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