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Posted 6/19/2012 3:52 AM (GMT 0)
Apologies if this was already posted, from PubMed. It says that in a group of men who have had initial therapy for PC and now have a rising trend, taking daily pomegranate supplements leads to a significant lengthening (improvement) of PSA doubling time. But there are some weird bits in this abstract that don't quite make sense. Argue away!!!!


A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer.

Authors: Paller CJ, Ye X, Wozniak PJ, Gillespie BK, Sieber PR, Greengold RH, Stockton BR, Hertzman BL, Efros MD, Roper RP, Liker HR, Carducci MA.

Source: Prostate Cancer Research Program, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.

Publication: Prostate Cancer Prostatic Dis. 2012 Jun 12. doi: 10.1038/pcan.2012.20. [Epub ahead of print]


Background:Pomegranate juice has been associated with PSA doubling time (PSADT) elongation in a single-arm phase II trial. This study assesses biological activity of two doses of pomegranate extract (POMx) in men with recurrent prostate cancer, using changes in PSADT as the primary outcome.

Methods:This randomized, multi-center, double-blind phase II, dose-exploring trial randomized men with a rising PSA and without metastases to receive 1 or 3 g of POMx, stratified by baseline PSADT and Gleason score. Patients (104) were enrolled and treated for up to 18 months. The intent-to-treat (ITT) population was 96% white, with median age 74.5 years and median Gleason score 7. This study was designed to detect a 6-month on-study increase in PSADT from baseline in each arm.

Results:Overall, median PSADT in the ITT population lengthened from 11.9 months at baseline to 18.5 months after treatment (P<0.001). PSADT lengthened in the low-dose group from 11.9 to 18.8 months and 12.2 to 17.5 months in the high-dose group, with no significant difference between dose groups (P=0.554). PSADT increases >100% of baseline were observed in 43% of patients. Declining PSA levels were observed in 13 patients (13%). In all, 42% of patients discontinued treatment before meeting the protocol-definition of PSA progression, or 18 months, primarily due to a rising PSA. No significant changes occurred in testosterone. Although no clinically significant toxicities were seen, diarrhea was seen in 1.9% and 13.5% of patients in the 1- and 3-g dose groups, respectively.

CONCLUSIONS: POMx treatment was associated with ~6 month increases in PSADT in both treatment arms without adverse effects. The significance of this on-study slowing of PSADT remains unclear, reinforcing the need for placebo-controlled studies in this patient population.

Prostate Cancer and Prostatic Diseases advance online publication, 12 June 2012; doi:10.1038/pcan.2012.20.
Posted 6/19/2012 4:04 AM (GMT 0)
There are a ton of guys here at HW with recurrent PC who take POM to help slow down growth since there have been so many positive medical studies demonstrating this (and other non-PC benefits, too).  POM is not a cure for PC, but most guys just want to slow the b**** down!

proscapt said...
... But there are some weird bits in this abstract that don't quite make sense.

Which part didn't you understand?

Posted 6/19/2012 5:09 AM (GMT 0)
Here's what's puzzling to me:

It says:

"In all, 42% of patients discontinued treatment before meeting the protocol-definition of PSA progression, or 18 months, primarily due to a rising PSA."

That seems say 42% of patients discontinued the POM treatment and left the study BEFORE their PSA progressed, but then it says the reason they left was "primarily due to a rising PSA" And so that seems to be a contradictory statement. How do you read it?
Posted 6/19/2012 1:49 PM (GMT 0)
proscapt,

I will give a direct answer to your question below, but as a background I believe that the root of your question about the Carducci study lies in the realization that not everyone responds in exactly the same to this (or any) treatment, based on the biology of their own unique bodies and the biology of their own unique cancers.

You may have noticed from the abstract you copied/pasted that PSADT at least doubled (doubling PSADT is favorable, meaning PSA increases slowed down by half or more) in 43% of the patients. Wow!

You might have also noticed that the PSA of a sub-set of that group of participants (13%) actually slowed so much that it went down during the study. Double WOW! Dr Nick Vogelzang (very noted PC specialist, and the doctor of at least several men here at HW) called the results “dramatic.” (He reported that he recommends pomegranate extract or juice “a lot” for men in his practice with rising PSA.)

Clearly, for the rest of the participants, their PSADT either improved at a lower rate, or their PSA continued to progress at the predicted rate for the duration of the study (up to 18 months) or their results were somewhere in between these. The sentence you have highlighted indicates that out of this group of participants, many decided to no-longer forego any/all additional therapies (as required by the study), and so they dropped out of the study to pursue further treatment.

proscapt, if I further “read between the lines” of your question, I might proactively point out that in an “intent-to-treat” (ITT) analysis, the results of ALL participants are included in the results of the original groups to which they were randomly assigned, regardless of subsequent withdrawal from the program or deviation from the study protocol. So the PSA changes of all those 42% who dropped out (many because of rising PSA) were also included in the final median increase of PSADT from 11.9 to 18.5 months. Digest that, and you can see that for many (not all) men the results were indeed "dramatic!"

