Xofigo + Zytiga Before Chemo in Asymptomatic Patients

Dr. Fabio AlmeidaIn the November 2014 issue of Prostate Forum, we featured conversations with Dr. Fritz Schroder, Professor Emeritus of Erasmus University and Dr. Fabio Almeida of the Southwest PET/CT Institute.

Here’s the interview with Dr. Almeida!

Next month we’re featuring conversations with Dr. Eugene Kwon about the development of immunotherapy for prostate cancer and ogliometastatic disease.

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Dr. Fabio Almeida, of Southwest PET/CT Institute, is currently enrolling patients in a new trial on Xofigo and Zytiga in men with metastatic castration resistant prostate cancer. Prostate Forum recently spoke with Dr. Almeida about the trial’s design and end- points, as well as which type of patient is eligible to participate.

PROSTATE FORUM: Can you walk us through the trial’s design?

FABIO ALMEIDA: Our trial looks at the time to skeletal systematic events (SSEs) in patients with metastatic castration-resistant prostate cancer with a rising PSA on a combination of Xofigo and Zytiga. (Zytiga is usually given along with Prednisone.)

We’ll enrolling about 800 patients.

We have a placebo arm. The trial is randomized one-to-one. Half the patients will get Zytiga +Prednisone and Xofigo; the other half will get simply Zytiga +Prednisone.

Our goal is to see if the combination of Xofigo and Zytiga + Prednisone can cause a delay in symptomatic skeletal events-i.e. painful skeletal metastasis, fractures, the need for radiotherapy, etc.

How is this trial different from previous trials on Xofigo?

The main difference between this trial and what has been done thus far with Xofigo is that we’re looking at patients who are asymptomatic, or minimally symptomatic. In other trials looking at the combination of Xofigo and Zytiga + Predisone, patients had to be symptomatic and taking some form of pain medication—over-the-counter at least—to qualify. That is true for both the clinical trials as well as commercially available Xofigo.

I think what is really exciting about the trial is access to Xofigo in combination therapy at an earlier stage when patients have not seen any other therapy, so that there is a lower burden of bone metastasis. It makes sense to not just hit the cancer through bone physiology, but also through a mechanism that we know works directly to treat it.

We are one of the few places already open for this trial. Other centers in the country are certainly trying to open the trial, but we were the first to enroll patients.

Who is eligible to enroll?

Men who are: castrate resistant (i.e. they have a testosterone less than 50 with a rising PSA); have 2 or more bone metastases; no lung, liver, or other soft tissue metastases; no previous chemotherapy; no previous Zytiga (abiraterone); no previous Xofigo or Samarium; little or no cancer pain; and no atrial fibrillation, Crohn’s disease, or ulcerative colitis.

Patients will have received some form of hormonal therapy?

Yes, by definition, if a man is castrate resistant he either had a prior orchiectomy or he has a rising PSA while on Androgen Deprivation Therapy. (If someone has a rising PSA and they’re not on hormonal therapy, then they’re not castrate resistant.)

Does the trial cover all treatments (Xofigo and Zytiga) and the imaging tests you’ll be using?

Yes, we pay for all the imaging. The Zytiga + Prednisone and Xofigo are certainly covered. All laboratories are covered. There is even a small travel stipend for each clinic visit. This is a long- term study, so we are looking to follow patients for at least seven years, or I should say maximally seven years. We do expect some patients will, in this particular category, develop skeletal related events or other secondary end-points within a few years. Perhaps they will leave the trial once they reach one of those endpoints.

Xofigo is a fairly rigorous program in that it involves 6 months of treatment. Since patients have to come to our center for this treatment, they have to be able to travel. The actual procedure for Xofigo, as I’m sure your readers know from other interviews, is very straightforward, but has to be done in very specific places.

How often would patients have to visit you?

For the first 3 months of treatment, they need to come every 2 weeks. Only once a month for the actual treatment, but there is a clinic follow-up visit for laboratories and vital signs every 2-weeks in between the therapy for the first 3 months. After that, for the following 3 months, they need to come once a month.

If a man would like additional information on the trial, whom should he contact?

First, interested patients can read more about the trial at http://www.swpetct.com/clinical-trials.

Our clinical research coordinator, Elisa Blackwell, is the person to contact about qualifications and logistics. Her phone number is 602-331- 1771.

Currently, the trial is open at our Tucson location, which is a little over 100 miles south of Phoenix. We are hoping to open the trial at our Phoenix location as well sometime either by the end of 2014 or early 2015. (Phoenix is easier for patients traveling from out-of-state.)

 

 


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