Platelet-rich plasma injections for Peyronie's disease
Treatment of Peyronie's Disease With Platelet-Rich Plasma: A Randomized, Double-blind, Placebo-controlled Clinical Trial
NA · Herlev Hospital · NCT07117955
This will test whether injections of a man's own platelet-rich plasma can reduce penile curvature and plaque in men with stable (fibrotic phase) Peyronie's disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Herlev Hospital (other) |
| Locations | 1 site (Herlev) |
| Trial ID | NCT07117955 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind trial will enroll 84 men with stable (fibrotic phase) Peyronie's disease and palpable plaque, stratified by baseline curvature (30–60° vs >60°). Participants are randomized 1:1 to receive three weekly intralesional injections of either autologous platelet-rich plasma (PRP) or saline placebo. Outcomes are measured at a 3-month primary follow-up with additional assessments at 6 and 12 months to capture durability of any effect. The protocol includes baseline questionnaires, objective exams, and follow-up visits to compare changes in curvature, plaque characteristics, and related symptoms between groups.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 or older with stable (nonprogressing) Peyronie's disease in the fibrotic phase, a palpable penile plaque, and a curvature between 30° and 95° who can attend in-person visits and have not had prior injectable or surgical PD treatments.
Not a fit: Patients with active painful or rapidly progressing disease, hourglass or intrapenile deformities, severely calcified plaques that cannot be injected, prior PD injections or surgery, or erectile dysfunction unresponsive to on-demand PDE5 inhibitors are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, PRP injections could offer a minimally invasive option to reduce curvature and improve symptoms for men with stable Peyronie's disease.
How similar studies have performed: Small case series and uncontrolled studies have reported symptomatic improvements with PRP for Peyronie's disease, but high-quality randomized evidence is currently limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Be able to provide written informed consent * Diagnosis of PD without active pain and without progressive curvature over the past 3 months (fibrotic phase). * Penile curvature of 30-95 degrees * Clearly palpable penile plaque Exclusion Criteria: * Erectile Dysfunction unresponsive to on-demand PDE5 inhibitors * Hourglass malformation * Severely calcified plaques where injection is considered unfeasible * Intrapenile plaque * History of priapism. * History of penile fracture. * Previous treatment for PD with injections and/or surgery. * Antithrombotic therapy associated with a high risk of bleeding
Where this trial is running
Herlev
- Herlev and Gentofte University Hospital — Herlev, Denmark (RECRUITING)
Study contacts
- Principal investigator: Mikkel M. Fode, Professor, MD, Ph.d. — Herlev and Gentofte University Hospital
- Study coordinator: Mikael Heering, MD, Ph.d. student
- Email: mikael.heering@regionh.dk
- Phone: +4538688964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peyronies Disease, Andrology, Platelet-Rich Plasma, Penile induration, PRP