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Old 09-04-2010, 07:42 PM   #1
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Anyone with insight into Zometa and clinical trials?

Has anyone had experience with Zometa as an adjunct to hormone therapy? I was diagnosed 10 weeks ago with PSA of 23.9 and Gleason of 8. A bone scan and MRI indicated metastasis on my pelvic bone (no others were discovered). Two months of Lupron injections and daily bicalutamide have lowered my PSA to 1.9. I am 62, asymptomatic and in decent shape.

Iím being treated by a medical oncologist specializing in prostate cancer at a Comprehensive Cancer Center teaching hospital. In addition to my ongoing hormone therapy, he has offered me a place in a Phase III clinical trial designed to measure the effects on bone metastasis of early treatment with Zometa.

Has anyone on this board had experience with clinical trials or with Zometa? Iím still pretty new to this whole cancer business and would appreciate insights shared by members with experience in such matters.

This board has been a lifeline for me and I appreciate all the time and wisdom many members share each day.

 
Old 09-05-2010, 02:36 PM   #2
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Re: Anyone with insight into Zometa and clinical trials?

Hi again James,

I'll insert some comments in green. I've never been on Zometa, but I have been on one of the weaker bisphosphonates, Fosamax for most of my ten plus years as a survivor and more recently for a couple of years on Boniva. I have followed the involved issues fairly closely.


Has anyone had experience with Zometa as an adjunct to hormone therapy? I was diagnosed 10 weeks ago with PSA of 23.9 and Gleason of 8. A bone scan and MRI indicated metastasis on my pelvic bone (no others were discovered).

For my challenging case (first ever PSA 113.6 at age 56 in December 1999, GS 4+3=7, Stage 3, all biopsy cores positive, most 100% cancer, perineural invasion, but CT, bone and ProstaScint scans surprisingly essentially negative), I have been following recommendations of a number of doctors who are pioneering experts in hormonal therapy for prostate cancer. While they now prefer to use the milder bisphosphonates in most men on hormonal therapy, my strong impression is that they still are convinced Zometa is the drug of choice for men with established metastases. Not only is it good at maintaining and even rebuilding bone density, thereby countering one of the more serious side effects of hormonal therapy, but it also stabilizes, rolls back, or even eliminates bone metastases in a substantial proportion of patients. My impression is that use of Zometa is standard practice for these pioneering experts for patients with metastases. I can say with certainty, based on documented fact, that most of the oncologic community has taken years to catch on to the need to address threats to bone density for men on hormonal therapy. The experts were aware at least as early as 1999!

Two months of Lupron injections and daily bicalutamide have lowered my PSA to 1.9.

That's a decent reduction at this point, but you really want that PSA to drop at least to <0.05, and hopefully to <0.01. (I got to the latter twice before taking a vacation from the Lupron and Casodex (now bicalutamide) and continuing the finasteride as maintenance.) This third cycle, my lowerst PSA was 0.02, which happened two months after starting the vacation.)

Many doctors still remain unconvinced about the wisdom of adding a 5-alpha reductase inhibitor - either Avodart of finasteride - as the third leg of a triple hormonal blockade assault on the cancer, which is really sad. My strong impression, though as a layman, is that there is enough evidence to make triple blockade the go-to choice for most of us. I think the case is compelling for those of us with challenging cases.


I am 62, asymptomatic and in decent shape.

That's going to help. Exercise (aerobic and strength, with balance and flexibility also contributing) and diet/nutrition/supplement use are important in minimizing or warding off most important side effects of hormonal therapy. Many doctors prescribing hormonal blockade are unfortunately rather clueless about that! I hope yours is more savvy.

Iím being treated by a medical oncologist specializing in prostate cancer at a Comprehensive Cancer Center teaching hospital. In addition to my ongoing hormone therapy, he has offered me a place in a Phase III clinical trial designed to measure the effects on bone metastasis of early treatment with Zometa.

Has anyone on this board had experience with clinical trials or with Zometa? Iím still pretty new to this whole cancer business and would appreciate insights shared by members with experience in such matters.

I think adding Zometa is important, but I'm concerned about the trial aspect, unless it has to do with the dosing interval, where there are still important questions. If the trial randomizes you to either Zometa or another (much weaker) bisphosphonate or even a placebo, you would run a strong chance of being in an arm of the trial in which you did not get the Zometa. If it were me with your case characteristics, I would not settle for that; I would assertively request that I wanted treatment with Zometa and to heck with the trial. (This is from a guy who believes strongly in the value and role of clinical trial research, but I'm convinced the welfare of patients comes first.) On the other hand, if the trial randomizes you to various dosing intervals for Zometa, my impression is that so doing would not only benefit you but also serve to advance knowledge about the dosing interval.

This board has been a lifeline for me and I appreciate all the time and wisdom many members share each day.

I look forward to your sharing the valuable experience you are now accumulating.

Take care,

Jim

 
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