Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
410
Countries
1
Sites
3
Benign prostatic hypertrophy
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
Key facts
- Sponsor
- Azienda Ospedaliero Universitaria Careggi, University Of Florence
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Decision date (initial)
- 2026-06-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- PIERRE FABRE MEDICAMENT SAS immatriculée en France sous le numéro 326 118 502 R.C.S Castres
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Efficacy, Therapy
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
Secondary objectives 2
- reduction of the entity of prostatic inflammation
- evaluate improvements in urinary symptoms and overall quality of life (QoL), and to assess the increased detection rate of clinically significant prostate cancer.
Conditions and MedDRA coding
Benign prostatic hypertrophy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10004446 | Benign prostatic hyperplasia | 100000004872 |
| 21.1 | LLT | 10004447 | Benign prostatic hypertrophy | 10038604 |
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Enrollment It consists of selection of participants based on inclusion criteria defined in the study protocol and acceptance of informed consent by the subject. Through informed consent, the patient agrees to participate in the study after being made aware of the nature and purpose of the study, the procedures involved, potential risks and discomforts, potential benefits, their rights and how their data will be handled.
|
Not Applicable | None | ||
| 2 | Randomization After the eligibility and enrollment are confirmed, the participant will be randomised in one of the 2 arms (two Permixon capsules or two placebo capsules taken orally with meals once-daily).
|
Randomised Controlled | Double | [{"id":192423,"code":2,"name":"Investigator"},{"id":192422,"code":1,"name":"Subject"},{"id":192424,"code":3,"name":"Monitor"},{"id":192425,"code":5,"name":"Carer"}] | Treatment arm: Permixon® 320 mg (two 160 mg capsules) should be taken orally once daily for 12 months. Placebo arm: Matching placebo (two capsules) should be taken orally once daily for 12 months. |
| 3 | Treatment period The participant will come on-site 3 times during the treatment period on month 3, month 6, month 9 and month 12 (end of treatment).
|
Randomised Controlled | Double | [{"id":192429,"code":5,"name":"Carer"},{"id":192430,"code":1,"name":"Subject"},{"id":192428,"code":3,"name":"Monitor"},{"id":192427,"code":2,"name":"Investigator"}] | Treatment arm: Permixon® 320 mg (two 160 mg capsules) should be taken orally once daily for 12 months. Placebo arm: Matching placebo (two capsules) should be taken orally once daily for 12 months. |
| 4 | Follow-up After the 12-months treatment period, the participant will have to complete a 6-month follow-up period without treatment.
|
Randomised Controlled | Double | [{"id":192433,"code":3,"name":"Monitor"},{"id":192434,"code":5,"name":"Carer"},{"id":192435,"code":2,"name":"Investigator"},{"id":192432,"code":1,"name":"Subject"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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
Exclusion criteria 15
- Unable or unwilling to sign the informed consent
- 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
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of patients undergoing a repeat prostate biopsy within 12 months
Secondary endpoints 7
- ln[PSA] value measured at 12 months
- PINS score at 12 months
- PIRADS score at 12 months
- Number of lesions at 12 months
- IS and IRANI score at 12 months
- IPSS and IIEF-5 at 12 months
- Proportion of patients diagnosed with prostate cancer within 12 months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD4624008 · Product
- Active substance
- Serenoa Repens (Bartram) Small.
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 116800 mg milligram(s)
- Max treatment duration
- 365 Day(s)
- Authorisation status
- Authorised
- ATC code
- G04CX02 — SERENOA REPENS
- Marketing authorisation
- 34009 334 495 8 2
- MA holder
- PIERRE FABRE MEDICAMENT
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The primary packaging is identical to the commercial packaging. The product is primary and secondary packaged, labelled and released by CREAPHARM Clinical Supplies.
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Ospedaliero Universitaria Careggi
- Sponsor organisation
- Azienda Ospedaliero Universitaria Careggi
- Address
- Largo Giovanni Alessandro Brambilla 3
- City
- Florence
- Postcode
- 50134
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Ospedaliero Universitaria Careggi
- Contact name
- Gacci Mauro
Public contact point
- Organisation
- Azienda Ospedaliero Universitaria Careggi
- Contact name
- Gacci Mauro
University Of Florence
- Sponsor organisation
- University Of Florence
- Address
- Largo Giovanni Alessandro Brambilla 3
- City
- Florence
- Postcode
- 50134
- Country
- Italy
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Pharma Quality Europe S.r.l. ORG-100046604
|
Milan, Italy | On site monitoring, Code 5, Data management, E-data capture, Code 8 |
Sponsor responsibilities
- Article 77 compliance
- Azienda Ospedaliero Universitaria Careggi
- Contact point sponsor
- Azienda Ospedaliero Universitaria Careggi
- Article 77 implementation
- Azienda Ospedaliero Universitaria Careggi
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 410 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
ASST Grande Ospedale Metropolitano Niguarda
Centro per la terapia dell’Ipertrofia Prostatica Benigna (IPB), Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliero-Universitaria Sant Andre
UOC Urologia, Via Di Grottarossa 1035-1039, 00189, Rome
Azienda Ospedaliero Universitaria Careggi
SOD Urologia e trapianti renali, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-525123-27 | 3.0 |
| Protocol (for publication) | D1_Questionnaire IIEF 5_International Index of Erectile Function Questionnaire | 1 |
| Protocol (for publication) | D1_Questionnaire IPSS_International Prostatic Symptoms Score | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF privacy informations | 2.0 |
| Subject information and informed consent form (for publication) | L2_MMG letter | 1 |
| Subject information and informed consent form (for publication) | L2_Subject wallet | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Permixon lipido-sterolic extract of Serenoa repens | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2025-525123-27 | 3.0 |
| Synopsis of the protocol (for publication) | D4_Lay language synopsis | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-04 | Italy | Acceptable 2026-06-22
|
2026-06-23 |