To those of you who are considering drug trials, my advice is to be prepared for ups and downs. My husband is being screened for a Phase 1 trial at the Royal Marsden, UK. So far various overnight trips (at our cost until he get on a trial at which point they contribute to travel cost) included some for just chats about the 'no guarantee' in trials talk. Then some blood works. The latest visit included a set of scans, more blood works etc. Just as you think that you are almost qualifying something else is there to be done. There is a lot of uncertainty and it all has to be done within a given number of weeks to qualify. If you decide to go for it, you have to have a very accepting attitude to changes and uncertainties. Otherwise, the experience is quite stressful. If everything including bloods are okay, there will be a biopsy. It is a long and slow process and the clearing of hurdles is a thing that is difficult. In our case there is a long drive to the hospital and a stay away overnight which makes it more tiring. We are keeping fingers crossed to qualify and then to have an effective response without nasty side effects. My husband is keen to try to be on a trial if he can. I had not anticipated the psychological stress of the qualifying process at the screenings or the inefficiency of it all (we have given his disease history to different members of the team several times) - all I did was to drive, and wait around the lobbies and at an over-crowded cafe; he had to be in and out of various machines and be poked and prodded.
My husband is allowed to undergo a radiation treatment to his painful hip as the planned biopsy will be from a lymph node that has been spotted as active. If he gets on a trial, all medication will have to be cleared with the trial team. Quite a process. We are hoping that it will be worth the efforts.
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spw1
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Than after all that scans you can just say goodbye to them and find a phase Ii clinical trial or maybe even another phase I clinical trial which is a combination of 2 approved procedures like for example (you may not qualify) of taking Nubeqa and SBRT your on the PSMA PET scan visible mets not visible on the nuclear medicine bone scan. Etc
It is just an example of a phase I clinical trial which would be of interest to me instead of a dangerouse toxicity evolution phase I clinical trial.
Are you familiar with all the clinical trials in UK? Is there anything what would be of interest for you?
Yes after all the scans and results next week they could just tell us that he doesn't qualify. We are hoping that the may say instead out of 50 odd trials we have, try this or that. So far they have not given us that message. I have made a list of a few possibilities. Quick rising PSA is hurdle for us. Was 600+ on 7 Sept and 1200 yesterday.
Thanks for the info - good to know what is involved. Which trial is it? Also thanks for volunteering for a trial - it's due to brave people like your husband and yourself that we have advances in treatments. I wish you both well. From L. In Nottingham UK.
What is difficult is that nobody fights your corner from the medical system. Each of these requires MO's cooperation to send history and referral to and he is reluctant to do more than one at a time. You would think that people like the Marsden hospital will look at totality of one patient and do the best for that one. We assume that they suggested the screening that they did for a good reason. We have to have faith.
Regarding their not offering the best possible treatment, we have to remember that clinical trials are not about giving the best treatment. They are paid for by a drug company or other company trying to get some potentially big money-making drug/procedure approved. We have to research in advance to see if the trial procedure or drug is likely to benefit us before signing up. Potentially you might get a great and life saving treatment, but their purpose is not to tailor a treatment to the patient. Good luck in your search for the right treatment.
I do not see why one cannot choose the best trial for the patient. They have many trials ongoing - it can be a situation to benefit both unless one is going for a randomised trial. This is Phase 1 stuff.
I am not eligible plus I didn't reasearch that clinical trial fully, i was thinking to call them and clerify couple of questions with them.
I believe that I am not eligible as I don't have even a single metastasis visible on the PSMA PET scan now.
It may change however.
I was considering SBRT with the MRI Linac and came out during the conversation with the RO that they may don't give that for the clinical trial participants.
I really didn't go deeply into all the details of the trial as I believe that I am not eligible anyhow.
In the back of the mind I wish to call them and find out if they would maybe take me and what would I get from them.
hmm this trial may need PSMA avidity I think. But surprisingly they are not doing an FDG scan for concordance. Not all eligibility criteria are published ahead. We only discovered the ones about blood tests etc once we embarked on this journey.
The trial is about Nubeqa. Bayer is financing the trial.
They would give you Nubeqa plus they would radiate your on the PSMA PET scan visible mets. You should not have any mets visible on the conventional CT and nuclear medicine bone scan.
FDG PET scan is not needed. It is not about Lutetium PSMA therapy. Only a new phase I clinical trial with Nubeqa and they would radiate your mets.
I believe all the inclusion and exclusion criterias should be listed but I couldn't even understand if they would also radiate your prostate or just the mets.
I agree with you that medics are not very exact. In other parts of our life we have more defined rules.
There are many trials going on and the UK link does not open the US ones also being tested here. It is a lot of going through the list but I chose the ones that my husband will qualify for. Spine mets are a contraindication in a few and since the chemo failed, he has developed these.
We certainly hope so. It will be a discussion to be had if there is pain. They have already indicated that the RT to mets is possible when there is pain.
They promised a biopsy soon at our first meeting on 19 Aug. Medics do not move in the same way as one would in other fields. They also said that being invasive, they will only do it last minute if we qualify otherwise. They are not a treatment hospital and so have no duty to do general checks for possibilities. Our local hospital is cash strapped to offer anything as fancy as a biopsy of a tumour.
It is understandable. They chose the one they think is appropriate and in mid Aug when we first saw them, the blood works were a lot better and PSA was 99. The process is slow and needs one to have gone through some pre requisite hoops (in our case doing more chemo although it was known to be ineffective).
Currently eligible if at next test, the bloodmarkers meet the criteria and the PSMA report when it is available is positive. It may be that the biopsy will need something to meet the requirements. Bit of an uncertain time.
Thank you. What surprised me was that when we came to the end of SOC offers, the MO or the RO did not volunteer anything about the trials. We have been proactive from before SOC options ended. Since 19 August, to yesterday, all our visits to the Marsden have been about getting to this point where a trial appears close enough and yet we are not sure we have got onto it. Best wishes to you.
Thanks for the great post on the emotional toll of a clinical trial. It is a huge undertaking administratively, for doctors, staff, ethicists, and for the patient. Patients are very closely watched - and you are pointing out the repetitiveness and inconvenience involved in that. In fact, because of the intensive observation, some researchers have pointed out that all patients do better on clinical trials compared to real-life results in community practice.
Royal Marsden is among the best institutions in the world, and Johan DeBono is world-renowned. Their lab results (the Attard Lab) are widely cited, so all those blood and tissue samples are valuable. Hopefully, your husband is helping himself, but he is also helping many others.
Indeed. There is a large team there and the prof himself (we saw him a few times) v caring. The nurses were compassionate but my husband has to (and any other guys going on the trial have to) be prepared for the ups and downs and near misses. Once he is on the trial, he will have more monitoring than ever before in his treatment. The trial is described as Potentia or Crescendo (see above in my replies the link).
I've known several men who tried BiTE (this is tri-specific, which is similar). It is both promising and scary, as is any treatment that takes the brakes off of the immune response. Please let us know how it goes.
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