“You really need to know what you need to do in terms of all the paperwork, and there are a lot of things that need to be done to run a clinical trial, and if you don’t do them right, you’re not going to get more studies,” Zanin said. The way that the clinical trials program is set up now, there is very little overhead cost, the physicians are in touch with Clinical Research Solutions every day, and SouthWest is satisfied with the way the program is running.
SouthWest is satisfied with the way the program is running. SouthWest has what Gervasi described as a very active clinical trials program. He said the practice is currently recruiting patients for 12 to 14 clinical trials. A number of them are for prostate cancer, but there are also trials in benign prostatic hyperplasia and overactive bladder. “What’s helpful is that this also extends a lot of opportunities to patients who may not be candidates for FDA-approved drugs for prostate cancer because their disease is not advanced enough, so these are people we’ll consider for a trial so they can be treated with some kind of medication rather than waiting until they have metastatic disease,” Gervasi said.
The trials with which they are currently involved are intended to show how well oral drugs are going to work for patients with early stage prostate cancer. “We just got approved for a trial using one of the PARP inhibitors for prostate cancer, so I think that’s another exciting new area for a drug class that’s been approved for ovarian cancer, and now it’s being looked at in the area of prostate cancer,” Gervasi said.
Prostate Cancer Clinic
SouthWest’s prostate cancer clinic began as a clinic for patients with prostate cancer who received treatments that affected their bone health. Doctors in the clinic would make sure that patients were taking their medications and getting their vitamins, scans, and imaging. Over time, the program evolved into an advanced prostate cancer clinic.
As more medications and treatments become available, SouthWest hopes to add these to its drug armamentarium in order to retain the patients under its care and attract new ones. “What happens is when people get to the point where they have advanced prostate cancer, they’ve already been at our practice for possibly many years, so they’re very comfortable with us; they’re very satisfied with the care and they don’t like to leave the practice, so that’s why it’s nice to be able to offer these treatments right here at our practice where they feel comfortable,” Gervasi adds.
The broader range of therapies has made the treatment of prostate cancer more optimistic, he added. “There are all these new therapies that were not available about 6 years ago; there’s also drugs for bone health that we give, and all these are available to the patients, which really gives them more hope than they had just a few years ago. All of these improve overall survival, so patients are happy to hear this, and it’s a very good atmosphere for patients with advanced prostate cancer,” Gervasi said.
SouthWest recently started offering MRI fusion biopsies for the patients, as other large practices are doing. MRI of the prostate and MRI fusion biopsies are newer procedures that help determine whether a patient would be placed on active surveillance or not. These tests combined with genomic testing are helpful to discern how aggressive a patient’s prostate cancer is and to determine how aggressive the therapy should be.
Just a few years ago, there was a lot of debate within the practice a few years ago about whether they should utilize this new technology. According to Zanin, the issue was that they would not be compensated for MRI fusion biopsies, and the cost was over $100,000 for the equipment. “You have to look at things from a business standpoint, because no money, no mission,” Zanin said. Although the practice could not bill payers for MRI fusion biopsies, patients were asking about the procedure, and finally everyone in the practice decided they needed to make these tests available. “We found a way around things to do it at the hospital, which is good, but the next step is to bring it under our domain,” Zanin said.