Archive for the ‘Galeterone (Tokai TOK-001)’ Category

It’s been five months since I have made any regular visits to Las Vegas, and oddly enough, I’ve kinda missed it. But I’m gearing up for a new clinical trial and getting back on the road to my cancer treatment home away from home.

It’s just not easy to explain briefly how my health has been, but I’ll try. Last August I started my fourth treatment, third clinical trial, with Dr V. ┬áIt combined Taxotere (a standard chemotherapy) with Lenalidomide. The chemo lasted until December (they actually pulled the Lenalidomide after a couple of months when they found no benefit in early trial data).

So starting mid-December, I was off chemo and had no new clinical trials ready to go. We decided to start with Zytiga (abiraterone acetate), a new drug that had been approved by the FDA in April 2011. Since there was no study protocol, I began seeing a new oncologist in Salt Lake who could monitor lab work and give me monthly injections of Xgeva (denosumab), a bone-repair treatment that was FDA-approved in November 2010.

Somewhat surprisingly, I had good results for four months on Zytiga. It was surprising because my first clinical trial (Tokai’s TOK-001) was a drug that is quite similar to Zytiga. It seemed likely that my cancer might have already learned from that one how to get around this particular drug, which inhibits the CYP17 enzyme that is “required for androgen biosynthesis” (try reading the official literature on this drug for some real fun). Essentially it blocks anything, prostate cancer cells included, that tries to build androgen hormones. I like to think of it as an intense hormone blocker that has turned me into a soft blob of a human being. Something between the Michelin man and Mr. Bill. And then add on white curly hair from my chemo-perm. I don’t look like myself, lately.

The thing is, Zytiga worked for me, probably because I had been on a fairly low dose of the Tokai drug. In December, my last CT & bone scans showed that I had somewhat extensive bone involvement with my cancer, in spite of the chemo; my PSA was in the 300 range. Since then we’ve only really checked PSA levels, and they dropped as low as 97 before rising a little (112) and then jumping up higher (186). So, it looks like there are cancer cells that have found a new way to survive.

For whatever reason, I’ve had to deal with extensive pain since the beginning of the year. Honestly, I don’t know what’s intensifying the pain. I assume it’s tumor activity in bones, but with my PSA dropping while the pain increases, that doesn’t seem to tell the whole story. It could be that Zytiga is part of the problem, since known side effects include joint swelling and pain, and muscle discomfort. The pain could be related to Xgeva which, like Zometa, can induce muscle pain and flu-like symptoms. Of course, no drug company wants to take responsibility for my pain, and with multiple things going on, there’s rarely a clear answer.

Happily, we’ve got a new clinical trial now that my PSA is rising. Bayer has partnered with a Norwegian company, Algeta, that developed a treatment called Alpharadin. It uses a form of radium-223 to deliver low-intensity radiation directly to cancer cells. It’s a smart idea that has improved on similar drugs like Samarium-153, which has been used since 1998 for pain management of bone metastases. Alpharadin is on track for FDA approval, and the best thing is that Bayer has opened up their phase III trial for compassionate use. This means that if you qualify, they’ll let you in on the trial so you don’t have to wait for the FDA to grant their magic stamp of approval.

So, I’ve got the paperwork done and it’s looking like I can start within a few weeks. I had a quick visit at the end of April with the doctor, and yesterday I saw the clinic’s radiation oncologist for a review of my treatment history to get everything OK’d. Now we just have to wait for the radium to be delivered from some secret location in Norway

So, Las Vegas, I’m coming back. Be good to me, OK?


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Finished with the first 3 months of my clinical trial. Maybe 15 men with prostate cancer have tried the drug, and it looks promising. Since we are in a phase 1/2 trial, the longer and more important phase 3 is yet to come. I hope that all goes well for this little pharmaceutical company and their new treatment.

To be approved for another 3 months (yes, I was approved), I had to undergo a bone scan and CT scan to monitor tumor growth (or lack thereof). As we discussed the results with Dr. V, Dorothy and I had to expand our understanding of what cancer is all about. The truth is, no single lab test or scan can tell us fully what is going on with my tumors.

First, I’m on a monthly dose of Zometa (zoledronic acid), which prevents bones from losing mass too quickly. Because of that, my bones look different on a CT scan, more dense than might be expected. Second, there can be healing of previous bone lesions from the Zometa. If bones lose density (as they do when you’re on hormonal therapy), tumor cells can settle in and then create lesions, which also reduce bone mass. But those lesions can heal over if all the medications are working, so there are bone spots that show up on a CT scan which could be new lesions or could be healed lesions.

Third, the bone scan is not just about cancer. For that scan I’m injected with a radioactive tracer that flows through my bloodstream and settles into any areas of bone injury, which can be from a previous break that healed or current cancerous lesion, or even arthritis or an infection. This scan is dependent on blood flow to the bone, so it doesn’t automatically find every instance of cancer (if a bone has poor blood flow around it the tracer won’t get to it). When they take a picture after a few hours, most of the tracer is in the bladder waiting to be washed out, and if any areas in the bones have picked it up, those will light up as well. But those hot areas indicate rapid bone growth or repair, which may or may not be from cancer.

Fourth, the bone scan and CT scan have to be compared to see whether spots on either show up on the other, and then the radiologist has to make a best guess as to which spots are active lesions. But even those results are not definitive, because the oncologist can then compare those with PSA trends, bone pain, and so on, and may decide that some scan results are not concerning (as they say). There are many factors that need to be considered, none of which tell the whole story. It helps that Dr. V is getting all the information he can. He has been monitoring testosterone levels (they’re way, way low) and has done three circulating tumor cell tests, which has come back at zero every time. Which sounds really good, but it may just be a limitation of that particular test. Maybe good, maybe not.

So, in a nutshell (a pretty big nutshell): my PSA has dropped a little, bounced up and down, but hasn’t gone higher than the initial baseline. My pain/discomfort in bones and nerves has disappeared, although muscle and joint pain from Zometa are still very annoying. The most recent scans appear to indicate that there is still substantial activity in the sacrum (tailbone), a possible new lesion on the clavicle (collarbone), and possibly still an active lesion on the L5 vertebra. Oh, and one enlarged lymph node in the chest is about the same size as it was three months ago. So, yes, it’s mostly, probably, good news, but good news that requires a broader perspective than simply looking for new lesions or PSA going up.

In other words, I’m not really any worse, possibly a little better. I like to think that it’s been three months without substantial disease progression, and that’s three months of my life that is a gift. Here’s hoping for three more.

After all that technical talk, something simpler.

[borrowed from Magnolias forever]


. . .

Cancer is a white orchid.

. . .

(A mystery quote from a future post.)

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