
• Agree to comply with all study related tests/procedures.

You may not qualify if:

• Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
• Previous intralesional injection therapy (such as Xiaflex) for PD.
• Previous history of priapism or penile fracture
• PD characterized by a ventral plaque
• Severe erectile dysfunction as characterized with an International Index of Erectile Function (IIEF) score ≤ 16
• Actively on anticoagulation during time frame of injections (aspirin 81 mg will be eligible for therapy)
• Hour-glass deformity
• Unwilling to participate
• Medically unfit for sexual intercourse as deemed by the principal investigator
• Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
• Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Chu KY, Molina ML, Ledesma B, Zucker I, Saltzman RG, Masterson TA, Ramasamy R. A Phase 2 Randomized, Placebo-controlled Crossover Trial to Evaluate Safety and Efficacy of Platelet-rich Plasma Injections for Peyronie's Disease: Clinical Trial Update. Eur Urol Focus. 2023 Jan;9(1):11-13. doi: 10.1016/j.euf.2022.08.017. Epub 2022 Sep 10.

  PMID: 36100520 DERIVED

MeSH Terms

Conditions

Penile Induration; Sexual Dysfunction, Physiological; Genital Diseases, Male

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Manuel Molina, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physician

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 13, 2020
• Study Start: March 29, 2021
• Primary Completion: August 11, 2025
• Study Completion: August 11, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)