Tim B. talks about what it was like to participate in the clinical trial that led to Erleada’s (apalutamide) FDA-approval.
How did you find out you had prostate cancer? How did that journey begin?
Tim B: In 2005, I had a rising PSA. Every year or so, we did a PSA test because the urologist was concerned about my rising PSA. I was over the limit for my age. I had three biopsies. Eventually, they found out I had cancer, which was a Gleason score of 7, a 3+4. Not a whole lot of cores were involved, which was good. I thought that if I changed my diet, I would be able to do active surveillance, so I did. That lasted about nine months. My PSA kept going up.
Finally, I had a radical prostatectomy in 2013 and I had clean margins. There was nothing outside the prostate as far as they could tell. I continued on my healthy diet. I’m into heavy exercise; skiing, swimming, walking, and playing golf.
Unfortunately, about six months later, I had a PSA of 0.03, which meant there was still some cancer left. I was hoping it would die, but it didn’t. My PSA was going up slowly. I waited around until it got to 0.5. Then at 0.5, I decided to do something and talked to my urologist. He told me I should go on hormone therapy and salvage radiation. What a terrible name!
I agree. It’s a terrible name.
Tim B: I really didn’t want to do the standard of care. So, I asked if I could join a clinical trial. I was open. If something were out there that could help me and the world, that’s a pretty cool thing. He told me about a urologist down at UCSF, Dr. Eric Small. I went to the website—and I’m sure other men would experience this— they’ve got all these clinical trials, but I couldn’t figure out which trials I fit into. It’s very confusing. I live in Reno, so my wife and I drove down to San Francisco, and we met with Dr. Small. There was one trial he thought might work, but he needed to see me every month in San Francisco. I said, “If we can do something and get rid of the cancer in some way, I’m willing to drive from Reno to San Francisco once a month to meet with you.” (Over 200 miles away).
Dr Small explained there were three segments to the trial: either I’d get only experimental drug, only hormone therapy, or a combination of the two. He said I could back out of the trial if I found it wasn’t the right thing for me. I was hesitant. The only two classifications I was really interested in were the experimental drug by itself and the experimental drug with hormone therapy. He understood, but encouraged me to sign up. I signed all the papers. It turned out I got only the experimental drug, which was perfect. That began my journey.
Because experimental drugs are experimental, they don’t know the right dosage. They have ideas. They know how it works. But in Phase II, you’re a guinea pig. You’ve got to assume you’re a guinea pig, and some men won’t like that. I figured somebody’s got to do it. It’s a valuable thing for the rest of the men in the world.
My dosage was four pills a day. My PSA was up to 2.0 and the cancer was growing very fast. The doubling time was about two or three months when I started taking the drug. And the drug started working right away. After the first month, my PSA dropped down to 0.03. By the second month, it dropped to undetectable. I thought it was great!
During the third month, I got hives. The hives were so bad, I couldn’t get out of bed. I was the first one in the trial that had gotten hives and rash because I was the first to get the new formulation unknown to me. A number of other men experienced the hives later because, in the midst of the trial, they changed the formulation. But it was only two weeks of agony and pain for me, as they eventually cut back the dosage by a quarter. I also found out, fortunately, that
Southwest Airlines had a really inexpensive flight down to Oakland. I could take the BART around to San Francisco. The flight was $49 each way, which was a no-brainer. It’s less than I spent on driving. I could actually make a roundtrip to San Francisco in one day, and so it became much less expensive.
The whole time I was taking the drug, my PSA stayed undetectable. But then, unfortunately, the trial was over in August 2017. I had to go off the drug. My PSA started going up again, doubling every three or four months. My PSA is now up to over 1.2, and I’ve had to go to the standard of care. I’m on hormone therapy, and I start radiation in May. I avoided the standard of care for two years, which to me was worthwhile. And, I helped get the drug through the FDA.
I loved the drug. I would love it if the FDA approved the drug. Right now, it is approved for a more serious metastasized cancer. But I’m hoping that it becomes available to all men because that would really improve their quality of life.
What would you say to other men who are thinking about a clinical trial?
Tim B: Because this is an experiment, it’s going to be a bumpy road, and you’ve got to be ready for a couple of bumps along the way. Hopefully, you don’t get a rash or anything negative. The nice thing was I knew what drug I was getting.
We decided that we didn’t want to take a chance of being a placebo group, although trials are generally set up so that you can back out. So, if your PSA starts going up, you can get out. I would say, get a good doctor who you can communicate with. I thought Dr. Small was a great doctor to talk and work with. His team was very helpful. Those were benefits. I couldn’t have known beforehand, but the fact that they’re a teaching university that does research helped a lot.
Don’t expect that the trial will solve all your problems. Obviously, here I am two years later going down the path I didn’t want to go down, but I can’t find any other trials that fit me. If there were another trial, I know Dr. Small would tell me about it.
Your urologist becomes another advocate. You need to build your network of people. That’s how I look at Dr. Small, as part of my support network.
You’re a member of Silicon Valley Prostate Cancer Education and Support Group through El Camino Hospital, right?
Tim B: I was. I’m now a member of the Renown prostate support group here in Reno, now. But I stay on the Silicon Valley email list because they send out informative emails, and no matter where you are, you can’t get enough information. I love the fact that new developments are going on to protect men.
Are clinical trials a subject matter that comes up in your Reno support group? Is it something that men are talking about?
Tim B: In my group, they do not presently, but when I was living in Silicon Valley, we did. I’ve done lots of the experimental trials (not FDA approved). I had an inter-rectal MRI once when I was in the Valley. I also had a PSMA PET scan, which showed that I have presently got lesions in my prostate bed.
I know I’ve got cancer, and I’ve got to do something about it. More trials are performed nationwide near teaching universities. Trials are not for everybody, but if you’re willing, the developments are happening so fast that you can’t afford not to be thinking about clinical trials as an opportunity.
Tim B: I’m very excited about the future. I hope that something like Erleada (apalutamide), which was ARN-509, becomes a standard of care. I think that these drugs have the potential to help a lot of men.