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Modified Citrus Pectin and PSA doubling time

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Posted 6/28/2017 1:05 PM (GMT 0)
Interim results regarding MCP and PSA doubling in non metastatic recurrence group. Looks interesting.

/prostatecancernewstoday.com/2017/06/27/modified-citrus-pectin-shows-potential-relapsed-prostate-cancer-preliminary-study-results/
Posted 6/28/2017 1:58 PM (GMT 0)
The study is a phase III clinical trial. Here's a link to the entry in clinicaltrials.gov: Effect of Modified Citrus Pectin on PSA Kinetics in Biochemical Relapsed PC With Serial Increases in PSA

It's a farly small study. Their stated target is 60 participants. They are scheduled to release their findings this time next year.

According to the clinical trials listing they are still recruiting. They follow each patient for six months so they'll have to cut it off soon. If you want to sign up you'll have to hurry. And, of course, the study is being done in Israel and for many of us the travel might be a problem.
Posted 6/28/2017 2:01 PM (GMT 0)
uh oh,
Someone needs a lecturesmile

=
We are constantly looking for natural options that affect cancer progression with minimal side effects. Based on the intermediary findings of the study, MCP has the potential to fall into this category with patients affected by prostate cancer,” added Frenkel, who is also the director of the Complementary and Integrative Medicine Unit in the Institute of Oncology at Meir Medical Center.
Posted 6/28/2017 4:12 PM (GMT 0)
Another POS study to sell a supplement. I'm surprised they call that a Phase 3 study - seems Phase 2 to me. There is no randomization. You'd think they would have learned from pomegranate studies that PSA kinetics are a useless outcome to use as a primary result.
Posted 6/28/2017 5:27 PM (GMT 0)
Tall,

I think you are a bit hard on Potential Oncological Support (POS) studies.

Yes, this sort of study produces a low order of evidence, and yes, there is a risk of bias, but I give the researchers some credit for registering as a clinical trial, documenting ahead of time who they are, what they will be looking for, and how they propose to go about it.

This sort of study, as well as mouse and in vitro ones, are most useful for steering further research.
Posted 6/28/2017 6:29 PM (GMT 0)
I think that it is now a government requirement for clinical trials to list on the NIH site. However, NIH doesn't vouch for anything. So, for example, labeling it a Phase 3 trial is an obvious error.

It's not just bias - it's erroneous - high degree of false positive benefit. Johns Hopkins showed that PSADT cannot be used as a surrogate endpoint for efficacy absent of placebo control (RCTs). They found that "Up to 62% of 50-patient single-arm simulations detected significant PSADT change, whereas simulated RCTs did not.

Johns Hopkins said...
These data suggest that calculated PSADT in biochemically recurrent PC may naturally increase over time in the absence of therapy and may be influenced by duration of PSA follow-up. As a result, single-arm trials could show false significant increases despite the lack of active treatment of these patients. Placebo-controlled RCTs including clinical end points are recommended to screen novel agents in men with BRPC to mitigate bias because of natural PSADT variability.

/www.ncbi.nlm.nih.gov/pmc/articles/PMC3945997/
Posted 6/28/2017 8:49 PM (GMT 0)
If you search Pubmed for prostate cancer, you will find hundreds of herb, drugs, supplements that can hinder or kill prostate cancer in the in vitro (test tube). Unfortunately none of these have shown any positive outcome in vivo trials. On the positive, if people want to waste their money and if it provides positive placebo outcome, then go for it.
Posted 6/28/2017 9:37 PM (GMT 0)
Tall,

I take your point about using PSA kinetics as an endpoint, especially in a single-arm trial.

The MCP trial had been going on for a year and a half when that Hopkins study came out. The Hopkins result will certainly further reduce the meaning of their findings.
Posted 6/28/2017 10:22 PM (GMT 0)

PeterDisAbelard. said...
Tall,

I think you are a bit hard on Potential Oncological Support (POS) studies...........

Oh, so that is what Tall meant by POS! I thought he was being REALLY hard on them!
Posted 6/29/2017 8:20 AM (GMT 0)
hard on them...nah...opinionated...yea...which is not the same as having an opinion...the nuance of the 2 words is slight...tho with a sign ni ficant bite
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