You will find short stories on this site. Most are autobiographical. Some are fiction.

CLINICAL TRIAL

Introduction:

Have you ever considered volunteering for a clinical trial? I considered it for a year and eventually decided to do it. This is the story of the experience and consequence of being a participant in the trial of a drug that was thought to reduce the incidence of prostate cancer. The drug is named Finasteride. The trial was a randomized division of subjects into two groups. One is taking Finasteride the other a pill which looks exactly like the real thing but is a fake, a placebo. The study was “double blind”, meaning neither the medical team nor the patient knew which group they were in. The study began enrolling volunteer subjects in 1994.

Incentive to participate:

I first heard about the prostate cancer (PC) prevention trial in 1995. Recognizing how prevalent and dangerous this disease is among men, it seemed like a wonderful prospect that a prevention was possible. Being 57 at the time, I was the right age to participate. While there is no history of prostate cancer in my family, there were reasons that I should volunteer. If, in the random selection, I was placed in the Finasteride group and if it was shown to be beneficial, I could reduce my chances of developing prostate cancer. Regardless of my group, or the study’s outcome, it was certain that this study would be beneficial for all men, including my two sons, as it was certain to provide a step forward in the search for a means of reducing prostate cancer. It took several months for me to decide to volunteer.

The experience of being in a clinical trial:

When I did, I contacted the research coordinator on the research side of Kaiser Permanente. Mary Wang was a pleasant and engaging woman who explained the commitments I would need to make in order to participate.

1. I would take a pill every day for seven years.

2. Mary would call me every three months for a telephone interview.

3. There would be a medical exam every year. The primary purpose of the exam was to draw a blood specimen and to have a digital rectal exam of my prostate.

4. At the end of the seventh year, I must commit to having a prostate biopsy.

I agreed to these conditions and signed up to take the little white pills every day for seven years. Had I known more about the discomfort of having a digital rectal exam and the pain of having a prostate biopsy, I would not have gone ahead with it.

Adding a pill to my morning vitamins was no bother at all. The quarterly phone calls from Mary became a pleasant routine. She never failed to express gratitude for my continued participation in the study. It felt good to know that my participation, along with that of 18,881 other men, could lead to a means by which men, in the future, could be free from suffering and dying of prostate cancer.

The stress involved in anticipating and receiving the annual digital rectal exam is more a matter of loss of one’s dignity than actual discomfort. I never thought much about my dignity until I was bent over an exam table and had a doctor shoving his finger up far enough to feel for bumps or graininess in my prostate through the thin membrane of my rectum. There is some pain also, especially when the doctor has large fingers as mine did.

Early termination of the trial:

It had been six years since I enrolled in the trial. I was driving to work and listening to Morning Edition on NPR when the moderator said something like ‘A major clinical trial concerning prostate cancer prevention has been halted early due to finding elevated levels of high-grade cancer among those receiving the medication.’ The story did not specifically identify the trial in which I was a participant, so I continued with my daily pills. A couple of weeks later Mary called to tell me that the trial had been terminated. She pointed out that since the trial was not completed, I was no longer under the obligation to have a biopsy. However, she continued, “You have stuck it out this far, it is very important to the study that you follow through and complete your participation by having one.” I acceded, not wanting to quit before the trial could benefit from my participation. I also saw it as a way to confirm my belief that I was free of prostate cancer.

The discomfort of rectal exams was nothing compared to the pain of the prostate biopsy. It is performed with device, which I think of as a revolver pistol, with five tiny cylindrical syringes. This gun is inserted into the rectum and one by one these syringes are shot through the rectal membrane into the prostate gland. Each is extracted with a small bit of tissue to be examined under a microscope for the presence of abnormal cells. Some doctors inject an analgesic before this procedure. Mine didn’t. Each of the successive stabs was more painful than the previous one. I consider myself to have a relatively high threshold for pain, still, that biopsy was excruciating.

Personal consequences of the trial:

Approximately a week after the biopsy I was working in my vegetable garden when I received a cell phone call. It was a urologist calling to inform me that the biopsy revealed that I had prostate cancer. He asked me to come in for an explanation of the alternatives for treating it. When my friends learned of this they treated me like I was destined to die soon. I assured them that because of the trial and early detection, I had a good chance of beating the cancer.

At the appointment with the urologist, I was told that there were several options. “The gold standard is surgical removal of the prostate.” But there are other options. Radiation is an alternative that destroys all of the tissue in and around the prostate. Another is cryotherapy, in which metal probes are inserted into the prostate. These freeze and kill the surrounding prostate tissue and the cancer in it. All three of these carry a high probability of damage to nerves and resulting in erectile dysfunction (ED). These procedures may also be likely to result in problems with bladder control. A fourth option is ‘watchful waiting’. This is where the patient has periodic urinalyses to track levels of prostate-specific antigen (PSA). None of the listed treatments are undertaken unless the PSA rises.

My goal was to get the cancer out of my body as quickly as possible. Surgery offered the best opportunity, among the procedures, to avoid the onerous side effects. I trusted that my urologist to do everything possible to spare those important nerves that provide the stimulus leading to erections. I felt fortunate that I had entered the Finasteride trial, if I hadn’t, the cancer in me could have grown, undetected and, become terminal.

Follow-up:

As it turned out those important nerves were damaged during surgery. I was among the unlucky 50% to experience ED. Over the subsequent years several women in whom I had great hopes for a serious love relationship, turned away with the explanation that “It doesn’t work”. One of the most unpleasant aspects of it was the term used to describe my condition, ‘impotent’. A year after the study had been stopped, I received a letter informing me that I had been in the placebo group. Within the year following my surgery, the recommended treatment protocol for low-grade PC, such as I had, was changed to adopt watchful waiting rather than one of the three destructive procedures. Another change which occurred in that year was the use of laparoscopic surgery in which there less chance of damage to those important nerves. Less than a year after my surgery, a friend of mine received a diagnosis like mine, with a Gleason grade of seven. Consistent with the new protocol, he was advised to proceed with watchful waiting. This he has done and continued his life as before including normal romantic affairs. It was my bad luck that I was diagnosed with prostate cancer less than a year before these improvements in approaches to prostate cancer treatment occurred. Had I not volunteered to be in the clinical trial or if I had not agreed to have the final biopsy, it is likely my cancer would not have been detected until after that critical year.

Such conjecture is of no value. I am grateful for the way things turned out. In each of the twenty years since my prostatectomy, I have had a PSA test. Each time I am relieved to learn that the test detected no PSA. I have been able to live these 20 years since the surgery, with increasing confidence that I will continue to be free of prostate cancer.

It has been interesting to observe changes in my feelings toward women since natural intercourse is no longer a possibility. One aspect of this change is that while I still admire beautiful women, my pleasure in seeing or knowing a beautiful woman is an aesthetic experience that no longer involves sexual desire. Appreciating the physical beauty of a woman is now like admiring a beautiful flower. I believe that this freedom from the emotional tension associated with frustrated sexual desire extends to reduced anxiety in general.