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SERENDIPITY: phase III multicentric randomized study assessing the reduction of chronic prostate inflammation with Permixon®
EU CTIS ID: 2025-525123-27-00
What this study is testing
Reduction of the necessity to perform a new prostate biopsy evaluated with the downgrade of the PIRADS area at MRI and/or the potential reduction of the PSA value (re-biopsy compared between groups) after 12 months of Permixon® treatment
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male patients aged between 45 and 85 with LUTS/BPH
- Who signed and dated informed consent for participation in the trial obtained according to ICH GCP, and national/local regulations
- Total PSA value > 4 ng/mL (data collected within 6 months from the inclusion) and/or PIRADS areas ≥3 at mpMRI (data collected within 6 months from the inclusion).
- Who underwent a prostate biopsy within 4 months from randomization
- Histologically confirmed chronic non-specific inflammation and absence of PCa
You likely can't join if
- Unable or unwilling to sign the informed consent
- Personal history of or planned prostatic surgery for LUTS/BPH
- Pathological bladder conditions that can promote infectious diseases (i.e.: diverticula, neurological bladder, etc.).
- Personal history of UTIs caused by multi-resistant bacteria less than 3 months prior to randomization
- Any form of immunosuppression
- Use of chronic therapy with anti-inflammatory drugs
See the full eligibility criteria
- Male patients aged between 45 and 85 with LUTS/BPH
- Who signed and dated informed consent for participation in the trial obtained according to ICH GCP, and national/local regulations
- Total PSA value > 4 ng/mL (data collected within 6 months from the inclusion) and/or PIRADS areas ≥3 at mpMRI (data collected within 6 months from the inclusion).
- Who underwent a prostate biopsy within 4 months from randomization
- Histologically confirmed chronic non-specific inflammation and absence of PCa
- Unable or unwilling to sign the informed consent
- Personal history of or planned prostatic surgery for LUTS/BPH
- Pathological bladder conditions that can promote infectious diseases (i.e.: diverticula, neurological bladder, etc.).
- Personal history of UTIs caused by multi-resistant bacteria less than 3 months prior to randomization
- Any form of immunosuppression
- Use of chronic therapy with anti-inflammatory drugs
- Personal history of cancer or suspected metastatic disease
- Who not underwent to total serum PSA determination and mpMRI within 6 months from randomization
- Not suited to follow a long-term treatment
- Previous treatment with Permixon®, discontinued less than 12 months prior to randomization
- Allergy to the active substance or to any of the other components of Permixon®.
- Active treatment with 5-ARIs or discontinued less than 2 months prior to total serum PSA determination baseline
- Diagnosis of PCa, PIN HG (Prostatic Intraepithelial Neoplasia High-Grade) and/or ASAP (Atypical Small Acinar Proliferation).
- Prostate biopsy performed more than 4 months prior to randomization
- Negative prostate biopsy for chronic inflammation or positive for malignancy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.