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On Active Surveillance? Try an immunotherapy with that.

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Posted 12/30/2014 8:13 PM (GMT 0)
NCI just announced a new clinical trial for men on Active Surveillance. They give half the men a very promising new immunotherapy - Prostvac (the other half get a placebo). Prostvac is a modified virus vaccine that is attached to PSA and an immune booster, so it trains the immune system to seek out and destroy other cells that present PSA. The hope is that it will cause an immune attack against prostate cancer cells in the prostates of men on AS, thus allowing them to stay on AS longer.

The trials have not started yet, but you can email the investigators to get on the list. I think this will be popular. Trial sites are in Southern California (Cedars-Sinai, USC, UC-Irvine & UCSD), Tucson & Johns Hopkins.

Here are the details:
Prostvac in Preventing Disease Progression in Patients With Localized Prostate Cancer Undergoing Active Surveillance

- Allen
Posted 12/30/2014 9:07 PM (GMT 0)
Cant agree with this enough....to include provenge at an earlier stage instead of me where I already had painful Mets and the narcotics disqualified me for it.

No doubt it seems immunotherapy is the future of finding the cure for cancer...it only seems like common sense to me....having your own bodys immune system, which is what failed to work properly in the first place to prevent cancer, to being the best way to attack cancer.....not chemo, radiation which basically tear down your body.
Posted 12/30/2014 9:22 PM (GMT 0)
I inquired about the trial and got a reply from Dr Posadas (Cedars-Sinai Medical Center) that "This trial is closed to accrual." Not sure exactly what that means but maybe the waiting list is full. Also inquired to USC but no reply yet.
Posted 12/30/2014 10:32 PM (GMT 0)
...or it may mean they aren't accruing yet.
Posted 12/31/2014 8:48 AM (GMT 0)
Winmui has been posting me about cometriq which seems to control bone mets in thyroid c patients but failed clinical for pc. Any chance the medonc would prescribe off label to use in conjunction with radiation? Gotta figure out a way to keep it at bay until the immunotherapy gets fda approval or a clinical trial that fits Gary (and Casper) comes along.
Beth n Gary
Posted 12/31/2014 3:35 PM (GMT 0)
Thanks Allen, I just emailed my Uro (Dr. Ukimura) at USC indicating my interest in participating in the trial. Looks like recruiting won't start till March of 2015.
Posted 12/31/2014 7:55 PM (GMT 0)
Thanks for the update, akai. There are a few guys in my PC Support Groups on AS. I will hold off telling them until March then. Please let me know if you hear further updates - the info on the clinicaltrials.gov site often lags behind.
Posted 1/1/2015 9:38 AM (GMT 0)
Good to see the trial but it is a question that is 20 years in the answer. Or more. I would defer to long term results of the SELECT trial that showed that the supposed benefitting agents, Vitamin E and Selenium, were in fact associated with more aggressive prostate cancer occurrence ratios. We have to answer a tough to answer question with men on active surveillance. This due to long term survival for these men. A good thing but it makes for the need for long term trials and they are not cheap. But this is a good trial.

Thanks as always for the great posting Allen.
Posted 1/1/2015 10:35 AM (GMT 0)
This is a 3 year trial. They are measuring success by an enhanced immune response and by follow-up biopsy results.Twenty year trials of treatments are typically useless.
Posted 1/1/2015 1:17 PM (GMT 0)
Thanks Allen. Wonder if I would be considered on Active Surveillance. Will have to look at the inclusions and exclusions.

Years ago many thought it made common sense to start chemo early...and several years later it showed a huge difference in survival benefit. Immunotherapy seems to make common sense when done early.

Tony- I don't understand your 20 year point. Won't we have some answers after 3 years? ....or are you refereeing to the Protect trial for Provenge where there are no answers like after 13+ years? For which it would be nice to get some answers on that...and that probably will be 20 years...

/www.clinicaltrials.gov/ct2/show/NCT00779402


I wonder if it will be like Provenge where you can't use psa to monitor its effectiveness.
Posted 1/1/2015 6:23 PM (GMT 0)
Jerry L-

You are definitely not on Active Surveillance or even Watchful Waiting. Men who have been treated don't fall into those categories.

All men after treatment, including you and I, continue to be monitored after what seems to be successful treatment.

These 20 year studies leave me shaking my head. What therapy (or technology) remains unchanged after 20 years? They are irrelevant before results are published.

- Allen
Posted 1/1/2015 6:48 PM (GMT 0)
Allen,

I know that I'm not...but I feel like I'm on guard and the term Active Surveillance just seems fitting.

Question for you and I don't know if you'll know or not, but thought I'd ask...

Primary Outcome Measures:
Change in CD8+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies [ Time Frame: Baseline to up to 14 days after the last dose ] [ Designated as safety issue: No ]

A two-sided two-sample t test will be used to compare the change in CD8+ positive cells in tumor tissue between the treatment and placebo groups. A subgroup analysis will be performed to compare the change in CD8+ positive cells between study groups in specimens collected by targeted biopsy.

Change in CD4+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies [ Time Frame: Baseline to up to 14 days after the last dose ] [ Designated as safety issue: No

A two-sided two-sample t test will be used to compare the change in CD4+ positive cells in tumor tissue between the treatment and placebo groups. A subgroup analysis will be performed to compare the change in CD4+ positive cells between study groups in specimens collected by targeted biopsy.
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I've had my blood tested several times...in fact-monthly...for immune system. For example, CD4, CD8, etc.... do they take samples of blood near the tumor to check these immune blood tests? Or do they just take blood like a normal blood test...from your arm? Just found that interesting..
Posted 1/1/2015 7:42 PM (GMT 0)
I agree with you that it's an interesting test. It looks like they are only looking in the tumor environment. It's one thing to get a build-up of leukocytes in the serum where they freely circulate. It's quite another issue as to whether those CD4 and CD8 cells will actually infiltrate into the blood-poor, sometimes hypoxic, tumor area and mount an attack. And will they attack healthy prostate tissue that presents PSA?

- Allen
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