AuthorisedTherapeutic confirmatory (Phase III)Interventional

SERENDIPITY: phase III multicentric randomized study assessing the reduction of chronic prostate inflammation with Permixon®

An enlarged prostate is a very common condition in men as they get older. It can cause urinary troubles and ongoing swelling inside the prostate tissue. In some cases, doctors carry out a biopsy to rule out cancer. If inflammation persists, men may be advised to have another biopsy later on. This phase 3 study, called SERENDIPITY, tests whether a capsule called Permixon can reduce this swelling. Permixon is a plant-based medicine made from saw palmetto extract. Half of the men taking part will receive Permixon daily, while the other half will receive a dummy capsule (placebo). Over one year, the research team will track how many men need a second biopsy. They will also monitor blood test results, MRI scans, and urinary and sexual symptoms to see if Permixon provides meaningful relief and reduces the need for invasive procedures.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Azienda Ospedaliero Universitaria Careggi, University Of Florence

Enrolment target

410

Start

23 Jun 2026

Benign prostatic hypertrophy

What is this study about?

As men grow older, the prostate gland often gets bigger. This condition is called benign prostatic hypertrophy. While it is not cancer, an enlarged prostate can press against the bladder and the tube that carries urine out of the body. This can cause frequent trips to the toilet, a weak stream, or a feeling that the bladder is never fully empty. In many men, the prostate also develops long-lasting swelling, known as chronic inflammation.

When a doctor notices inflammation or raised prostate-specific antigen (PSA) levels in the blood, they may recommend a prostate biopsy to check for cancer cells. Even if the biopsy comes back clear, ongoing inflammation can keep PSA levels high or make follow-up scans look suspicious. Because of this uncertainty, many men end up having another biopsy within a year, which can be an uncomfortable and worrying experience.

The SERENDIPITY study is testing whether a medicine called Permixon can calm this inflammation. Permixon contains an extract from the berries of the saw palmetto plant and is designed to soothe prostate tissue. By reducing inflammation, doctors hope the medicine will stabilise test results and help men avoid unnecessary repeat biopsies.

This trial matters because repeat biopsies carry risks, including bleeding and infection. If Permixon proves successful, it could offer a gentle, daily capsule that improves day-to-day urinary symptoms while sparing men from repeated hospital procedures.

Key takeaways

The SERENDIPITY study tests whether Permixon can reduce prostate swelling over 12 months.
The main aim is to find out if the treatment reduces the need for a second prostate biopsy.
Half of the participants will take Permixon capsules, and half will take a dummy pill (placebo).
Health checks will include PSA blood tests, MRI scans, and symptom surveys.
Taking part is voluntary, and you can leave the study at any time without your regular care changing.

Who may be eligible?

This study is open to adult men aged 18 and over who have an enlarged prostate and signs of ongoing prostate inflammation.

Participants are usually men who have had prostate investigations in the past and are being closely watched by their urology team to see if another biopsy is needed.

Before taking part, the study doctors will check your overall health, review your previous prostate tests, and look at any other medicines you take to confirm that joining the trial is safe and right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

You are a man aged 18 or older.
You have been diagnosed with an enlarged prostate (benign prostatic hypertrophy).
You have ongoing swelling or inflammation in your prostate.
Your doctor is monitoring your prostate and considering whether a repeat biopsy is needed.
You are able to take a daily capsule and attend clinic visits over a 12-month period.

Answer every question to see your result.

What does participation involve?

Taking part in the SERENDIPITY study lasts for about 12 months. If you join, you will take one capsule every day. A computer will randomly choose whether you get Permixon or a placebo (a dummy pill containing no active medicine). Neither you nor your doctor can pick which one you receive. Over the year, you will visit the hospital clinic for regular check-ups. These visits will include routine blood tests to measure your PSA levels, an MRI scan to take clear pictures of your prostate, and short questionnaires about your bladder and sexual health. At the end of the 12 months, doctors will record whether you needed another prostate biopsy and compare how well both groups did.

Potential risks and benefits

Taking part may help improve your urinary symptoms and reduce swelling in your prostate, although this cannot be guaranteed—especially if you are taking the dummy capsule. Permixon is generally well tolerated, but some people might experience mild side effects such as stomach ache, nausea, or a headache. You will also need to attend clinic appointments for scans and tests. Your participation is completely voluntary, and you can change your mind and leave the study at any time without it affecting your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is Permixon?

Permixon is a capsule made from an extract of the saw palmetto plant. It is used to help soothe inflammation and ease urinary symptoms caused by an enlarged prostate.

Will I definitely receive the active medicine?

No. This is a randomised trial, which means you have an equal chance of receiving either Permixon or a matching dummy capsule (placebo) with no active drug.

Why is avoiding a repeat biopsy important?

Prostate biopsies can be uncomfortable, stressful, and carry small risks of bleeding or infection. Finding medicines that lower the need for repeat procedures is better for patients.

Can I still see my normal doctor during the trial?

Yes. You will continue to have access to your normal healthcare team, and your safety is always the top priority.

Does Permixon treat prostate cancer?

No. Permixon is designed for non-cancerous prostate enlargement and inflammation. It is not a treatment for prostate cancer.