Credit: Karen Cimino Wilson
Shown here are Jennie Bridges (left), a medical laboratory technician and certified clinical research coordinator; Junior Kelly, 75, a patient; Karen Dziadziola, a registered nurse, CCRC and clinical research manager; and Dr. David Lipsitz, a physician and medical director of Carolina Clinical Trials.
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It was a double gut-punch, but Kelly decided to look forward and find a cure. He learned about an FDA-approved clinical trial for prostate cancer patients at Concord-based Carolina Clinical Trials and joined it.
Now Kelly?s Prostate Specific Antigen ? which indicates prostate cancer when it?s high ? is back down again and he?s on the road to recovery, says Dr. David Lipsitz, a physician and medical director of Carolina Clinical Trials, which is located at 1084 Vinehaven Drive NE in Concord just off Exit 60 on Interstate 85.
Kelly is one of hundreds of patients benefitting from the research at Carolina Clinical Trials, which now offers patients with prostate cancer access to more FDA-approved clinical trials than any other research center in the Carolinas.
The practice has six prostate cancer trials covering new treatments like androgen receptor antagonists, angiogenesis inhibitors and cancer vaccines. The trials are sponsored by pharmaceutical corporations including GTx, Medivation, and Nymox.
Currently, Carolina Clinical Trials has more prostate cancer trials than Duke University Health System and the Levine Cancer Institute combined. Duke has two clinical trials plus a third which is just a telephone survey testing educational materials, and Levine has two prostate cancer trials.
Lipsitz is a urologist who went to medical school in Colorado and did his residency at UNC-Chapel Hill. He started the Carolina Clinical Trial group in 1995 and since then has conducted hundreds of trials. Lipsitz also practices at Carolina Urology Partners, and shares space with their Concord branch.
?When I first got here, a lot of people were leaving town for the trials,? Lipsitz said. ?We worked really hard to get these trials here. Right now there?s nobody in the state who has as many cancer trials as us.?
In addition to the cancer trials, Carolina Clinical Trials also does trials for overactive bladders, enlarged prostates, incontinence and erectile dysfunction. Prostate cancer trials tend to be the most difficult to set up because of the difficulty of finding patients who have the condition and meet other criteria for eligibility. They also must be in the right stage of treatment for the trial.
Lipsitz leads the planning and does much of the skilled work of examining patients and interpreting results, but he?s assisted by two other physicians, Richard Natale II and Joseph Debord, and two research coordinators, Jennie Bridges and Karen Dziadziola. Bridges and Dziadziola do a lot of the front-line work, collecting data, managing regulatory compliance, administering treatments, and shepherding patients through the process.
In general, clinical research begins when a sponsor - generally a pharmaceutical company - has developed a new medicine or treatment which might be more effective than the existing options. That sponsor then lays out a protocol for testing the drug and gains approval from the FDA. To actually do the research, the company finds research groups who will find and enroll patients in the appropriate stages of the disease, treat them with the medicine being studied, and collect data on the results. If the data shows that the treatment is actually effective, the sponsor then submits it to the FDA to win approval for the treatment in the United States.
Lipsitz said he typically has 100 to 500 patients enrolled in trials. All of the patients volunteer to participate. Cancer trials typically include between 10 and 12 patients each. Lipsitz said none of the cancer trials he is conducting include placebos.
?Usually, by the time we get a trial, they are in the early development phase,? Lipsitz said.
?Once it gets to us, it?s not does it work, it?s how well does it work,? said Neil Quinn, Technology and Marketing Coordinator for Carolina Clinical Trials.
Lipsitz said he wanted to bring the trials to Cabarrus County to make cutting-edge care more accessible to local patients. He said often patients he works with are of advanced age and traveling to other trial locations in Charlotte or the Research Triangle can be difficult.
?Every person should have access to trials,? he said. We wanted to offer the people of Concord and the surrounding area the same care you would get in an academic area.?
? Kelly said that participating in the clinical trial has helped him. Trial participants get their treatment for free and are also compensated for their time and transportation costs. Cancer treatment can be expensive. One of the newest prostate cancer drugs - Provenge ? costs $100,000 for three injections.
But Kelly said cost is not what mattered most to him. He wanted to avoid surgery because he said at his age recovery from surgery can be difficult. But he also likes the idea of helping future generations. The study Kelly participated in involved looking at whether an existing drug works as well when injected into a muscle as it does when injected subcutaneously. Kelly has had his last treatment.
When asked if Kelly is cured, Lipsitz said, ?I say you?re cured, but we?re going to follow you.?
Carolina Clinical Trials current prostate cancer trials are:
BNIT-PRV-301 (BN ImmunoTherapeutics) : A Phase 3 Efficacy Study of a Recombinant Vaccinia Virus Vaccine to Treat Metastatic Prostate Cancer (Prospect)
10TASQ10 (Active Biotech): A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer
MDV3100-09 (Medivation) : Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer (STRIVE)
G200712 (GTx) : Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer
NX03-0040 (Nymox): Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
000008 (Ferring) : Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer (IM1).
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