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Clinical Trials, My New Journey

User
Posted 19 Jul 2018 at 21:33

I had my eighth (and last) cycle of Cabazataxel last week. Cut short from the planned 10 cycles as it has stopped working. Saw oncologist yesterday and who has ordered up new CT and bone scans. PSA is 64 with a 6 week doubling rate. 

Met with the clinical trials consultant today and was informed that unfortunately, my tissue sample which had been sent off to Germany has come back negative for a specific gene deficiency they were looking for so unable to get on this particular trial. Apparently 1 in 4 people have this defect so if successful could potentially help about 10,000 men every year. 

I was told however, that the trial will be opening up at a later stage to a wider range of men with different DNA anomalies. 

If interested, here are some links for the trial. 

https://ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialNumber=NCT03188965

https://clinicaltrials.gov/ct2/show/NCT03188965

 

So, I have been offered the chance to participate in a different trial. Once again a stage 1/2 trial., my tissue samples need to be sent off for analysis. This time to America - My tissue samples are better travelled than me at the moment! This will take about three weeks. This would work out great as they need a minimum 28 day "wash out" period after my last chemo before starting on the trial. 

Another benefit is that this time, instead of just looking for a specific genetic faulty, my entire DNA is going to be mapped out and participation in this trial is conditional on a lot more different sorts of defects so there is a greater possibility I may have some of these. It also means that with my DNA sequenced, if I am unsuccessful again, any new up and coming drug will get accurately matched up with me with greater certainty. 

I was told people are paying about £5000 to have this DNA test done privately, so it is a bit of a win win for me.

Here are some links for this trial

https://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=35692

https://clinicaltrials.gov/ct2/show/NCT02797964

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-sra737-for-advanced-cancer#undefined

This trial is not randomised (so I know 100% I get it) and the dosage is now known and some - not all-of the side effects are being seen, which is nausea and diarrhoea.

So now, I have another three week wait when in the mean time I will be getting my scans. Plus, every day passing is another day further from the chemo and the opportunity to get a bit stronger.

Best regards 

 

 

User
Posted 19 Jul 2018 at 21:33

I had my eighth (and last) cycle of Cabazataxel last week. Cut short from the planned 10 cycles as it has stopped working. Saw oncologist yesterday and who has ordered up new CT and bone scans. PSA is 64 with a 6 week doubling rate. 

Met with the clinical trials consultant today and was informed that unfortunately, my tissue sample which had been sent off to Germany has come back negative for a specific gene deficiency they were looking for so unable to get on this particular trial. Apparently 1 in 4 people have this defect so if successful could potentially help about 10,000 men every year. 

I was told however, that the trial will be opening up at a later stage to a wider range of men with different DNA anomalies. 

If interested, here are some links for the trial. 

https://ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialNumber=NCT03188965

https://clinicaltrials.gov/ct2/show/NCT03188965

 

So, I have been offered the chance to participate in a different trial. Once again a stage 1/2 trial., my tissue samples need to be sent off for analysis. This time to America - My tissue samples are better travelled than me at the moment! This will take about three weeks. This would work out great as they need a minimum 28 day "wash out" period after my last chemo before starting on the trial. 

Another benefit is that this time, instead of just looking for a specific genetic faulty, my entire DNA is going to be mapped out and participation in this trial is conditional on a lot more different sorts of defects so there is a greater possibility I may have some of these. It also means that with my DNA sequenced, if I am unsuccessful again, any new up and coming drug will get accurately matched up with me with greater certainty. 

I was told people are paying about £5000 to have this DNA test done privately, so it is a bit of a win win for me.

Here are some links for this trial

https://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=35692

https://clinicaltrials.gov/ct2/show/NCT02797964

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-sra737-for-advanced-cancer#undefined

This trial is not randomised (so I know 100% I get it) and the dosage is now known and some - not all-of the side effects are being seen, which is nausea and diarrhoea.

So now, I have another three week wait when in the mean time I will be getting my scans. Plus, every day passing is another day further from the chemo and the opportunity to get a bit stronger.

Best regards 

 

 

User
Posted 01 Sep 2018 at 00:20
I am sorry that I was away when you started this thread and didn't comment. Fantastic though that a) you have been accepted in principle for the trial and b) that you are prepared to give so much time to it ... not everyone would do what you are doing.

It will be fascinating to see your updates as you go along. Good luck with the final scans & ECG!

"Life can only be understood backwards; but it must be lived forwards." Soren Kierkegaard

User
Posted 03 Oct 2018 at 19:20

That's "T - 7" completed. Had a single dose of SRA737 on Monday. Left home at 07.00am and got home 10.30pm. Was not the walk in the park I had hoped for. You cannot have any food 2 hours before  and 1 hour after. The dose itself was five capsules amounting to 500mg. The dosage is still being finalised so may change. 

