What Could Emerging Prostate Cancer Research Mean for Patients?

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Topics include: Treatments

At the 2015 American Society of Clinical Oncology (ASCO) meeting in Chicago, cancer experts met to discuss developing cancer research.  Dr. Neal Shore, a leading specialist, shared his perspective on prostate cancer news from the conference and the many studies currently underway.

Sponsored by the Patient Empowerment Network through an educational grant from Sanofi Oncology and an independent educational grant from Astellas and Medivation, Inc.

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Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.      

Andrew Schorr: 

Hello and welcome. I’m Andrew Schorr.

Every year, cancer experts from around the world gather at the American Society of Clinical Oncology meeting, the ASCO meeting, in Chicago. And, of course, we attended. And at the recent meeting, they were discussing a lot about prostate cancer. We follow advanced prostate cancer very carefully, and a regular guest is an expert, Dr. Neal Shore, no relation.

We asked Dr. Shore about  the latest results, including the STRIDE trial, where they’re studying how to combine and sequence treatments.

Dr. Shore:             

So we’re always fascinated by combinatorial therapies.  And we’ve had the great fortune of five new approved therapies in the CRPC landscape.  So there are lots of new options for our patients.  One of the most often asked questions is, “How do I sequence these approved therapies?” or “How do I combine them?” 

In the STRIDE trial, we took sipuleucel-T, also known as PROVENGE®, and we randomized approximately 38 patients; half to receive enzalutamide (XTANDI®) concomitantly with receiving PROVENGE, sipuleucel-T and the other half to receive their enzalutamide, also known as XTANDI, a few weeks just after completing a course of PROVENGE to see if that had any impact on the immunological parameters; immunoglobulin effects.  And more importantly, the ability to manufacture sipuleucel-T, also known as PROVENGE. 

And what we found was that it was perfectly fine in terms of manufacturing the PROVENGE; that enzalutamide had no adverse effects in terms of the manufacturing in either the concomitant arm or the sequential arm.  Now we’re following these patients long-term for final efficacy.  But what we’ve been able to show is take two approved therapies that improve survival in our CRPC patients and use them in a combinatorial fashion, and then very shortly thereafter in sequencing.

Andrew Schorr:                  

Dr. Shore also shared his perspective with us on the ARAMIS trial, which is investigating an oral inhibitor for prostate cancer.

Dr. Shore:             

So the ARAMIS trial is a molecule that’s being studied known as ODM-201.  It’s a very interesting androgen receptor signaling inhibitor oral molecule that’s now being studied in a big Phase III global trial looking at the M0 CRC population.  And there will be a randomization to a control placebo prospective study; large numbers, many sites throughout the world. 

And what we’re trying to do is demonstrate that ODM-201, an androgen receptor signaling inhibitor, which is a markedly different chemical structure from pre-existing androgen receptor signaling inhibitors.  We think it may have a better tolerability profile.  We think it may be more potent.  And it’s now in a registrational pathway in the M0 CRC space with the end point being metastatic progression-free survival.  So going from no radiographic evidence of disease despite a PSA up, testosterone down, and demonstrating that it delays radiographic progression.

Andrew Schorr:                  

Dr. Shore also shared with us his perspective on the Phase II results of the TERRAIN trial and its implications for men with castrate-resistant prostate cancer.

Dr. Shore:             

So the TERRAIN trial; myself and Axel Heidenreich from Germany, we were the CPIs for this global trial.  It was a large Phase II, 375 patient, trial.  And it was a head-to-head trial of enzalutamide versus bicalutamide (CASODEX®) for patients with either asymptomatic or minimally symptomatic M1 CRPC.  And the results of the trial very nicely show that progression-free survival at the median was improved by 10 months for the patients on enzalutamide versus bicalutamide with a hazard ratio of .44. 

We also looked at PSA declinations and quality of life.  And it significantly favored the enzalutamide arm.  Looking at adverse events, no new signals compared to large Phase III trials that we already had with enzalutamide known as the PREVAIL post-chemotherapy trial.  Sorry, the pre-chemotherapy trial and the AFFIRM post-chemotherapy trial.  So no new safety signals.  But, obviously, in a head-to-head, which we’ve rarely seen, clearly besting an earlier generation androgen receptor inhibitor, bicalutamide, both in terms of delaying radiographic progression as well as its impact on PSA and a FACT-P score with subscale evaluations.

Andrew Schorr:                  

Finally, with all of this developing research, we asked Dr. Shore to explain what it means for men with advanced prostate cancer.

Dr. Shore:             

So I think starting at the very beginning when we need to be more judicious in deciding who to biopsy at the right time.  There are many new markers out there that are helping to better inform us who to perform a biopsy on.  There are new assays and markers to decide if I’ve had a negative biopsy, should I have a repeat biopsy?  And then, finally, there are new markers that help better inform us if we’re diagnosed with prostate cancer, do I need to treat it aggressively with intervention or maybe monitor it with active surveillance? 

For our patients who subsequently do have an interventional therapy, whether it’s surgical or radiation or some form of a blade of therapy and we aren’t able to cure them, the tremendous excitement  now has been with the new approvals of oral agents, novel hormonal agents, radiopharmaceuticals in the form of radium 223, chemotherapies. 

And now there are many additional immuno-therapeutics that are coming into our armamentarium.  The only one so far to be approved is sipuleucel-T, known as PROVENGE.  But I really do think in the upcoming years, we’ll see immunotherapy augment the advanced prostate cancer population and even the androgen-sensitive population. 

In addition to that, here at ASCO today, we’ve had tremendous excitement about the release of the STAMPEDE data, which really very nicely corroborates the wonderful work that Chris Sweeney did in the CHAARTED trial.  And in a nutshell for patients, it’s essentially showing that if you’re newly diagnosed and you’ve got advanced disease outside your prostate and of a particularly significant volume of disease, rather than just be started on a therapy to lower your testosterone level, by getting some up-front chemotherapy in the form of docetaxel, also known as TAXOTERE®, that the patients do remarkably better.  And for the most part, it’s very well tolerated. 

So this is truly game changing because the STAMPEDE data presented by Nick James corroborates the data from the CHAARTED that was Chris Sweeney’s pioneering work.  And so this is very important for worldwide treatment of patients who present with newly metastatic prostate cancer. 

Andrew Schorr:                   

Thanks to Dr. Neal Shore for his perspective on the latest news in prostate cancer from ASCO 2015. Be sure to be signed up for our Patient Power community, so you will always get the latest news for your condition. I’m Andrew Schorr.  Remember, knowledge can be the best medicine of all.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you. 

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Page last updated on July 1, 2015