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• Introduction

• Clinical Trial Resources - This covers Access to Investigational Drugs (Compassionate Use, expanded use, etc.). Find there also, background on clinical trials, clinical trial consortiums, and finding a clinical trial.

      Some specific drugs of interest to HRPC patients:

• Abiraterone acetate (CB7630). The available data from Phase I and Phase II trials are summarized in this paper. There are links to currently available clinical trials.  This drug is now into Phase III testing with a potential availability of 2012.

• Alpharadin (this is a link to the manufacturer's website) - a new radiopharmaceutical Radium 223 and emits alpha particles (helium nuclei) as opposed to the beta particle emitters like samarium or strontium.  Currently in phase II testing. Alpharadin is being developed for skeletal metastases in patients with late-stage, HRPC.
  Algeta is expecting to progress Alpharadin to pivotal Phase III clinical studies in 2008 based on positive Phase II data, which show that it delays the progress of prostate cancer and reduces the extent and effect of metastasis. 

• Atrasentan (ABT – 627) Phase III clinical trials are running to evaluate this drug that may delay progression of bone metastases and reduce pain. The new name is Xinlay™.

• COX-2 Inhibitors(and NSAIDS). Off-label use.

• Sulindac (clinoril) This is a possible interim approach while the drug Aptosyn finishes clinical trials and gets FDA approval. Off-label use.

• Exisulind(Aptosyn). Development of this drug has likely been discontinued.

• Ixempra (Ixabepilone).  This is a Bristol-Myers-Squibb chemotherapy drug approved for advanced breast cancer and being tested in HRPC patients. It is a semi-synthetic analog of Epothilone B. The epothilones are a class of non-taxane microtubule-stabilizing agents. Bill Aishman wrote a paper in 2003 about this drug's development - before the results of various HRPC clinical trials were published, see "Epothilone B, A New, Effective Chemotherapy Drug for Advanced Prostate Cancer in Our Lifetime?"

• MoAbs - A Personal Experience With a Targeted Chemotherapy Clinical Trial

• Noscapine - This is an over-the-counter cough suppressant that has show in vivo that it is an anti-PCa agent.  The PCREF organization is working to bring this into testing with patients (see the Noscapine website). 7 March 2007.

• Phenoxodiol, a synthetic anticancer drug analog of genestein currently being tested for ovarian cancer. There has been one trial in HRPC patients that showed lots of promise.

• Quadramet (Samarium) with a Vaccine. The official title of this phase 2.5 clinical trial is: "A Randomized Phase 2.5 Study of 153Sm-EDTMP (Quadramet) With or Without a PSA/TRICOM Vaccine in Men With Androgen-Insensitive Metastatic Prostate Cancer
  NCI-07-C-0106."  The rationale for this combination is that the PROSTVAC-V/TRICOM vaccine has been shown to be safe and to have some preliminary activity plus there have been pre-clinical studies suggesting that there is synergy between Quadramet and immunotherapy (see abstract #4398, 97th AACR Annual Meeting, April 1-5, 2006.).  Prior taxotere use allowed. Bone metastases required, but no soft tissue disease. Arm I:
  Patients receive 153Sm-EDTMP IV over one minute on Day 8
  Treatment with 153Sm-EDTMP will be repeated every 12 weeks if there is adequate hematologic recovery
  Arm II:
  Patients receive PROSTAC-V/TRICOM (vaccine) subcutaneously on Day 1
  Patients receive 153Sm-EDTMP IV over one minute on Day 8
  Treatment with 153Sm-EDTMP will be repeated every 12 weeks if there is adequate hematologic recovery
  Patients receive PROSTVAC-F/TRICOM (fowlpox) subcutaneously on Days 15, 29, and then every 4 weeks
  Patients receive sargramostim (GM-CSF) subcutaneously daily for 4 consecutive days, beginning the day of each PROSTVAC vaccination
   

• Satraplatin(JM-216).  Withdrawn, failed phase III Sparc - median survival no better than prednisone alone. Satraplatin is being developed as a second-line chemotherapy for HRPC patients.  See the news release from 23 February 2007, entitled, "Satraplatin Shown to Significantly Reduce Risk of Disease Progression in Advanced Hormone-Refractory Prostate Cancer Patients." 

• Vaccines, includes a personal account of the Provenge vaccine trial.

• Valproic Acid (Depakote ER).  This drug is available "off label" for HRPC. Its use for HRPC isn't proven yet.

• Velcade. Velcade was also known as PS-341, MLN341 and LDP-341. It's generic designation is "Bortezomib" and it is a proteasome inhibitor. This paper, by Bill Aishman, is entitled, "Velcade: the Magic Bullet for Cancer?"

Introduction

For a list of "emerging therapies" and some information about them, visit the Us Too website page at

http://www.ustoo.org/Emerging_Treatments.asp

In this section we present our evaluations of various new and old therapies that may have some effect on HRPC. Keep in mind that we are not doctors—just patients who do our homework. We are trying to provide rational options that you can review with your oncologist.

We identify some of these therapies through our internet contacts and some through media announcements. It is our belief that there are also some answers out there in the medical literature that—for whatever reason—are not being pushed by the medical community or the pharmaceuticals. By sorting out these therapies we hope to help our medical teams by providing workable ideas for consideration.

Since there is some urgency to our search, we have established criteria that are meaningful to us as people living with HRPC:

• Is there hard evidence that this therapy has beneficial effects for humans with HRPC? We consider evidence to be published clinical studies in the recognized medical literature. Or it may be documented anecdotal evidence by people with no financial stake in the product. Pre-clinical studies (in vitro and in vivo with mice) rarely translate to successful drugs and even more rarely in fewer than 10 years.

• Is there hard evidence that this drug will not harm or kill the user? Simply put, if this one doesn’t work, will I survive to continue my fight?

• Is this drug available now (or within 12 months) for use? Tough question. But, if you can’t get it, it’s of no value in your fight against HRPC. However, it may be available in a trial or under compassionate use, so don’t write off a good prospect without trying.

Using these criteria, we have tried to provide a meaningful evaluation of new therapies so that you have the basis for a discussion of potential therapies with your oncologist. Each evaluation is reported in a similar format to help you compare alternatives.

None of us has any stake, financial or otherwise, in any of these therapies. We are all simply looking for the best answers available today for HRPC.

If you learn something of value as a result of using these evaluations, we will appreciate hearing from you so that we can continue to build this database of knowledge for everyone’s use.

Updated 8/6/2008 Howard Hansen

This information is provided for educational purposes only and does not replace or amend professional medical advice. Unless otherwise stated and credited, the content of www.hrpca.org is by and the opinion of and copyright © 2001-2008 by H. Hansen. All Rights Reserved.  Our policy regarding privacy,  right to reprint and contact information are at About Us. We are a 501(c)(3) not-for-profit public charity.