Clinical Trials, My New Journey

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.

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

Debby

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

Debby

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

Keep the Faith

J.

Week 3 Cycle 1

Touch and go on Monday. My white blood cells were down to 0.7. As a result my chemo was reduced by 25%. Told to take care to prevent any infections and avoid people with coughs and colds. 

Tuesdays SRA737 saw me vomiting about 2 hours after taking it. Advised to have some breakfast first then nothing for 2 hours after that before taking the drug. 

Wednesday I followed the advise and it seemed to work. 

Still feel a bit queasy though. 

Blood test today (Thursday) saw my white blood cell count up to 2.4. Great!

There is now no more treatment for about 10 days before Day 1 Cycle 2 Looking forward to the forthcoming break from treatment! 

Best regards

Hope all goes well Orm123,

Ian

AC

Cycle (month) 4, Day 1

Trial seems to be going well. I actualy feel quite good! Anti-sickness regime working well. Everything seems stable, PSA marginally up but well within the 10% margin of error. No pain.

Next CT scan on 22nd January and I will get the results following week. 

Fingers crossed for a completely boring 2019!

Happy New Year!

Best regards

Keep the Faith

J.

PSA result from last week showed it completely stable. It is over 400 but was told by consultant not to obsess over it as all of my blood works are good. I do have to admit I feel great though!

It does look that the SRA737/Gemcitabine combo has stopped the clock on any progression which is great. 

As you know, this trial covers 5 different cancers but in a few months a trial specifically for prostate cancer will commence. It is combining the SRA737 with a PARP inhibitor (which prevents cancer cells from repairing themselves) called Naraparib.

Best regards

However, I had my 2 monthly CT scan last week and unfortunately the indication is that a new area of bone in my left hip is showing signs of disease. Took me a bit by suprise as I feel totally pain free and fine. A bone scan has been arranged for Wednesday as the last one I had was back in September. There is a (small) chance that it has always been there and as occurred on my right hip that the bone is healing itself and it is the thickening that is showing up on the CT scan. I will know the verdict next week.

Every treatment I have had to date has shown signs of failure at this period of time.

Everything else is completely stable, my PSA and more importantly, the mets to my lungs. If it is deemed that this is indeed progression, then unfortunately I am off the trial.

I will know next Monday.

Going to be a long week...

Best regards

Fingers crossed for you

Sounds like a success  that you feel great compared to a year ago. Hope the next trial keeps you feeling well and pain free.