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.
Estradiol Clinical Trial in UK?
Chemo/Pluvicto or Clinical Trial?
Clinical Trial vs. Zytega
Lu-177 Clinical Trial
Entering Clinical Trials
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).