After taking them, after about an hour I was feeling a little "queezy". I was provided with some toast and coffee. Immediately after finishing the toast I threw up quite badly. Luckily I was in a side room and made it to the sink (just)! Apparently it was expected and next time I get it I will have anti-sickness tablets to prevent the nausea. Once I had been sick, I felt OK. Whether it was the drug, or nerves or a combination of both I don't know.

Bloods taken before, then hourly, 2 hourly 4 hourly etc. as well as blood pressure and temperature. I was very well looked after. 

Follow up visit 24 and 48 hours for more blood. 

Cycle 1 day1 starts on Monday, with chemo (Gemcitabine) with SRA737 on the following two days. 

So my update next week will be interesting!

Best regards

 

 

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User
Posted 20 Jul 2018 at 17:02
That sounds like an exciting proposition Orm123.

I hope you can benefit from the trial

We can't control the winds - but we can adjust our sails
User
Posted 31 Aug 2018 at 22:17

Well, it's been a long Summer waiting for the phone to ring with any news on new test results. As I said, my chemo was stopped after 8 cycles from the 10 planned as my PSA was rapidly rising.

I forgot to cancel my PSA blood test the day before my 9th cycle so went ahead and had it done. It showed my doubling time had increased to every three weeks (from 6 weeks) and was 127. Not good. 

Whoo-Hoo! was called into the clinical trials department where they confirmed I am eligible for the SRA737 trial. Some links are above or just google it. 

It is a stage 1 trial but they now roughly know the dosage. Some of the side effects are becoming apparent which is fatigue, sickness and diahorrea. It works by blocking the signal to the body which causes cells to grow abnormally. 

The trial is very strictly controlled, weekly attendance in hospital, a full 12 hour day in hospital every 28 days, CT and bone scans every 42 days etc. I need to have the scans done before starting, together with an ECG to make sure I am fit enough so think maybe 3 weeks before it starts in earnest. 

Because of the frequency of attending the hospital, the drug company pays for a taxi to take me and bring me back. Initially they are looking for about 40 people worldwide over 6 different cancers, including Prostate Cancer, so feel quite lucky. However the caveat is they keep stressing it may not work. Since all the mainstream treatments didn't either then I will take my chances. 

I have been told that I will continue to receive the drug as long as I am benefiting from it. Even if at the end of the day it is successful but NICE won't fund it. 

Interestingly on the test results which was a full DNA mapping of my genomes, the ones they expected to find abnormal were not. Only 4 genes were slightly off with marginally incomplete sequencing. Of the 4, 2 are of particular interest (apparently)!

So, I am looking forward to getting started to see where this can lead to. I will keep you updated as to how I get along.

User
Posted 01 Sep 2018 at 00:20
I am sorry that I was away when you started this thread and didn't comment. Fantastic though that a) you have been accepted in principle for the trial and b) that you are prepared to give so much time to it ... not everyone would do what you are doing.

It will be fascinating to see your updates as you go along. Good luck with the final scans & ECG!

"Life can only be understood backwards; but it must be lived forwards." Soren Kierkegaard

User
Posted 01 Sep 2018 at 10:59
This looks like a very interesting treatment. Good luck from a fellow trialler!
User
Posted 01 Sep 2018 at 12:32

Good luck with the trial. I will look out for your updates.

Ian

User
Posted 01 Sep 2018 at 23:08

Good luck with the trial. I hope your route to starting is not as tortuous as mine has been on Re-AKT. But I got there in the end and so will you.

I will also look forward to your updates.

Best wishes

Peter

User
Posted 02 Sep 2018 at 01:25

Fantastic ..good luck. Really interested to follow your thread.

 

thank you for sharing

Clare

User
Posted 02 Sep 2018 at 08:13
Good luck and Thank you for sharing this with us .will definitely be following your progress.All the very best Geoff
User
Posted 11 Sep 2018 at 21:39

Good news. 

I had a bone scan, echo cardiogram, an ECG and loads of blood tests last week, together with a CT scan, another ECG and more blood tests today, and have been told everything is OK to proceed next Monday for "T-7" where I get a single dose of the drug and am closely monitored for a 14 hour period. I get my blood tested half hourly for two hours, then hourly, then every two hours etc. All vitals are also monitored, blood pressure, temperature as well. 

Everything is now in place so any progress is measurable.

All being well, then I start in earnest a week later.  Will get to know what my "starting" PSA number is. Weekly hospital visits with a long day the same as next Monday, every 28 days. CT and bone scans every 42 days.

Nausea and diarrhea  are the known side effects up to now. As this is the first humanised trial of the drug they don't really know much more beyond this, which is the point of the phase 1 trial.

