Combidex going away

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don826
Veteran Member


Date Joined May 2008
Total Posts : 1010
   Posted 8/12/2009 10:23 PM (GMT -6)   
I read on another PCa site that the company (AMAG ?)that makes the Combidex fluid will cease or has ceased to manufacture it. So it looks like the test will not be available in Holland or the US. 
 
Don 
Diagnosed 04/10/08 Age 58 at the time
Gleason 4 + 3
DRE palpable tumor on left side
100% of 12 cores positive for PCa range 35% to 85%
Bone scan clear and chest x ray clear
CT scan shows potential lymph node involvement in pelvic region
Started Casodex on May 2 and stopped on June 1, 2008
Lupron injection on May 15 and every four months for next two years
Started IMRT/IGRT on July 10, 2008. 45 treatments scheduled
First 25 to be full pelvic for a total dose of 45 Gray to lymph nodes.
Last 20 to prostate only. Total dose to prostate 81 Gray.
Completed IMRT/IGRT 09/11/08.
PSA 02/08 21.5 at diagnosis
PSA 07/08 .82 after 8 wks of hormones
PSA 10/08 .642 one month after completion of IMRT, 6 months hormone
PSA 03/09 .38 six months post radiation and nine months into hormones 
PSA 06/09 .36 or .30 depending on who did the test
 
 
 


Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 8/13/2009 9:11 AM (GMT -6)   
Don,
I can't find anything that supports this information. In the latest press releases by Advanced Magnetics Inc. (AMAG) I read where the FDA has approved a fast track for the contrast. If something better is on the horizon for AMAG then I could understand but nothing has been announced. If you can please forward what you saw and I will bring it to my advocacy friends and see what they have heard. The only negative I have heard is that Combidex has led to false positive detections in lymph nodes in up to as much as 25% of cases. But that is not necessarily a bad news item. Once a node is suspected to be positive in the imaging, then biopsy with less invasive needles is possible to verify the imaging.

Tony
 Age 47 (44 when Dx)
Pre-op PSA was 19.8 : Surgery at The City of Hope on February 16, 2007
Geason 4+3=7, Stage pT3b, N0, Mx
Positive Margins (PM), Extra Prostatic Extension (EPE) : Bilateral Seminal vesicle invasion (SVI)
HT began in May, '07 with Lupron and Casodex 50mg (2 Year ADT)
IMRT radiation for 38 Treatments ending August 3, '07
Current PSA (May 11, 2009): <0.1
 
My Journal is at Tony's Blog  
 
STAY POSITIVE!


John T
Veteran Member


Date Joined Nov 2008
Total Posts : 4269
   Posted 8/13/2009 11:25 AM (GMT -6)   
Tony,
The false positives are really not that bad if read by an expert. Each node is graded on a 5 level grade as to suspicion. The grade level along with the location of the node is taken into account in the overall diagnosis. I had one node with a low suspicion level and because all node around it were clear it was determined that it was also clear. PC follows a definate path through the lymphatic system and if only one node at the end of the path shows positive it is highly unlikely that that node would be infected. As in any scan or test it takes interpertation by an expert. You get an overall probability of involvement or non involvement that is pretty accurrate. If a node shows clear there is only a 4% chance that it is positive.
You are correct in that a biopsy can be taken of the suspected nodes which is a less invasive procedure than surgical removal.
JohnT

64 years old.

PSA rising for 10 years to 40, free psa 10-15. Had 5 urologists, 12 biopsies and MRIS all neg. Doctors DX BPH and continue to get biopsies yearly. Positive Biopsy in 10-08, 2 cores of 25, G6 less than 5%. Scheduled Surgery as recommended.

2nd Opinion from Dr Sholtz, an Oncologist said DX wrong, path shows indolant cancer, but psa history indicates large cancer or metastasis. Futher tests and Color Doppler confirmed large transition zone tumor that 13 biopsies and MRIS missed. G 4+3 approx 2.5cm diameter.

Combidex MRI in Holland eliminated lymphnode mets. Casodex and Proscar reduced psa to 0.6 and prostate from 60mm to 32mm. Changed diet, no meat and dairy.

Seed implants on 5-19-09, 3 hours door to door, no pain, minor side affects are frequency and burining urination. Daily activities resumed day after implants.

Scheduled for 5 weeks IMRT in July

JohnT


don826
Veteran Member


Date Joined May 2008
Total Posts : 1010
   Posted 8/13/2009 12:11 PM (GMT -6)   
Hi Tony,
 
The posting was from an USToo member out of NJ on prostatepointers.org website. I did a search on the AMAG site and could find no reference to Combidex. I did find some older articles about US trials but nothing else that would confirm the posting. He also mentioned a Dr. Joseph Bender as the source of his information.
 
There was no information as to why it would be withdrawn. I suspect that without FDA approval it is not economically viable for the producer. All that I have read about it says it is effective. Personally, I was hoping to see it in the US at some point.
 
Don

John T
Veteran Member


Date Joined Nov 2008
Total Posts : 4269
   Posted 8/13/2009 2:17 PM (GMT -6)   
The contrast agent, Sirinum, made in France, is the exact same agent FDA approved for use in detecting liver cancer. The only difference is it is 20 nanos vs the Combidex which is either 2 or 5 nanos.
JohnT

64 years old.

PSA rising for 10 years to 40, free psa 10-15. Had 5 urologists, 12 biopsies and MRIS all neg. Doctors DX BPH and continue to get biopsies yearly. Positive Biopsy in 10-08, 2 cores of 25, G6 less than 5%. Scheduled Surgery as recommended.

2nd Opinion from Dr Sholtz, an Oncologist said DX wrong, path shows indolant cancer, but psa history indicates large cancer or metastasis. Futher tests and Color Doppler confirmed large transition zone tumor that 13 biopsies and MRIS missed. G 4+3 approx 2.5cm diameter.

Combidex MRI in Holland eliminated lymphnode mets. Casodex and Proscar reduced psa to 0.6 and prostate from 60mm to 32mm. Changed diet, no meat and dairy.

Seed implants on 5-19-09, 3 hours door to door, no pain, minor side affects are frequency and burining urination. Daily activities resumed day after implants.

Scheduled for 5 weeks IMRT in July

JohnT


Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 8/13/2009 9:08 PM (GMT -6)   
Don I get the PPML feeds veryday. Up to 50 or 60 sometimes. I have to admit I don't read them all. It's tough enough with my work in different groups to keep up with HealingWell. The beauty of each is that we share what we read. key points still get around. Thank you for the updates. I will keep an eye on the Combidex story. For now, I do know it is on a fast track with the FDA. If it changed then it likely changed for a good reason. Perhaps a better method of imaging. I will contact Mike at the InfoLink. He is the best I know at getting to the bottom of these things. Plus he owes me a dinner...I'll see him in D.C next month...

Tony
 Age 47 (44 when Dx)
Pre-op PSA was 19.8 : Surgery at The City of Hope on February 16, 2007
Geason 4+3=7, Stage pT3b, N0, Mx
Positive Margins (PM), Extra Prostatic Extension (EPE) : Bilateral Seminal vesicle invasion (SVI)
HT began in May, '07 with Lupron and Casodex 50mg (2 Year ADT)
IMRT radiation for 38 Treatments ending August 3, '07
Current PSA (May 11, 2009): <0.1
 
My Journal is at Tony's Blog  
 
STAY POSITIVE!

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