Call for participants for upcoming research at Institute for Human Genetics

Hello all,

After consultation with researchers and clinicians who will be leading upcoming research at The Institute for Human Genetics, University Medical Center Schleswig-Holstein in Kiel, we are putting a call out for study participants.

Since our application to use samples previously collected by Baylor was rejected, we’ve spent the past few months figuring out the best way forward. This process is complex and time consuming and we thank the community for their patience. While our plans are not confirmed, we have a commitment from a German clinician to assist with collecting new samples, pending approval of an ethics proposal for his involvement. He is an accomplished urologist who frequently sees PFS patients in his practice, is familiar with the clinical picture and eager to help. We are very pleased he will be involved.

I must stress however that nothing is confirmed until our ethics proposal has been approved. We are putting the finishing touches on our proposal and it will likely be submitted in the coming weeks.

With that said, we are ready to start recruiting patients to participate. If you would like to participate, please read the following carefully.

Criteria for participation

We will be prioritising samples which are most likely to deliver meaningful insights, and those located in Europe or the UK. The key criteria for consideration are:

  • Age. Researchers have asked us to prioritise younger patients, ideally 36 or younger.
  • Extent and severity of symptoms. Researchers have asked us to prioritise patients who demonstrate multi-systemic symptoms which are severe in nature and have endured since onset of PFS.
  • Duration of use. Researchers have asked us to prioritise patients who took the drug for a short period of time.
  • Used finasteride or dutasteride. As these are the most powerful class of anti-androgens, we will prioritise fin/dut users.

If you don’t meet every criteria perfectly, please still apply. While this is the ideal criteria, we may make exceptions if certain criteria are met. For example, you may have taken the drug 2 years but have dozens of severe symptoms and are in your mid-20s.

We will be prioritising patients in the UK/EU because of their proximity to Hamburg, where samples will be collected.

If you would like to be considered, please send us an email to contact@pfsnetwork.org (NOT A PM) outlining the following:

  • Your age
  • How long you took the drug for
  • A list of your current symptoms, the severity of each and whether these symptoms have endured since onset
  • Your location
  • Your ability to cover travel costs (can you cover cost of transport, accommodation and meals in full, partly, or not at all)

Please keep your list of symptoms brief and avoid explanations of each symptom. List each symptom in bullet point form along with severity and whether it has endured.

The procedures

The procedure is non-invasive. We will be taking a 0.25cm x 0.25cm piece of penile tissue. It doesn’t matter if you are circumcised. We may also take a blood sample for future research. The procedure will only take 1-2 hours including the completion of a clinical survey, so you will only need to stay max 1 night in Hamburg. There is comfortable, cheap apartment accommodation 1 block from the hospital, recommended by the doctor involved, which costs €85 per night. The doctor involved has indicated we will most likely be able to book a block of procedures of a 1-2 week period, and several procedures will take place each day.

You will need to complete a phone consultation before your procedure, which will take 30 mins to an hour. You will then provide consent via email.

Dates

Dates are TBD pending approval of ethics proposal, however we are looking at late September or early October. Please indicate in your application if you will be available to travel during this period.

If you are interested in participating, please send us an email to contact@pfsnetwork.org. Again, please do not send a PM. We will then be working to finalise the most suitable patients.

Thank you all for your continued support & bravery.

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Not sure if this information already been sent out, but how many participants / samples are you looking for?

Either way I will 100% apply.

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Great point, I should have mentioned.

We’re looking for 25 participants.

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are over 40s too old?

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Not necessarily, depending on how they meet the other criteria.

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I will apply as well, I was wondering do you also get to see the results from your own sample once the research is done?

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If I’m over 50, and had PFS for over 15 years, can I submit a sample too?

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I’m 60yo care level 3 with a supervisor since I have PFS. Can’t speak out can’t organize anything.

But what about the idea to fundraise money to support young “one pill fully blown pfs victims” from far away to make the journey to Hamburg to collect 25 of the best samples in the best timeframe.

I think collecting samples for the Baylor study did years of time.

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It’s great to see this rolling and I really like @Exsexgod’s idea.

Can you provide/remind just on high level, lay terms what the researchers are going to be looking for? Are they going to try to duplicate the Baylor findings as supporting evidence and/or actually test their hypothesis regarding 5-ARI? Do they have a hypothesis of their own?

Three world leading AR gen locus and signaling specialists from prostate cancer research try to determine a pathology. Summary of a comment.

Could it lead to a therapy?

Immediately, no. This is not about testing therapies, but improving our understanding of this condition. But, of course, we want to improve our understanding of the condition in order to be able to determine effective and safe treatment options going forward,

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All research done is intended to eventually lead to therapy. The question of how long it takes to get there comes down to how much each individual in the community is willing to support community efforts

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are you also looking for patients with other syndromes such as PAS / PSSD?

No. This study is limited to PFS patients. We are convinced that PFS, PSSD and PAS are one condition. But it is currently more practical to limit the scope to PFS.

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Lots of questions and enthusiasm. Thank you to all those who have applied over email.

I’ll have to check with the researchers, but I don’t think so. The value of research data is in the aggregate and not the individual, and given they’ll be performing highly complex analysis which likely wouldn’t make sense to most patients, I don’t think there’s much value for the individual patient either.

Researchers have asked us to prioritise patients 35yo and under because that is going to be the age of our sample population. However, please submit an application anyway. If you meet the other criteria mentioned above well, and we get a lack of suitable younger candidates, we may select older patients.

I think that’s a great idea. We’re fielding applications globally but prioritising those in Europe and think we can get enough from EU/UK. But if there are any severe North American patients or from other parts of the globe who can be sponsored, I’d be interested to see what people can contribute.

A full overview of the study can be found here: https://www.pfsnetwork.org/epigenetic-study

Researchers will be looking at:

  • Chromatin structure
  • Methylation in the AR regulatory region

We may also be doing a part II that performs RNA sequencing, but we’re getting this study out the door first.

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Did Baylor provide some of their findings for this new study or do they keep those results behind closed doors because of " ethical reasons" :roll_eyes: just curious

The overview says it’s building on Baylor but I would assume the first step then would be to confirm they see the same gene expression changes in the new samples that Baylor saw in theirs.

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Baylor identified WHAT genes were differentially-expressed.

This studies appears to be geared toward figuring out WHY those genes are differentially-expressed.

In this study, researchers will use state-of-the-art high throughput sequencing to investigate potential changes in the spatial organisation of chromatin. Chromatin structure is a key component in gene expression, and identifying changes could provide key insights into the pathological drivers underlying altered gene expression in Post-Finasteride Syndrome.

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