If you are interested, I found some great downloadable PDF's from the drug companies web site which graphically illustrates the science behind the drug and how it should work. http://investor.sierraoncology.com/publications 

I will let you know how everything went next week.

Best regards

User
Posted 11 Sep 2018 at 22:05
Good luck :-)
"Life can only be understood backwards; but it must be lived forwards." Soren Kierkegaard

User
Posted 11 Sep 2018 at 23:40
All the best with this trial

Fingers crossed ..it’s so great that you are doing this.

Keep us in the loop won’t you

Clare

User
Posted 12 Sep 2018 at 07:17
Good luck and thankyou .

Debby

User
Posted 12 Sep 2018 at 18:08

Orm, I sent you a PM and wish you the best of luck, you are breaking new ground. Hope the trials work and get them to pick up the tab for some good meals. If you are allowed, keep us updated with progress.

Fresh

Base jumping without a parachute should be frowned at, never criticised. Fresh

User
Posted 14 Sep 2018 at 21:01

Wow! was thrown a curved ball yesterday! 

I received a phone call from the clinical trials unit that upon analysing the blood taken on Tuesday, I do not have enough of the defective gene (called PIKC3A) floating in my blood and they cannot be certain they would be able to be certain of locating any for the purposes of the trial of the drug SRA737 and the American drug company has stopped me getting on that trial. 

However, I had a meeting with them this morning and I am, however, eligible for another arm of the trial drug SRA737, which is taken in combination with a chemo drug called Gemcitabine. This is an established chemo drug used for ovarian, bladder and pancreas cancers. 

Looking at one of the PDF's downloaded from the link I posted previously, in trials on mice, "lethality" (did not know that was even a proper word) on the cancer cells was>70%

Taken directly from the handout I have been given it states

"SRA737 is a type of drug called a kinase inhibitor. It blocks a chemical messenger (enzyme) called checkpoint kinase (Chk1), a serine-threonine kinase enzyme, which is part of the signalling process within cells which can make cells produce chemicals that trigger and control cell growth and cell death. Chemotherapy agents are used to try and kill cancer cells however some cancer cells can repair themselves using these signalling processes and continue to grow. It is thought that the chemotherapy may help SRA737 to work better by preventing cancer cells from repairing themselves, so that more cancer cells will be killed"

So, in lay-mans terms, the cancer cells will be hit with a double whammy! In every instance with the chemo I have had, Doxetaxel, Enzalutimide and Cabazitaxel, the first few cycles looked good with my PSA plummeting, but then it slowly started to rise as the cancer fought back even more aggressively. This duel combination might just be the answer. 

The way the drugs get given is not what I had expected. First, "T - 7" which is 7 days before the treatment starts in earnest is the same as the last post, a full 14 hour day at the hospital taking a single dose of SRA737. That starts on 1st October

Seven days later I get the chemo on the Monday and SRA737 on Tuesday and Wednesday. This goes on for three weeks with week four completely drug free. Then it starts again. 

The dosage of the chemo, Gemcitabine is lower than the standard dose ( although they could not tell me at this stage how much lower) and the infusion only takes 30 minutes, so half of what I have been used to. Apparently it is well tolerated but I might feel some flu like symptoms for one or two days after the infusion. 

Fortunately, my CT and bone scans will still be under the 28 day limit so I will not need anymore before everything kicks off, albeit two weeks later than planned. On the down side, my PSA which was 127 is now 267 (EEK!) and will be well over 500 at the point of starting the trial. All I can do is to continue what I am already doing, eating healthily and walking my 10-15 miles every day! I cannot tell you the last time I was as fit as I am now!

Once again, I will let you know how everything is progressing

Best regards

User
Posted 14 Sep 2018 at 21:24
Good luck
"Life can only be understood backwards; but it must be lived forwards." Soren Kierkegaard

User
Posted 14 Sep 2018 at 22:12
Best wishes and good luck

Debby

User
Posted 15 Sep 2018 at 10:00

Good luck with this. All of the research you’ve done just shows how complex and multifaceted cancer is. I hate it!

Ian

User
Posted 15 Sep 2018 at 10:21
Sending my best wishes and hope this one goes ahead. What I am finding exciting is that there are so many different trials going on now that must mean there is more hope of finding something that works.
User
Posted 15 Sep 2018 at 11:54
Best of luck with the treatments. Stay strong

Keep the Faith

J.

