Newswire (Published: Thursday, September 26, 2019, 7:11:00 AM CDT, Received: Thursday, September 26, 2019, 7:51:21 AM CDT)

Word Count: 630

Stephenson Cancer Center at OU Medicine recently launched a clinical trial testing an immunotherapy drug for men who are on active surveillance.

Men who are diagnosed with low-risk prostate cancer usually opt for active surveillance a monitoring of their cancer over time without undergoing treatments that would cause side effects. In many men, the cancer never grows and poses no threat, but in others, the cancer begins to grow and treatment is necessary.

The hope is that the drug which uses the patients own immune cells and doesnt cause side effects will attack and eliminate the cancer or keep it from changing over time.

Were very excited about this clinical trial, said Dr. Kelly Stratton, Stephenson Cancer Center urologic oncologist who is leading the trial. We think its a valid way of helping patients who are on active surveillance. About a third of men who are on active surveillance will eventually need treatment for their cancer over time. Ultimately, were trying to prevent them from ever needing treatment.

The drug, called Provenge, already is approved by the Food and Drug Administration to treat metastatic prostate cancer. However, when the drug was first tested in patients, it worked best in men who had received earlier treatment of their prostate cancer. The next logical step in the research was to study how Provenge affected cancer over time in low-risk patients.

In the clinical trial, men who are randomized to receive Provenge will have their blood drawn, just as if they were donating blood. The immune cells are filtered out, and the rest of the blood is returned to the patient. The patients cells are then shipped to a company out of state, where they are infused with a molecule that provokes an immune response specific to prostate cancer, coupled with a growth factor that stimulates the cells to grow. The cells are shipped back to Stephenson Cancer Center in three days and given back to the patient like a blood transfusion.

Basically, its activating a persons cells against prostate cancer and prompting them to recognize the cancer, Stratton said. Once theyve been activated, our thought is that they will go to the prostate and either fight the cancer or keep it from growing.

Because Provenge uses the patients own cells, most patients have little to no side effects, Stratton said. The immune cells are not genetically altered, making the treatment safe and well tolerated.

Thats the whole point of active surveillance to minimize the risk of side effects that come with treatment like radiation therapy, he said. With Provenge, were not manipulating the cells were only doing what would happen naturally if the cells were to recognize prostate cancer.

If the clinical trial proves the drug to be successful in low-risk patients, it also will benefit patients mental outlook, Stratton said. Most patients appreciate active surveillance because they can avoid treatment, but it can also lead to an unsettling feeling of not doing anything to keep the cancer in check, he said.

Patients love the idea of active surveillance, but theres also a natural feeling of wanting to do something to address the cancer, he said. We think this drug is something that will activate their immune system against the cancer, but their quality of life will stay the same.

Urologic oncologist Dr. Michael Cookson, chairman of the Department of Urology at the OU College of Medicine, said the Provenge trial is unique in offering men without symptoms of their prostate cancer the opportunity to see if their immune system can further reduce the risk of the cancer progressing.

Weve made major contributions to national clinical trials with our prostate cancer patients, who are brave and willing to allow us to try to move the science forward, Cookson said.

Companies

Ou Medicine Inc.

Industries

Healthcare
      Healthcare Facilities
            Cancer Centers
Biotechnology
      Biopharmaceuticals
            Immunotherapeutics
Pharmaceuticals
      Biopharmaceuticals
            Immunotherapeutics

Subjects

Health and Wellness
      Medical Conditions and Diseases
            Cancer
                  Prostate Cancer
            Men's Health Issues
                  Prostate Cancer
            Urological Diseases
      Medical Specialties and Practices
            Urology
      Medical and Pharmaceutical Regulation
            Drug and Device Approval Process
                  Clinical Trial Events
                        Approval and Initiation of Clinical Trials
                  Drug Testing and Approval Process
                        FDA Drug Approval
      Treatments and Therapies
            Medicinal Drugs
                  Drug Testing and Approval Process
                        FDA Drug Approval
            Growth Factors and Cytokines
Trading Impact
      Drug and Device Regulatory Impact
            Clinical Trial Events
                  Approval and Initiation of Clinical Trials
Politics and Government
      Government Agencies (U.S.)
            Department of Health and Human Services
                  Food and Drug Administration