Alternatives to fereheme

We are posting this again, per suggestion of a fellow member, with a new subject line to hopefully attract some folks that are dealing with similiar stats: (appologies to those that have already read our post and much appreciation to those that have already responded)

It has been almost a year since my husbands rp. It has been an unbelievable ride with additional 9 day hosp stay I month after surgery due to JP drain block (excess fluid). In this past year many things have happened, lost both of my husband’s parents, significant skin cancer/surgeries for me, we have both lost jobs. We read your posts and so appreciate all the sharing! As all of you, our new normal now includes medical appointments and medical decisions many times not knowing which way to go or what to believe. So here we are, one year out, reaching out to all of you for help.  After surgery we learned results:  Gleason 9, pT3B, pN1, Mx with 1 positive margin. There were 2 nodes (above bladder) out of 11 pos. Psa at 6 weeks came back 0.7 and dropped to 0.3 in Oct 2011 and then up to 0.56 in Jan 2012. Shortly after surgery we went to Columbia. One Dr. wanted to start HT and other Dr. was strongly in favor of diet and supplements. We went with diet and supplements as a trial as we continued to gather more info.  Up until Jan the psa was continually going down. When it started to rise in Jan to 0.56 we went to see Dr. Myers. His opinion was that we are going for cure.  We were scheduled at Sandlake for imaging until we learned that my husband could not have fereheme due to  a genetic mutation that could cause possible iron overload. Because there is not another test that can show this detail we are in holding pattern.  Dr. Myers prescribed avodart and celebrex in Jan and was not in favor of starting HT.  HDT dropped and psa is at 0.4 now.  We are going to see all docs in the next three months and will be gathering info for the path forward. ED is OK with pump and meds (amazing since one nerve removed and the other reattached).  Incont. is an issue but not our biggest worry. Have been through biofeedback, etc. We reach out to all of you in hopes that you may see something here and be able to shed some light that will help us in this ever changing and complicated pc world.  Your experience is invaluable and your opinions will be so appreciated. We do not have any bias just want best path forward. Fyi- My husband is 58 yrs old, very active, with no other health issues at this time . Your experience is invaluable and your opinions will be so appreciated.

I beg to disagree with Tony. Although it is true that there have not been randomized control trials comparing these scanning methods+radiation to small mets vs. other approaches, this should certainly be attempted as part of an individualized attempt at cure. I have heard a surgeon who says that removal or radiation of positive nodes brings cure in 1/3 of cases. As to question by Searchmode, I have a question for you: What has Dr.Myers recommended as a next step? He is certainly aware of Cholin CT scan that Tony mentions. I believe this scan recognizes mets only in lymph nodes. For bone mets sodium F18 scan is to date more sensitive than the traditional bone scan. Here in Germany CT Cholin scan is already advertised for prostate patients, and is available at quite a few places throughout the country (example: http://www.radprax.de/radprax-leistungen/igel/maenner/dok/222.php). With your husband´s small PSA, it is probably that the cancer is in one of the lymph nodes. Good luck, whatever you decide. And all the best for you both.

The Wake Forest University C-11 Choline study has been suspended.
This agent (or C-11 acetate) is in use elsewhere, including Tucson (Banner Hospital) and Mayo Clinic. It requires a cyclotron to create the isotope which must be used promptly before radioactive decay.
Is it as good? I do not know. Is it better than Feraheme? We are unlikely to know for quite some time, perhaps never.
Feraheme and its Combidex brother agent have been used for years and the side effects in cancer patients has been nearly zero. The effects and dose in chronic kidney disease patients, its indication, may well be different.
By the way, Mayo also uses Feraheme for rectal cancer imaging.

Also disagree with TC. The same warnings appear on most common drugs we regularly take including aspirin. Combidex was not approved because it was submitted for a number on cancers, but the data in the trials was for PC only. I don't have any data on the Feraheme scans, but I understand that they are less sensitive than the old Combidex.

Sirinum, which was the nano iron agent used in Combidex, most likely has the same isssues as Feraheme as relating to excess iron. It did cause backpain if given too quickly and had to be delivered in over an hour. In the thousands of patients given Sirinum, there was one death that could not be positively attributed to Sirinum.

As to the value of the scans, I can speak to personally as they changed my treatment plan significantly. With a psa of 40 the recommended treatment was at least full pelvic radiation and full body radiation was recommended along with at least a 1 year course of ADT3. A clear Combidex scan enabled me to avoid this treatment.

If less than 5 lymphnodes are detected, Dr Myers feels that a cure can still be affected with radiation or removal of the nodes and a course of HT. How can this not be valuable to patients in this situation?