User
Posted 15 Sep 2018 at 13:56
I can add some thoughts on Gemcitabine because I have used it twice. Both times it was in combination with Cisplatin (the active component of which, so far as PCa is concerned, is said to be Platinum). In my case I had four cycles six years ago for bladder cancer and I am in my sixth and final cycle for a rather nasty and unexpected BC met in my liver and in the tissue which attaches the.bowel to the spine. Now, I noticed six years ago that the Gemcis (as the combination was then called) halved my PSA reading which was very low (less than one). Later research confirmed that the Platinum element is effective in some cases in dealing with PCa, as my oncologist recently confirmed. So far so good, in my case. In addition to a marked radiological response after my third cycle on the liver met, my PSA has downshifted well. From 6.4 pre-chemo, it reached 0.9 last week, after five cycles. Was it just the Platinum element doing this? I don't think so. I'm not even sure that it was the Platinum.

II believe my only PCa met (or maybe remains of the mother ship) is in my urethra. It oozes a discharge out of my penis as the chemo works. Now, it has been my practice to encourage the discharge out of the pipe every morning, as it can be a bit corrosive on the foreskin and to minimise the slight soiling of my pants. I have noticed that after the eighth day of the cycle, when I have a second shot of the Gemcitabine (the first is given after the more toxic Cisplatin on day one of the cycle), the discharge is greater.

My conclusion: Gemcitabine is effective against PCa, at least in my case. As it is so much easier to handle in terms of side effects, I wonder why it has not been tried before, but I am very glad to see it used in this trial. I would be hopeful of it bringing results, as I am sure it is for me. In fact, I am tempted to ask my oncologist to give me continued treatment (off label, I suppose) with Gemcitabine alone to see if I can get the PSA below 0.1, eventually....

AC

User
Posted 22 Sep 2018 at 21:51

Hi AC,

I think you are absolutely correct. See the link from the drug companies web site.

https://www.sierraoncology.com/development/sra737/targeting-chk1/

The graphics are great and gives you a clear understanding of the science behind it all.

So, bloods and screening on Tuesday, single dose  of SRA737 following Monday, then it all kicks off with Gemcitabine a week after that with SRA737 the following two days.

Best regards

User
Posted 03 Oct 2018 at 19:20

That's "T - 7" completed. Had a single dose of SRA737 on Monday. Left home at 07.00am and got home 10.30pm. Was not the walk in the park I had hoped for. You cannot have any food 2 hours before  and 1 hour after. The dose itself was five capsules amounting to 500mg. The dosage is still being finalised so may change. 

After taking them, after about an hour I was feeling a little "queezy". I was provided with some toast and coffee. Immediately after finishing the toast I threw up quite badly. Luckily I was in a side room and made it to the sink (just)! Apparently it was expected and next time I get it I will have anti-sickness tablets to prevent the nausea. Once I had been sick, I felt OK. Whether it was the drug, or nerves or a combination of both I don't know.

Bloods taken before, then hourly, 2 hourly 4 hourly etc. as well as blood pressure and temperature. I was very well looked after. 

Follow up visit 24 and 48 hours for more blood. 

Cycle 1 day1 starts on Monday, with chemo (Gemcitabine) with SRA737 on the following two days. 

So my update next week will be interesting!

Best regards

 

 

User
Posted 11 Oct 2018 at 20:31

This week started the trial proper. 

As chemo was on Monday, blood had to be taken and tested before getting the Gemcitabine. The starting PSA figure is not very good, 465

Cycle 1 day 1 is the chemo, apparently about 50% of normal dose, infusion 30 minutes. Needed to stay for bloods 6 hours after having the chemo

Cycle 1 day 2 was the first dose of SRA737. Unlike previous week, had anti-sickness tablets so (fortunately) kept it down. 5 x 100mg capsules. Needed to stay for 4 hours for bloods. 

Cycle 1 day 3 same as previous day

I am very impressed at the attention to detail the trials team go into. Nothing is overlooked. I feel in very safe hands. The amount of blood taken though would make Bram Stoker proud!

Overall impressions is that this is do-able but no walk in the park. It is funny how you easily forget how much chemo and other treatments mess with your overall health. I am now back to plodding along instead of walking spritely. It has been a few months since last finishing the Cabazitaxel that I have felt so exhausted. 

Still, 4 days off until next chemo which will be Cycle 1 day 8. Happy days!

Best regards

User
Posted 11 Oct 2018 at 21:07
Stay strong Orm, we re all wishing you well.

Keep the Faith

J.

User
Posted 18 Oct 2018 at 19:48

2nd week of cycle 1.

Monday. Chemo was almost delayed as my white blood cell count was a fraction over 1. However I did receive the infusion. It is seven days after last chemo so was expecting something like this. It is normal for an "isolation " period. I was told that the dose of the chemo was greater than given to the few previous recipients as the exact amount of chemo is still being analysed. 

Tuesday Got to take the SRA737 at home which was great. Felt very nauseous though

Wednesday. Long day at the hospital (7.00am to 10.00pm) Took the drug and had blood taken at the usual intervals throughout the day. Good new was my white blood cell count had risen to 2.5!

So that is it until chemo on Monday

 

Best regards

 

 
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