My experience with clinical trials

I was a participant in several NCI sponsored clinical trials, one main one to determine the efficacy of MRI guided radiotherapy, and a couple of subsidiary ones that performed biopsies and studied tissue samples pre and post radiation.

Here are some of the things I discovered about clinical trials - at least the ones I was in:

1. The quality of the doctors is very high. The people conducting clinical trials are not just medical practitioners, they're scientists. They were able to cite current scientific literature. They could explain concepts to whatever depth I was able to understand. They were very aware of what they knew and, equally important, what they didn't know. The docs also spent more time with me than most doctors do.

2. The medical testing was exceptionally good. The trial investigators needed to know as much about me as possible in order to determine whether I was really a candidate for the trial and to gain insights after the trial about what worked or didn't work and why. Extensive scans and blood tests were performed.

3. The follow-up was exceptionally good.

4. For my trials, the cost was born entirely by the trial sponsor (the National Cancer Institute). I paid nothing for my examinations, treatment, hospital stay, or follow-up. Even my parking fees were paid.

5. New knowledge was gained and published. In my particular case, the trial was a success but was overtaken by events. MRI guided radiotherapy worked well but improvements in much cheaper x-ray and ultrasound guidance made those cheaper technologies just as good.

I recommend that everyone at least consider participation in clinical trials if there are trials appropriate for their particular situation.

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  • I have been a participant in 3 research studies/trials and continue to consider other opportunities. My primary oncologist keeps on the lookout for trials, and not just locally, and is generous. With his time whether I am currently in a study or not. One of the studies has already been published, one is ongoing looking at circulating tumor cells, and I was pulled from one because of mixed results in terms of more mets.

    Participants must understand that participation is for the greater good, and may not help, and could even make your cancer worse. For me, it's worth the risk.

  • CTCs seem to be an important topic for future progress. Can you say what was the object of the study, where it was, and then anything else....

    oh - it was the liquid biopsy angle. Can we tell the state of the tumor from the state of the circulating tumor cells. Hmm. Maybe. Except that the CTS go to settle down in the bone, and what happens there is probably not reflected in the blood stream. Maybe if you flush some of those out of the bone with stuff they use in stem cell harvesting.

  • The title of the study is Molecular correlates of sensitivity and resistance to therapy in prostate cancer, although the title on clinicaltrials.gov seems a bit different (not just prostate).

    Here are the objectives from the clinical trials site:

    PRIMARY OBJECTIVES:

    I. Obtain tissue through tumor biopsies and/or surgical resection and matched blood samples from patients with localized and metastatic prostate and bladder/urothelial cancer for: mutation mapping using OncoMap and other high throughput genotyping technologies; sequencing of tumor genomic deoxyribonucleic acid (DNA); global assessment of gene expression to generate hypotheses that can be tested in subsequent trials (by gene expression microarrays and/or complementary [c]DNA sequencing; profiling of genes involved in androgen metabolism and DNA repair; quantitating peptides, hormones and other locally-derived or systemic metabolites present in tumor tissues.

    II. Obtain samples from controls, including blood or tissue for comparison with samples noted above.

    SECONDARY OBJECTIVES:

    I. Determine whether levels of other androgen synthetic enzymes predict responses to agents targeting the androgen-androgen receptor (AR) signaling axis.

    II. Determine whether intratumoral androgen levels are increased compared to serum levels, and whether they correlate with androgen synthetic enzyme levels and/or responses to therapy.

    III. Determine whether time to progression on therapy correlates with androgen biosynthetic enzymes or hormone levels.

    IV. Determine whether gene expression profiling can predict response and time to progression for chemotherapy or targeted agents.

    V. Identify immune B and/or T cell markers, sequencing and/or antibodies that may correlate with response, time to progression and/or overall survival for patients undergoing immunotherapy.

    OUTLINE:

    Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.

    I have been in this study since March of 2014, and at one point the research coordinator said I might be in it for as long as 5 years. That sounds good to me at this point!

    It is being conducted at the University of Washington (Seattle Cancer Care Alliance). Clinical trials does not indicate any other locations involved.

    I was also included in another genetic sequencing study funded by Stand Up to Cancer, with the results published during the summer in the New England Journal of Medicine. That study was focused on the BRCA-1 and BRCA-2 mutations (which I do not have).

  • Thanks for the info. I am waiting to see if I qualify for a clinical trail that my oncologist is conducting.

  • Alan, I can not agree more with you. I just participated in a contrast trial for PET/CT at NIH. Isn't that place beyond amazing? The contrast in the trial did not personally yield a positive response, but it is still on going so hopefully for others it will give them more information and the trial will be positive which will then be helpful for the rest of the community. Time will tell.

    After the trial I was invited back to NIH to participate in what they refer to as their Multi-Disciplinary Prostate Clinic where a group of doctors review together all of my tests and treatment protocols since diagnosis and developed specific feedback and recommendations for treatment going forward. Since they recommended that I stay my current course it was very reinforcing. If they had recommended alternative directions that would have given me possible new directions.

    And yes, all of this was on the NIH budget, no insurance issues. I did have do pay for transportation to, food and hotel. However, in my experience it was well worth the expense.

