The exciting thing about Provenge is not only the real survival advantage that it offers with minimal side effects, but that it is a proof of concept treatment that is heralding in the potential future of many other immunotherapies. Today, we have two new possible treatments in active phase 3 trials, Prostvac and Yervoy. If you search this blog you will find a number of discussions about both these investigational treatments as well as a very comprehensive teleconference (with both audio and a written transcript) at: http://malecare.org/teleconferences/.

All of the current research about the use of immunotherapy has been focused on men with advanced prostate cancer (men with castrate resistant metastatic prostate cancer). A new trial is beginning at Johns Hopkins University (JHU) which is designed to move the potential of immunotherapy to an earlier prostate cancer disease state, men who are ready to have primary treatment.

This new trial is a randomized Phase I/II study for men with medium and high-risk prostate cancer who are planning on surgery. Men need to be eligible for surgery at JHU, that is they must not have metastatic disease and have to be in reasonable physical condition.

The trial is designed to use immunotherapy to hopefully cut the risk of recurrence. So men will receive one of two treatments intended to activate the immune system prior to surgery. One group will get a 1 month dose of degarelix, which rapidly drops testosterone and induces a T cell infiltrate in the gland. This is sort of an auto-vaccination. This is interesting and important because degarelix has never been used in the neo-adjuvant setting before, although it’s FDA approved and generally well-tolerated.

The second arm gets a dose of GVAX prostate as a prime in addition to the degarelix acetate. The GVAX is also well-tolerated, although there’s a robust local inflammatory reaction and sometimes a bit of fever / chills overnight. That group also gets a very low dose of cyclophosphamide to deplete regulatory T cells 24 hours prior to the GVAX. That’s important because our studies show that GVAX works much, much better when preceded by a low dose of cyclophosphamide.

The trial is on appears on the United States government clinical trials web site at:

http://www.clinicaltrials.gov/ct2/show/NCT01696877?term=antonarakis&rank=1

If you might be interested you will be seen by one of JHU world class surgeons, Dr’s Alan Partin, Ashley Ross or Ted Schaeffer. However, if you have not yet settled on surgery, but might be interested in the trials if you do go the direction of surgery it’s best to come in through JHU’s multi-D clinic. If they want to be seen in Multi-D, you can contact the coordinator, Marian Raben at:

https://web.archive.org/web/20140515021122/http://www.hopkinsmedicine.org:80/kimmel_cancer_center/centers/prostate_cancer/prostate_multi_d_clinic.html

Those who might be interested in the trial but want to do have a little scientific understanding about the proposed treatment you can go to the following two published papers at:

https://mail-attachment.googleusercontent.com/attachment/u/0/?ui=2&ik=966e1bac94&view=att&th=140307c6f277af9e&attid=0.1&disp=inline&safe=1&zw&saduie=AG9B_P8Udaa0nay_1NxNQHELu0OA&sadet=1376918786584&sads=j1-0B7jujPo2ylwetY1t-6Tpk9o

https://mail-attachment.googleusercontent.com/attachment/u/0/?ui=2&ik=966e1bac94&view=att&th=140307c6f277af9e&attid=0.2&disp=inline&safe=1&zw&saduie=AG9B_P8Udaa0nay_1NxNQHELu0OA&sadet=1376918936190&sads=zDjqL_bbKAEt2QgKGNjrC33n9tc

Note that in the Wada paper (the first link), figure 3B tells the story, a little dose of cyclophosphamide really helps the GVAX to function.

Joel T Nowak, M.A., M.S.W.