Since 1988, when the U.S. Food and Drug Administration approved proton therapy to treat cancer patients, the medical community has been conducting clinical trials to investigate the use of protons in treating different types of cancer. Over the years, many patients have volunteered to take part in these clinical trials to help find improvements in fighting cancer with proton therapy.
As a dedicated provider of proton therapy, ProCure is always looking for ways to improve the lives of our patients with cancer. Our team has made a commitment to participate in clinical trials to further our knowledge of the benefits of proton therapy in treating many tumor types. In addition, ProCure continues to pioneer advancements in the use of proton therapy for treating cancer and other diseases.
What Are Clinical Trials?
Clinical trials are research studies that involve people. They are the final step in a long process that begins with research in a lab. Each study answers a specific set of scientific questions and explores better ways to prevent, screen for, diagnose, or treat a disease. Most cancer treatments used today are the results of past clinical trials. To better understand cancer clinical trials, please visit, About Clinical Trials
What Are Protocols?
For every clinical trial, a protocol, or action plan, is prepared prior to conducting the trial. The protocol describes in detail what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. For instance, some studies need patients with a certain condition, some need healthy people, or some need just men or just women.
Clinical Trials at this ProCure Center
- 11-497/NCT01617161: Stage I/II Prostate Cancer (PARTIQol Study, 3.2015)
For men who have been diagnosed with Stage 1 or 2 prostate cancer and who are considering radiation therapy to treat their disease, there is a clinical trial being conducted at the ProCure Proton Therapy Center, Somerset, NJ, for you to consider.
This trial is supported by NCI and compares two types of radiation therapy for prostate cancer: intensity-modulated radiation therapy (IMRT) and proton beam therapy (PBT). Both methods are already approved by the Food and Drug Administration (FDA) to treat prostate cancer, but there has not yet been a clinical trial to compare which of these two radiation types has the fewest side effects on bowel, urinary, and erectile function. Proton beam treatment is available at the ProCure Proton Center in Somerset, and traditional IMRT is available at CentraState Medical Center in Freehold, NJ.
This trial seeks to enroll 400 men. We hope to enroll patients who represent the diversity of the men who are diagnosed with prostate cancer. Trial participants will be randomly assigned to receive either V. 4-11-14 (NCI) IMRT or PBT over a 9-week period, and they will be followed closely for up to 5 years after the completion of treatment.
To learn more about this research study and to see if you are eligible, please call to schedule a consultation at 732-357-2600.
You can also find information online at http://1.usa.gov/16hZGMt
- PPCR/NCT01696721: A Multi Center Registry of Pediatric Patients treated with Proton Radiation Therapy
The objectives of the study are to establish a Registry of pediatric patients treated with proton radiation therapy in the United States, describe the patterns of care for pediatric patients receiving proton radiation therapy, describe the patterns of follow-up at proton facilities where patients are often referred from a significant distance and from centers of excellence and to describe the acute and late effects in pediatric patients treated with proton radiotherapy.
All pediatric patients who are treated with protons will be eligible to participate. The estimated accrual is 5,000 patients in 10 years in all participating sites.
Study is coordinated by Massachusetts General Hospitals/Dana-Farber/Harvard Cancer Center
- PCG REG001-09/NCT01255748: Patients Treated with Proton Therapy
A registry trial to collect and analyze information from patients treated with proton therapy.
- PCG BRE008-12/NCT01758445: Stage II/III Breast Cancer
A study to look at the rates of acute and long-term adverse events of postoperative proton radiotherapy for complex loco-regional irradiation in women with loco-regionally advanced breast cancer. This study specifically includes longitudinal follow-up to assess the incidence of cardiac mortality and second malignant neoplasms at 10 and 15 years following proton therapy.
- PCG LUN005-12: A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer
A research study to compare the effects (good and bad) on subjects and their cancer using standard chemotherapy in combination with hypofractionated proton radiation therapy. Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.
How Can I Find Clinical Trials?
You can search for more clinical trials by visiting http://www.clinicaltrials.gov
How Can I Participate in a Clinical Trial?
If you are interested in participating in a trial listed above, please contact a member of our research team and we will help you with next steps.
New Jersey/Metro New York Heba Darwish, Clinical Research Manager
Phone: (732) 357-2676
Email address: firstname.lastname@example.org