Ongoing Clinical Trials for Peyronie’s Disease
There are currently 2 clinical trials underway investigating new approaches to diagnose and treat Peyronie’s Disease, a condition that causes curved, painful erections due to fibrous scar tissue in the penis. These trials are being conducted in Italy and the Netherlands, exploring both enzyme-based treatments to break down plaque and advanced imaging techniques to better detect active disease.
Clinical trial locations
- Italy
- Netherlands
Study on the Safety and Effectiveness of Vibrio Alginolyticus Collagenase and Alprostadil for Patients with Peyronie’s Disease
This trial is taking place in Italy and focuses on testing a treatment that uses an enzyme called Vibrio alginolyticus collagenase combined with Alprostadil. The enzyme is injected directly into the plaque that causes the penile curvature, with the goal of breaking down the scar tissue and reducing the bend.
Who can participate: This study is looking for men aged 18 or older who have had a stable penile curvature between 30 and 90 degrees for at least 12 months without pain during erection. Participants need to score 17 or higher on a specific questionnaire about erectile function and must have been in a stable relationship for at least 3 months. You must be willing to follow specific instructions, including avoiding sexual activity for 15 days after each injection and using contraception if your partner can have children.
Who cannot participate: The trial is only open to male participants. Those outside the specified age range or who belong to vulnerable populations requiring special protection cannot join.
What the trial involves: The study is divided into two phases. In the first phase, researchers will test different doses of the enzyme to find the safest and most effective amount. In the second phase, participants will receive multiple injections using this optimal dose. Depending on the treatment regimen, you may receive either three or eight injections over the course of the study. Regular check-ups will monitor changes in penile curvature, side effects, and overall quality of life. The study aims to continue until 2027.
Investigational treatment: The main medication being tested is Vibrio alginolyticus collagenase, which works by breaking down the collagen in the fibrous plaque. Alprostadil is used to induce erections so that doctors can accurately measure changes in curvature.
Study on the Use of FAPI-PET/CT and FDG-PET/CT Scans for Detecting Active Fibroblasts and Inflammation in Patients with Acute Phase Peyronie’s Disease
This trial is being conducted in the Netherlands and explores the use of advanced imaging scans to better diagnose the condition during its early, active phase. The study uses two types of scans—FAPI-PET/CT and FDG-PET/CT—to detect areas of active tissue remodeling and inflammation in the penis.
Who can participate: This study is seeking men over 18 years old who have been experiencing painful erections for less than 6 months and have a lump that can be felt in the penis. Participants must be mentally competent, able to understand the study’s benefits and potential risks, and capable of reading and understanding Dutch.
Who cannot participate: Only male participants within the specified age range can join. Those without the condition, females, and individuals belonging to vulnerable populations are excluded.
What the trial involves: After providing written consent and undergoing an initial assessment to confirm eligibility, participants will receive two types of imaging scans. For the FAPI-PET/CT scan, a special solution called [68Ga]FAPI-46 is injected into a vein. This helps highlight areas where fibroblasts—cells involved in scar tissue formation—are actively working. The FDG-PET/CT scan detects areas of inflammation by tracking metabolic activity in the tissues. Follow-up appointments will discuss the scan results and help evaluate how effective these imaging techniques are at identifying active disease.
Investigational approach: Rather than testing traditional medications, this trial evaluates diagnostic imaging techniques. The FAPI-PET/CT scan targets fibroblast activation protein, while the FDG-PET/CT scan uses a glucose-based tracer to show areas of increased metabolic activity associated with inflammation.
Summary
These two clinical trials represent different approaches to addressing Peyronie’s Disease. The Italian study focuses on developing a treatment that directly breaks down the plaque causing penile curvature through enzyme injections, while the Dutch study aims to improve diagnostic capabilities by using advanced imaging to identify active disease in its early stages. Together, these trials offer hope for both better detection and more effective treatment options for men living with this condition.
The trials are geographically diverse, with one in Italy and one in the Netherlands, making them accessible to patients in different parts of Europe. The Italian trial is a longer-term study continuing until 2027, while the Dutch study focuses on perfecting diagnostic techniques that could help guide future treatment decisions. Both trials are specifically designed for men with the condition and have clear criteria regarding disease stage and severity.