This is from AMAG the manufacturer of Feraheme.

www.amagpharma.com/products/feraheme.php

This product is NOT approved for scans and has never passed a trial and received FDA approval in the labeling for use as an MRI contrast. But 1 Phase I clinical trial is available at the National Institute of Health:

clinicaltrials.gov/ct2/show/NCT01296139?term=feraheme&rank=17

if anyone would like to get a Feraheme scan I strongly suggest that they do so in the clinical trial. This will help clear the air. Combidex did NOT pass European trials and when the agent ran out the manufacturer decided, for whatever reason, to discontinue the research to market it.

The studies at both Wake Forrest and at Mayo have been suspended with C11 Choline. I am not sure why and I have not been able to locate the reasoning at the clinical trials website. These were phase III trials and there may very well be a great reason to have stopped them such as side effects and simply not useful. Another possibility is that they're use did't affect PCa survival...I don't know yet but I am enquiring...

But this is my point. We have even less data on Feraheme...

Tony

Tony
Can't speak to Feraheme, but this is for Sirinium, the constast agent for Combidex.
From an article you sent me over 3 years ago.

Clinical trials have also documented the safety of this agent9,11 with the most common side effect being back pain, occurring in about 3-6% of patients; this is of uncertain origin and usually resolves when the infusion is temporarily ceased. Other less commonly reported minor side effects are a rash, transient decrease in blood pressure, and headache.

Thanks John,
But none of this is convincing enough to do the scan at least for me. I know a small number of doctors and a lot of advocates that would disagree with me, but none have ever proven the claims. The Feraheme scans I posted on above show far more SE's than what Combidex showed. As far as allergic reactions, they are what they are and it's a shame they didn't check for it prior to giving it to the patient. It is rare, I understand, but interestingly, the studies I did see in Europe only had a small number of patients (less than 400) in it. If one man died in that study due to anaphylactic shock then that's a bad trial result. I do know that there were not thousands of PCa survivors that went to Holland and had this scan. Only those that could afford it went there. Trips to Europe are not cheap so even if the scan was inexpensive the average Joe probably didn't go.

Here is the best write up on Combidex and it includes data on Feraheme but its by a well known advocate and not a doctor:
www.ustoowichita.org/pdf/COMBIDEX.pdf

Read the letters from Baerentz at the end and he clearly states that these tests still lack approval for diagnostics and that extensive research is lacking on the efficacy and it is a mandatory necessity...And if that's what HE is saying?

Every time we have this discussion I write to the folks I know in the business on where things are. I always want to find better options and if they get better data and say I'm wrong for being skeptical I'll be the first to admit it. So far the replies I have seen today are like me. Vogelzang said he is more friendly to scans to determine if a high risk case might benefit with surgery but not to try to track the cancer around the body because it won't likely change the treatment protocol. If we start radiating every lesion we find that's not hindering a patients QoL you will hinder the patients QoL with treatment side effects. When asked if we could ever start radiation to nodes when detected in small amounts he said we could but it is highly unlikely to any significant provide disease control. Instead pain management is the best use of scans and the F18 bone scan is more reliable to find bone mets for treatment with radiation once pain is present.

The common theory is if we continue to track and treat blips on an even slightly erratic radar what harm can be done to the patient? That answer is far more disturbing than what good we can prove today the value of that radar is...

Tony

Post Edited (TC-LasVegas) : 5/11/2012 3:31:38 PM (GMT-6)

Nellie,
I am a proponent of hope. And I understand the personal preference approach. But Feraheme is not a treatment at least for PCa and the benefits are what I'm questioning. I know some of the short term risks but not the long term risks.

PS: One of the respondents to my emails today stated that the current trials for Feraheme are about to be turned down by the FDA for high levels of false positives. The same thing is why the Choline trials have been stopped.

Ugh!

ASCO is around the corner and we'll get an update I understand...

Tony

BB_Fan,
Your T levels are pretty much in line with the way mine responded to ending HT. It took me a full year to get above 300. I just heard my T levels are 355 today and it hasn't stopped climbing since I stopped HT. If you're like me you're probably feeling pretty good right now...


Tony

Tony, you are absolutely right. I am feeling great right now. Almost fully back from HT. Just need to build up some move muscle and take off a few pounds. At this point I'm just being lazy about it. My treatments have worked out very well for me so far, and I'm starting to feel much more optimistic about the future. BB

To me, the issue is whether the scans are accurate and if radiation can kill small metastatic lesions without significant collateral damage.  In my experience as a pharmacist, feraheme injected one time has little risk especially in the light of what it is being used for.  I have followed hundreds of dialysis patients that have received higher doses more often.

Paul

Post Edited (PDL17) : 5/12/2012 2:25:10 PM (GMT-6)

Wow! Arnie said that you would come through! Thanks so much for ALL the input.  It is so comforting to hear from all of you. We are anxious to hear about any and all imaging that may be available. We were ready to go to Sandlake but couldn't have the imaging .... so we will glean from all of this excellent info! and move forward with hopes for cure..... hugs