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Effect of serenoa repens on chronic prostate inflammation in men with benign prostatic hyperplasia: a phase III randomized study

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at men with Benign prostatic hypertrophy, a non‑cancerous enlargement of the prostate that can cause urinary problems. The investigational medicine is Permixon, a capsule that contains the plant extract serenoa repens and is taken by mouth.

The aim is to see whether treatment can lower the need for a repeat prostate biopsy by reducing prostate inflammation and related markers. Participants will be randomly assigned to receive either the active capsule or an inert matching capsule (placebo) for about one year, with regular check‑ups.

During the study, men will take one capsule each day and attend clinic visits where blood will be drawn to measure PSA (a protein that can indicate prostate activity), and imaging with MRI will be performed to assess the PIRADS score, a system that rates how likely a lesion is to be cancer. They will also complete questionnaires such as the IPSS (which rates urinary symptoms) and the IIEF-5 (which assesses erectile function). The study will track whether a repeat biopsy is needed and any changes in these measurements over the 12‑month period.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and receipt of study medication
After enrollment, the study assigns the participant to one of two groups: the permixon group or the placebo group.
The assigned medication is provided in a hard capsule that must be taken by mouth.
Step 2
Start of medication intake
The participant begins taking one capsule each day.
The permixon capsule contains 320 mg of serenoa repens; the placebo capsule contains 350 mg of macrogol 6000 and no active ingredient.
Step 3
Daily medication routine
The capsule is swallowed with water, preferably at the same time each day.
The daily intake continues for a total duration of twelve months.
Step 4
Scheduled clinic visits
The participant attends follow‑up visits at approximately month 3, month 6, and month 12.
Each visit includes a safety check, a blood test to measure psa (prostate specific antigen), and a review of any side effects.
Step 5
Mid‑study assessments
At the month 6 visit, the investigator may perform additional examinations to evaluate prostate health, such as a physical exam or symptom questionnaires.
Step 6
Final imaging and laboratory evaluation
At the month 12 visit, an mri (magnetic resonance imaging) of the prostate is performed to assess any changes in the tissue.
A final blood sample is taken to measure the psa level.
Step 7
Repeat prostate biopsy (if required)
Based on the month 12 imaging and laboratory results, a repeat prostate biopsy may be scheduled.
The biopsy involves taking a small tissue sample from the prostate to determine whether further treatment is needed.
Step 8
Study completion
After the twelve‑month treatment period and any required final assessments, the participant’s involvement in the study ends.
All collected data are used to evaluate the effect of permixon on chronic prostate inflammation.

Who can join the trial?

6 criteria

Be a male aged 45 to 85 years who has lower urinary tract symptoms (LUTS) caused by benign prostatic hypertrophy (BPH).
Sign and date a written informed consent form agreeing to join the study.
Have a blood test showing a total PSA level greater than 4 ng/mL (the test must be done within the last 6 months).
Or have a prostate MRI that shows a score of PIRADS 3 or higher on a multiparametric MRI (mpMRI) performed within the last 6 months.
Have had a prostate tissue sample taken (a prostate biopsy) no more than 4 months before being randomly assigned to treatment.
The biopsy must show chronic non‑specific inflammation when examined under a microscope and must show no evidence of prostate cancer (PCa).

Who cannot join the trial?

15 criteria

Unable or unwilling to sign the informed consent (a document that shows you agree to join the study).
Have had or plan to have prostatic surgery for urinary symptoms caused by an enlarged prostate (called LUTS/BPH).
Have bladder problems that can cause infections, such as bladder diverticula or a bladder that does not empty properly because of nerve issues.
Had a urinary tract infection (UTI) caused by bacteria that are resistant to many antibiotics within the last 3 months.
Have any condition that weakens the immune system (immunosuppression).
Regularly take anti‑inflammatory drugs (like ibuprofen) for a long time.
Have a history of cancer or a suspected spread of cancer (metastatic disease).
Did not have a blood test for PSA (prostate‑specific antigen) and a special MRI of the prostate (mpMRI) within 6 months before joining the study.
Cannot follow a long‑term treatment plan.
Previously used Permixon® and stopped it less than 12 months before joining the study.
Are allergic to the active ingredient or any other part of Permixon®.
Are currently using 5‑ARIs (medications that shrink the prostate) or stopped them less than 2 months before the baseline PSA test.
Have been diagnosed with prostate cancer (PCa), high‑grade prostatic intraepithelial neoplasia (PIN HG), or atypical small acinar proliferation (ASAP).
Had a prostate biopsy more than 4 months before joining the study.
Had a prostate biopsy that showed no chronic inflammation or that showed cancer.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

ASST Grande Ospedale Metropolitano Niguarda
Verified
Milan, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Azienda Ospedaliero-Universitaria Sant Andre
Responsive
Rome, Italy

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Investigated drugs

Permixon is an oral capsule that contains an extract from the saw‑palmetto plant (serenoa repens). In this study, participants take the capsule once a day for a year. The purpose of the medication is to reduce chronic inflammation of the prostate. By lowering inflammation, the researchers hope it will decrease the need for a repeat prostate biopsy, either by improving MRI findings or by lowering PSA levels.

What is already known about the treatment

Permixon 160 mg - This medication is taken by mouth as a hard capsule, usually one capsule daily. It contains an extract of the plant Serenoa repens (saw‑palmetto) and is currently available in many countries as an over‑the‑counter or prescription product for benign prostatic hypertrophy, with many clinical studies supporting its use. The extract works mainly by gently blocking the enzyme that changes testosterone into a stronger form called dihydrotestosterone, and it also helps lower inflammation in the prostate. It is classified as a phytotherapeutic (herbal) agent and a mild 5‑alpha‑reductase inhibitor, used to improve urinary symptoms caused by an enlarged prostate.

Investigated diseases

Benign prostatic hyperplasia - A non-cancerous enlargement of the prostate gland that commonly occurs as men age. The growing tissue can press on the urethra, making it harder for urine to flow. Over time, the bladder may work harder to empty, leading to a feeling of incomplete emptying. The condition often progresses slowly, with symptoms becoming more noticeable as the prostate continues to enlarge.