    This trial was my third. I have also been in a trial looking at modalities to moderate hot flashes with ADT and a genetic registry project at Memorial Sloane Kettering examining multi-cancer diagnoses (I have 5 primary cancers).

    Joel

  • I have participated in two trials at the NIH. One with a new imunotherapy drug an another combining docetaxel with cabozantinib. Both trials had some success in slowing my cancer progression. They paid all my travel expenses including flying from Dallas to DC every two to three weeks. Very impressed with the calibar of doctors at the NIH and many are well renowned in their research (Dr. Gulley and Dr Madan were my primary doctors).

  • I wondered if travel and hotel expenses would slow down enrollment in the various trials. Looks like some people have thought the same and planned for it.

  • Alan - where did you do your clinical trials ?

  • It was at the National Cancer Institute's Clinical Center in Bethesda, Maryland. I was working at NCI as a computer programmer. When I was diagnosed with prostate cancer I went to the head of the department I worked for (she was an oncologist) and asked her advice. She sent me to the radiation oncology department at NCI's clinical center.

    I had a lot of misconceptions when I first walked in. They told me that the treatment would be free and I said - "I have to tell you that I'm not a government employee, just a contractor", thinking that I wouldn't get free treatment. But they said, no, treatment in their trials is free for everyone, not just employees or contractors.

    When I went in to talk to them they told me what trials they had. They said there were two underway that could apply to me and they recommended a particular one, which I joined. They also offered to send me to one of their surgeons if I wanted to find out about surgical options too, but I was happy to stay with them. They were smart, very knowledgeable, and very committed people. I'm thankful for what they did.

    If you want to find clinical trials there are two good places to look:

    clinicaltrials.gov/

    cancer.gov/about-cancer/tre...

    They both use the same database, so you'll find the same cancer treatment trials. They just organize and search the data differently. The clinicaltrials.gov website also has trials for other illnesses such as heart disease, diabetes, etc.

    If you're interested in trials, I suggest spending some time on one or the other website going through the listings. If you find something of interest, don't hesitate to call the phone number listed on the trial. You'll probably wind up talking to an oncology nurse who will know a lot about the trial, be able to answer questions, and may help you to figure out if it's right for Mike.

    Best of luck.

    Alan

  • Great info - we live near Mayo Clinic in Jacksonville, FL - do you think they conduct trials there? - have you heard anything about this from your experiences-

  • Doing some searching, I found this list of Mayo Clinic clinical trials on prostate cancer:

    mayo.edu/research/clinical-...

    Most of them are in Rochester, Minnesota, but there are some in Jacksonville. Be sure to also look at the second page because there are some there too. There may also be trials at other Florida or nearby state locations that are within driving range for you.

    If you see a trial on the clinicaltrials.gov or cancer.gov websites that looks interesting, don't reject it immediately if it's not within easy driving range. It might still be worth a phone call to find out what's involved. Some trials might require you to be present at the facility for an initial evaluation and treatment, but then allow you follow up with your local oncologist if he or she is willing. Some might even have research funds that can help pay for travel.

    I suggest something like the following:

    Spend several hours reviewing the prostate cancer treatment trials on cancer.gov (which may organize them a little better than clinicaltrials.gov - though I'm not sure of that.) Read the purpose and goals of the trial and the eligibility criteria. You'll be looking for trials that aim to knock down the cancer, and are aimed at patients with similar experience to Mike in terms of metastases, stage, PSA, prior treatments, response to prior treatments, physical condition and so on. Make a list of the ones that look most interesting. Perhaps print out the data pages for each one that looks particularly interesting.

    The next step is to find out which of these are the most promising. If you have a set of printouts, you may be able to make an appointment with Mike's oncologist to go over the printouts with you. He or she can tell you which ones look most interesting to him, and also tell you which ones Mike wouldn't qualify for based on complicated technical criteria that weren't clear to you when reading the eligibility criteria. You can also ask questions here on this group. Some people may have ideas about the trials that would be informative for you.

    At any time in this process, you can call the phone number for the clinical trial. You can get more information on whether the trial would be useful for Mike, find out if it's practical for you to go to an out of town location, find out when it starts and whether they expect to be still looking for new patients in your time frame, find out what the chances are of being accepted into the trial and, if so, how soon the treatment would start, and find out whether there are treatment arms and placebo arms. Nobody wants to get a placebo, but sometimes there are 1/3 of the patients in the placebo arm and 2/3 in the treatment arm. It's not always half and half. There may also be an arrangement that, if the treatment looks like it's working, men in the placebo group will get a chance to switch to the treatment before their cancer spreads too much.

    If Mike's treatment is working now, it's not necessarily too early to start looking at trials. It can take some time to get everything setup for participation in the trial, so If you think that the current treatment will only work for a limited time, it might still make sense to begin looking at possible next steps before they become necessary.

    I know how difficult and trying all of this is. If possible, I think it might be a good idea to kind of put this work in a compartment - you'll investigate for an hour or two, then put it aside and not think about it until it's time to take the next step. Working and worrying about it 8 or 16 hours a day probably won't produce any better result than working for just a limited time each day, and it's important to take time to live and not just worrying about living.

    Best of luck.

    Alan

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