There has been an on-going debate on the advanced prostate cancer on-line support group about the issue of the efficacy of Provenge in light of the expectation of a person’s increasing PSA number while getting the treatment. For many men with advanced prostate cancer this is a reason they elect to pass on this treatment option. Many men even question the efficacy of the treatment.
I understand how difficult it is for anyone with advanced prostate cancer to go through a treatment and watch their PSA continue to increase and not question if a therapy is working. Most of the treatments we have do work quickly and we do see a PSA change if the therapy is effecting our cancer. Provenge does not work that way, it is not an instantaneous therapy and it will not lower or even stop the PSA from continuing to increase, this is the simple truth.
Provenge, when it works, takes time to train the immune system to fight the cancer. When the white blood cells are removed (the disease fighting cells) less than 1% of them are taken from the donor and treated with the PAP protein (which makes Provenge). The treated white blood cells are then returned to the donor and circulate through the body with the goal of sensitizing the other, untreated white blood cells to the cancer.
It does take time and yes, the PSA continues to increase while this process happens. This is scarey for anyone with advanced prostate cancer.
We have all been trained to monitor our PSA as a biomarker of our disease progression and yes, our disease does progress during this phase of treatment. Until the returned, treated white blood cells are able to “educate” the 99% of the untreated cells our disease will progress and our PSA will continue to climb. No question, this is nerve racking and most difficult for all of us. It does take nerves of steel.
This is why I believe it is important to have Provenge immediately when you become castrate resistant, while the disease (and the PSA) are still low.
Like any other treatment we have it will not work for everyone. Some of us will not receive any survival benefit, but more of us will than those who do not. I am told that here are men who are still alive today who were in the clinical trials used to obtain the FDA approval (I have no way to actual verify this statement).
Another concern that has been expressed on the group is that there has not been any non Dendreon sponsored studies that have been done to try and confirm the survival advantage of Provenge. This is true, there have not been any, but I would not expect to see any. This is a valid comment and should be considered when evaluating any research. However, the reality is that none of our current treatments (that I am aware of) has had any non sponsor research that duplicates their survival results. Why would a company that will not make any money from a product spend the millions of dollars required to do this research? Looking at who pays for research is always a good idea, but rejecting research conclusions when the results have been peer reviewed as they have been for Provenge should not be automatic.
The FDA carefully monitors the research protocol besides being actively involved in the actual research design of all clinical trials, including the three phase III trials of Provenge. Yes, the FDA has made mistakes and approved drugs that were eventually removed from the market. These removals, that I know of, are for safety issues, not efficacy issues.
Prior to its approval the FDA included an analyses of data from three separate Phase 3 trials (not one as some believe) in men with metastatic castrate resistant prostate cancer (Studies D9901, D9902A, and IMPACT). The data from all three studies was then integrated to examine the treatment effect in a larger group of men.
We can only hope that the scientists at Dendreon are able to develop a tool that will let us know if we are one of those individuals that can benefit from Provenge, until that time all we can do is hope that the statistical advantage (group trend) will work in to our own personal advantage. Again, my best recommendation is to jump on Provenge as soon as you become aware that you are castrate resistant.
Each of us should come to our own conclusion about any treatment available. It is important to we try and wrap our mind around as much information as possible, even when the information is in conflict. It is also important to always keep your mind open to new and additional information. It is our personal job to evaluate what we hear and learn and try and integrate this into what we feel will work for our self. The right answer for one of us is not necessarily the right answer for another. There is no universal right or wrong, just what we are comfortable with for our self.
Okay, the PSA test is almost irrelevant. I did a quick search and discovered that there are about 20 million PSA tests performed each year in North America – and an equal number throughout the rest of the world. Will this recent finding bring about a reduction in PSA tests?
At the moment, they’re consider standard practice. How would one go about making sure it was no longer such a standard? I would imagine tat the livelihood of many people depend on the continued use of a test, which has now been shown to be irrelevant.
Rising PSA is not the only concern of patients treated with Provenge. Many people who have had Provenge report increases in the spread of the cancer and increased bone mets. Where is the evidence that Provenge works at all when it cannot even bring down the PSA or stop the cancer spreading ?
Simply, the evidence is in the IMPACT trials that showed a survival advantage to men who received Provenge over the control group. The survival advantage was there despite the ” crossover” of men from the control group to thr treatment with “Frovenge.”
Joel- Is there literature to support your statement that PSA increase is simply due to the delay in provenge action?
Rebecca- If you go to the New England Journal of Medicine (http://www.nejm.org/doi/pdf/10.1056/NEJMoa1001294) the Kantoff article on pages 415 and 416 reports that the median time to both objective and clinical disease progression between the placebo group and the treatment are not different. It does report a difference in PSA kinetics with the better response coming from the treatment group, but this difference is not statistically significant, thus the disease progression and the PSA changes are the same between the placebo group and the treatment group. Despite the fact that the cancer continues on its progression and the PSA continues to rise at the same rate, the treatment group experienced a longer survival. – Joel
just completed provenge treatment and my PSA went down to
152 after having risen to 856 in about a month before start
of Provenge. Just finished treatment and seems to be working.
Googling tells me that it does not kick in before 6 months.
I asked for it and oncologist said it was just what he had in
mind! I was diagnosed about 2 years late wit stage 4 metastasized prostate cancer. Failed Eligard and Lupron over 2 year period after diagnosis and was symptom free (thank God)
so I askied for Provenge. Still can’t urinate and wear an
indwelling foley catheter. Change it myself and now and then
go w/o it. On Methanine Hippurate 2x a day.
