Clinical Trials

Spearheading World-Class Cancer Treatment

As a dedicated provider of proton therapy, ProCure is always looking to improve the lives of 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. With this participation, we continue 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.

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 for Proton Therapy
The U.S. Food and Drug Administration (FDA) approved proton therapy to treat cancer patients in 1988. Since then, 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.

Currently, ProCure is actively participating in 35 studies; in eight of these studies, we are the enrolling site. In addition, since inception, ProCure has published or been involved in approximately 125 peer-reviewed journal articles.

We work closely with various clinical trial sponsors, including Proton Collaborative Group (PCG), Federal Cooperative Group (NRG), Children’s Oncology Group (COG), Massachusetts General Hospital (MGH), St. Jude Children’s Research Hospital, National Cancer Institute (NCI) and Memorial Sloan Kettering (MSK).

Breast

PCG: BRE008-12 

Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Patients with Stage II/III, Loco-Regional, Non-Metastatic Breast Cancer Requiring Whole Breast or Chest Wall Irradiation with Lymph Node Irradiation

To determine 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 5, 10 and 15 years following proton therapy.

Principal Investigator: Henry Tsai, MD

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PCORI: RADCOMP RTOG-3510

Pragmatic Phase III Randomized Trial of Proton vs. Photon Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (Radcomp) Consortium Trial

To assess the effectiveness of proton vs. photon therapy in reducing major cardiovascular events, defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina).

Principal Investigator: Henry Tsai, MD

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Lung

PCG: LUN005-12

A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer

The purpose of this research study is 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.

Principal Investigator: Brian Chon, MD

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Pediatric Registry

MGH: Pediatric Proton Consortium Registry (PPCR) 12-103

Pediatric Proton Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients treated with Proton Radiation Therapy

The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using standard chemotherapy in combination with hypofractionated 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.

Principal Investigator: Jae Lee, MD 

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Prostate

Rectal Spacers Use in Prostate Cancer Radiation Therapy

Use of Rectal Spacers for Proton Beam Radiation Therapy for Localized Prostate Cancer: Prospective Clinical Study

The objective of this clinical study is to assess the utilization of perirectal spacers in localized prostate cancer patients undergoing proton beam therapy.

Principal Investigator: Edward Soffen, MD.

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PCORI: COMPPARE

A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer (COMPPARE)

The goal of this study is to determine if prostate cancer patients treated with proton therapy as compare to intensity-modulated radiation therapy (IMRT) experience improved Quality of Life (QOL), ( bowel urgency and /or bowel frequency, as measured by the validated EPIC instrument). The study will consists of 3000 total participants, 1500 proton and 1500 IMRT.

Principal Investigator: Brian Chon, MD

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MGH: PARTIQoL 11-497 

Prostate Advanced Radiation Technologies Investigating Quality of Life; A Phase III Randomized Clinical Trial of Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer

The goal of this study is to compare the side effects of two types of radiation therapy for the treatment of prostate cancer Stage 1 or 2: intensity-modulated radiation therapy (IMRT) or proton beam therapy (PBT).

Principal Investigator: Edward Soffen, MD

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MGH: PARTIQoL 13-217 Registry

Prostate Advanced Radiation Technologies Investigating Quality of Life Registry: A Companion to Phase III Randomized PARTIQoL Clinical Trial

This Registry will enroll men who are eligible for but decline enrollment and randomization in the PARTIQoL Trial: Phase III Randomized Clinical Trial of Proton Therapy vs IMRT for Low or Low-Intermediate Risk Prostate Cancer. The overall goal of the Registry is to assess the representativeness and generalizability of the randomized clinical trial findings to a broader spectrum of eligible patients.

Principal Investigator: Edward Soffen, MD

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Registry

PCG: REG001-09

Evaluation Tracking Project: A Prospective Chart Review of Patients Treated with Radiation Therapy

A registry trial to collect and analyze information from patients treated with proton therapy to improve patient care by an adequate understanding of the results and patient population at participating institutions.

Principal Investigator: Henry Tsai, MD

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