Posted 11/16/2018 10:34 AM (GMT -7)
I have just completed one year on an immunotherapy study at Memorial Sloan-Kettering in New York City. Below is a summary of my experience to date. Perhaps other members with immunotherapy experience would care to add to this thread.
My Background: I had surgery in upstate NY in the fall of 2009. I am a Gleason 8. Surgery had clearly failed by the summer of 2011, though my surgeon engaged in denial at that time. I consequently moved management of my case to MSK in the fall of 2011, not expecting miracles, but figuring MSK had a very deep bench and more ready access to clinical trials, should things come to that. I undertook SRT + HT (Lupron + Casodex) in the winter on 2011-12 at MSK. My PSA stayed undetectable until January 2015, emerging again at .08. Since then, my oncologist undertook no treatment, other than three month PSA, other blood work, and scans. He and I extensively discussed the not inconsiderable SE of HT during this time, and he listened to my thoughts that I would prefer "to feel like myself" for as long as possible. In October 2017 my MO asked me to consider participating in an immunotherapy trial using a vaccine approach to combating PCa. The agent of this approach are a set of viruses collectively called PROSTVAC.
PROSTVAC Study: The study is currently active at MSK, Dana Farber, and I believe NIH. The study is limited to 80 men with biochemical recurrent prostate cancer who are still found as non-metastatic, castration sensitive (nmCSPC). This Pase 2 study is limited and specific in its goal: "to determine if an immunotherapy vaccine product called PROSTVAC can decrease tumor growth rate as measured by PSA compared to a group getting surveillance alone." PROSTVAC has been around for a while. As a matter of record, a much larger Phase 3 study of men with advanced, metastatic disease was cancelled in Sept 2017 as the treatment was found no better that placebo. I believe the study I am participating in is kind of a "last ditch" effort to find benefit for a population with less advanced disease.
Treatment consists of two viruses administered by subcutaneous injection administered monthly over six months. The first injection is a form of the vaccina virus. This is a "live" virus which has been genetically modified to hopefully produce an immune response to PSA expressing cells. Follow up injections are of the fowlpox virus. This is a "dead" virus and is used to further stimulate the immune system. One important point to note about PROSTVAC, in my view, is that all the "heavy lifting" has to be done by a patient's immune system. Nothing is tailored in or outside the body to specific patients. To work a patient's immune system itself must generate an antigen response, then create effective and numerous antibodies to do the job.
Study Method: Patients are randomly assigned one of two arms: Arm A consists of injections for six months, followed by six months of surveillance; Arm B is the opposite, six months of surveillance followed by six months of injections. I was selected for Arm B. Throughout I was monitored by monthly PSA tests, extensive other blood work, and CAT and bone scans at the outset, the mid point, and the end point of the first year.
Eligibility: Some of the more salient eligibility requirements, in addition to being seen as nmCSPC are: PSA doubling time > 5 months, but <= 15 months; no history of chemo; no immunotherapy in the past three years; no other malignant disease; general good health.
My results: As I mentioned, the study's goals are limited -- to measure the effect as seen on monthly PSA tests as opposed to surveillance. This how it has gone:
Nov 2017: 1.05 (start of surveillance; scans negative)
Dec 2017: 0.98
Jan 2018: 1.05
Feb 2018: 1.17
Apr 2018: 1.25
May 2018: 1.32
May 2018: 1.47 (start of injections; scans negative)
June 2018: 1.68
July 2018: 2.00
Aug 2018: 1.93
Sept 2018: 2.13
Oct 2018: 2.12
Nov 2018: 2.17 (scans negative)
My Conclusions and Future Participation: Based on PSA doubling time and scans, I am eligible and will participate in a second year of the study. This will consist of quarterly fowlpox injections. Monthly monitoring will continue. I have experienced no SE from the injections, not even a rash at the injection sites. I discussed my year-to-date with my MO this week, and he said there is no way yet to draw conclusions from this year of individual data. Better idea in a year or so when all participants have completed at least one full year. Obviously I am glad to see PSA hovering in a fairly narrow range since July, but who is to say what next month will reveal? My personal goal has not been a "cure," but rather to slow things down to put off the date that will require starting HT again. Best wishes to all!
Age 75; Gleason 8
Surgery fall 2009 in upstate NY. surgery failed by summer of 2011.
Moved my case to Memorial Sloan Kettering in NY City, fall 2011
SRT + HT winter 2011-12; PSA "undetectable" until Jan 2015.
Steady rise since 2015. Latest 2.15
Currently in PROSTVAC immunotherapy trial. Monthly recombinant virus injections to stimulate immune response against PSA expressing cells.