For completeness, one should note that different types of studies, for example, a “per-protocol” analysis, would have excluded the results of those that dropped out, but the Carducci study was an ITT study which included all results.

For further completeness, also see my description of "median" HERE; skip down to about the 5th post in this thread.

Does this help…?
Posted 6/19/2012 3:54 PM (GMT 0)
An increase of PSADT from 11.9 to 18.5 months?  I'd say that is downright amazing.

 

Can we assume that if it slows the PSA down, that it corresponds to cancer growing slower?  Just thinking out loud here.  Has there been any studies showing the effect of it on PC other than PSA?

Posted 6/19/2012 5:08 PM (GMT 0)
Hi Jerry L., I agree it was dramatic for an over-the-counter treatment...especially when you keep in mind that the was the median result, and that it included all the participant results aggregated together. This just goes to show the possible significance of the lifestyle choices on disease progression/risk reduction.

It’s baffling to think about what people will subject themselves to (surgery, radiation, chemical/hormone treatment) to stop or slow their cancer growth while not undertaking the far less radical steps that are within their direct control to slow their cancer growth and prolong life…like diet, nutrition, exercise, etc...even when they are equiped with the knowledge. Most men cannot make the cancer disappear with a change in lifestyle, but these results are indeed "dramatic."

Regarding your question, the answer is "yes." D'Amico demonstrated quite a while ago that PSA progression correlates as an indicator of prostate cancer progression, and it has been used in all studies since then. The known exception is when Avodart/Finasteride is used since it shrinks the physical size of the prostate/tumor which reduces the amount of PSA production.
Posted 6/19/2012 6:44 PM (GMT 0)
Casey:

You are correct on Avodart when one has a prostate.

After RP, I haven't gotten an answer on that issue (ie: with a prostate, when on avodart, the general rule is to double the PSA reading to get a more accurate figure).

Do you have any information on interpreting a PSA reading when on avodart post RP?

Mel

Posted 6/19/2012 8:50 PM (GMT 0)
one of my radiation oncologists told me after treatment that he believes in a very small percentage of cases pomegranate could prevent prostate cancer.  during treatment he was really very cool to even talking about supplements.

ed

 

Posted 8/30/2012 3:53 AM (GMT 0)

I undderstand Phase III of trial of pomegrante in slowing PSA doubling time is completed. Does any know the results? Are they as good as that of Phase II trial?

Posted 8/30/2012 4:56 PM (GMT 0)
It is important to remind all that these studies were done only on patients that are having a reoccurrance after primary treatment. In these cases psa is a very reliable indicator of cancer growth as the prostate is no longer there to influence psa readings. PSA is much more reflective of cancer growth after treatment and is used to determine treatment failure, when to start salvage treatments and to monitor if HT is working so it is a true indicator of cancer and not other issues.
It would be difficult to explain a reduction in PSADT other than it truely being reflected in a slowing of the cancer's growth.
Posted 8/30/2012 5:25 PM (GMT 0)
John - that is the issue I face in trying to decide whether to take Pomx in an effort to reduce the chances that I get prostate cancer (despite high risk). The studies are all post treatment. Still, it seems to me probably more benefit than harm - putting aside the cost, which (fortunately) is not material to me.
Posted 8/30/2012 5:46 PM (GMT 0)
Don't expect to see a "proof" of preventative benefits any time soon via the gold standard prospective, double blind, carefully controlled clinical trial with a large sample of flavonoids & resveratrol in red wine, but there is good scientific evidence.

Pomegranate contains more antioxidents than red wine. Concord grape juice is loaded, too.

There is emerging evidence that prostate inflammation may significantly contribute to prostatic carcinogenesis, and parallel evidence that anti-inflammatory and antioxidant drugs (a.k.a. targeted chemoprevention) can attenuate PC.

Your approach, medved, to try to attenuate PC, is plausible (LINK)...but maybe you want to wait around for more "proof?" (maybe not)

As JohnT points out, the initial pomegranate studies have focused on the much more measureable PSADT for men with recurring disease (the results have been very good!)...prevention is very hard to measure.
Posted 8/30/2012 8:23 PM (GMT 0)
Thanks Casey. In my mind, the decision regarding whether to "try it now" or "wait for more proof" depends on the downsides/risks. If there were no risk or downside other than $25 a month, I would give it a try, on the chance that it might do some good. If there might be more downside, I would want more "proof" that it does some good.
Posted 8/30/2012 9:41 PM (GMT 0)
Med,
I hear you. I think it is a stretch to say that pom can prevent cancer. I have no signs of a reoccurrance, but I take one pom extract pill a day. The only downside I see is that I get one extra serving of fruit per day. With so many men taking pom I think that if there was a problem it would have shown up by now. Pomegranites have been eaten for thousands of years and many attributes have been given to them, most of which are just wives tales, but I surely don't see any downside in taking it. I don't see how taking any type of fruit can be bad for you.
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