I was diagnosed 2 years 2 months ago with stage4 metastasized
prostate cancer. started radiation treatments (14 fractions)
4 first week, then 5 second and third weeks. Exteranl beam,
very focused to severe bone pain right hip, right shoulder.
Bone mets in sacrum, spine, right femur,right shoulder, some
in a lung, a rib, and skull. Hip and shoulder very painful.
Also started Eligard, Bicalutamid, etc. Then went to Lupron.
Pain gone, but failed both hormonals. No bone pain after 2 years so asked for Provenge. PSA at diag was 356, dropped to
1.9 and climbed in 2 years to 356 then in a month before Provenge to 856! Just finished Provenge last week and PSA is now 152. I was told PSA would keep rising, however, I am happy with 152. Hope it goes lower in next several months.
Takes 6 months to fully stimulate immune system. Nurses
noticed the Provenge infusion was a really pretty red color!?
Had bad reactions to all three infusions and got Benadryl IV
on third infusion. I survived. Leukaphoredis at RI Blood Ctr
and infusions at Miriam Hospital (Rhode Island Hospital at
Miriam Hospital Cancer Ctr.) Oncologist has plans for follow-up
hormonals, Doxitaxel, PSMA, Xfigo, etc. He gave me a whole list. Will decide asa I go along and consider QOL issues.
I am also on monthly infusions of Zometa for calcium loss
from bones. I am also on Methenamine Hipp from Urologist to
prevent new urinary tract infections. I already have Klebsiela
and another infection in bladder. So far no probs, but doc says call if I have fever, chills, etc. none yet. I change my indwelling Foley myself. Now and then just using a red rubber intermittent for a break to prevent irritation from the Foley attached to leg bag. Gives me a chance to “feel normal”
for a few hours. I feel good in general, some fatigue now and then, but I am 74 and was diagnosed about 2 years late!
I am happy with the cancer as I have done things I would not have done before. Since I feel great I am more outgoing, even
having emailed a guy I have not seen in 27 years. He was 10 years old then and is now a world famous classical musician.
Has invited me to NYC to hangout and have drinks after concert!
Marco, – It sounds as if you a fast responder. Usually we don’t see responses so quickly and I strongly recommend that men have Provenge as soon as they become castrate resistant so as to increase their opportunity to become responders. No matter, you seem to have a great immune system that was able to become quickly primed. Now that you have completed Provenge you should be moving on to your next treatment which could relieve (along with the Provenge) your bladder obstruction. – Joel
The bottom line – ENJOY your life. – Joel
My oncologist wants to follow Provenge with Zytiga. Since my
testosterone levels are low and currently on Lupron I am
tempted to forgo Zytiga for now. Less is better is my idea.
What is the “next treatment” along with Provenge that might
relieve my bladder obstruction? it seems to me that it would have to be a treatment that would significantly shrink my
prostate. Is there such a treatment?
I do enjoy life with contacts with good people.
Marco- Proscar or Avodart might shrink your prostate and it would also contribute to your ADT. – joel
For a couple of years before my diagnosis of stage 4 PC I was on Finasteride. My physician at the time failed to diagnose
my advanced stage cancer and just prescribed that drug, but
I went off it at diagnosis because it was ineffective. Right now I have a good feeling about my Provenge treatment. I do
get fatigued, but in general I feel fine. I guess I will make
decisions based on quality of life issues from now on. It might
mean going against doctors’ orders now and then, but I trust
my own intuition and feelings.
For the present I am leaning against Zytiga treatment and as for Docetaxel I am quite sure I do not want it at all.
It’s “chemo” and seems to kill off cancer cells and healthy
cells. At present I put great faith in my Provenge stimulated
white blood cells to combat the cancer cells effectively.
I may be wrong, but I feel good about it.
On April 6th I said my PSA went down from 856 to 152. Not true
as oncologist pointed out to me that PSA was at least 152 (>152) and that I may be in the thousands by now. It seems that
PSA rise is irrelevant after Provenge. Two oncologists told me
it would continue to rise. Don’t worry about it. I asked if
some day high elevated PSA would come back to kick me in the ass. Don’t worry just call me immediately if you have flu like
symptoms or bone pain. So far, so good neither has happened.
Now 2015 and 6 months after Provenge started Xtandi, switched from Zometa to Xgeva and added Xofigo for 6 months. Doctor extended Xtandi for
additional 6 months. Had a PET scan before Xofigo and it showed significant metabolic bone activity on every bone from head to feet! Entire
skeleton involved with exception of one vertebra. Feeling just fine and on my own have added pure licorice extract to my regimen to lower testosterone.
Against advice of oncologists I have given up taking Luoron every 3 months. Been off Lupron for a year.
So I will for the next 6 months be on Xtandi, Xofigo and Xgevaall at the same time. PSA, ALKPHOS, are down and
Testosteron went up to and holding around 120’s. I think it is low enough not drive the cancer,but high enough to
make me feel good. It is my belief that licorice is achieving the testosterone level and maintaining it.
Discovered licorice by googling “testosterone licorice” and that led me to Italian study on NEJM. Any pure licorice
extract will work from health food store or on line will work. Swanson Products on line has a water extract.
Nuclear med nurse laughed and doctors all say they will look it up! Hey! they all laughed at Christipher Columbus!
Seems time that licorice beats Luoron any day of the week! Only side effect is makes your tongue black!
I tell people I might have bubonic plague! haha! Thing is I feel great!