SMH Participates in Groundbreaking Prostate Cancer Study

October 23, 2024 | Sarasota

Prostate cancer is the most common non-skin cancer in men in the US, and the 4th most common tumor diagnosed worldwide. As part of its commitment to improving the diagnosis and staging of this disease, Sarasota Memorial Research Institute is proud to announce its participation in the Solar-Stage study sponsored by Curium. This clinical trial aims to evaluate a new investigational diagnostic product, Copper Cu 64 PSMA I&T Injection, for its ability to provide detailed images of prostate cancer tumors using positron emission tomography (PET) and computed tomography (CT) scans. The Copper Cu 64 PSMA I&T injection is under development as a radioactive PET imaging agent that specifically targets the prostate specific membrane antigens that are expressed on metastatic prostate cancer cells.

The study seeks to determine if Copper Cu 64 PSMA I&T Injection can safely and effectively be used to accurately stage prostate cancer by taking precise pictures of tumors in the body. Accurate staging is critical in guiding treatment decisions and improving patient outcomes. The safety and effectiveness of copper Cu 64 PSMA I&T have not been established by the United States Food and Drug Administration.

Participants in the study will undergo a series of evaluations. The process includes a screening visit to review medical history and obtain consent, followed by an imaging day where the injection will be administered, and PET/CT scans will be conducted to capture detailed images of the prostate cancer tumors. Participants will also receive follow-up care to monitor for any side effects and ensure their well-being. If surgery is part of their medical care, information from the procedure may be used in the research study.

“In terms of cancer specific survival, the higher the risk of prostate cancer at the time of diagnosis, the greater the benefit to have a robotic prostatectomy with an extended pelvic lymph node dissection as the first treatment for prostate cancer,” said Robert I. Carey, MD PhD FACS, Principal Investigator of this prostate cancer study and urologic surgeon with Sarasota Memorial’s First Physicians Group. “My hope is that the Curium 64 Solar Stage Research Study will help patients by clearly and accurately outlining the extent of their disease prior to surgery. It may allow for specific targeting and removal of lymph nodes distant to the prostate that might otherwise not be treated in other prostate cancer therapies. Patients could benefit from such treatments and may be spared future toxic therapies. We are very fortunate to have the study available in Sarasota for our patients.”

Inclusion Criteria:

• Male patients aged 18 or older, with histologically confirmed prostate adenocarcinoma.
• Scheduled for prostatectomy with pelvic lymph node dissection.
• Classified as having unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer according to the NCCN Guidelines Version 1.2023 or earlier.
• Able to understand and sign a written informed consent form.

Exclusion Criteria:

• Patients who have received androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy, local ablation, or any investigational treatment for prostate cancer before the prostatectomy.
• Participation in another interventional clinical trial within the last 30 days or receipt of an investigational product within five biological half-lives before study administration.
• Any medical condition or situation that, in the investigator’s opinion, could compromise study data or interfere with study requirements, including inability to undergo a PET scan.
• Planned administration of x-ray contrast within 24 hours, or another PET radiotracer within 10 half-lives, before the PET scan. If barium contrast is used, it must be cleared before the PET scan.
• Administration of high-energy (greater than 300 KeV) gamma-emitting radioisotopes within five half-lives before Copper Cu 64 PSMA I&T administration.
• Known hypersensitivity to the active substance or any excipient of the investigational product.
• Patients who have had a PSMA PET scan as part of standard care within 90 days before enrollment.