Treatment with 177Lu-PSMA-I&T in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (CRPC) demonstrated meaningful benefits in radiographic progression-free survival (PFS).
177Lu-PSMA-I&T is a type of radioligand therapy that targets PSMA, according to the National Cancer Institute. This helps destroy the prostate cancer cells.
The phase 3 ECLIPSE trial, which included approximately 439 patients, met its primary end point, which was radiographic PFS, according to a news release from Curium, the manufacturer of 177Lu-PSMA-I&T.
The pivotal trial is comparing the safety and efficacy of 177Lu-PSMA-I&T with hormone therapy in patients with mCRPC, the release stated.
Glossary
Hormone therapy: a treatment that involves adding, blocking, or removing hormones.
Prostate-specific membrane antigen (PSMA): a protein that is found on the surface of prostate cells.
Primary end point: the main outcome measured in a clinical trial to determine if treatment was effective.
Radiographic progression-free survival (PFS): progression-free survival is the time patients live without their cancer worsening or spreading. Radiographic PFS refers to how well patients respond to radiation therapy without experiencing disease worsening.
Millicurie: measurement of radiation.
SPECT imaging: a nuclear imaging technique that uses a radioactive tracer and a special camera to create 3D images of how well organs and tissues in the body are working.
Dosimetry analysis: tools to help estimate the amount of radiation absorbed in the body.
“ECLIPSE is the first Phase 3 trial investigating a 200 mCi [7.4 GBq] dose of 177Lu-PSMA-I&T administered every six weeks for up to six doses, demonstrating clinical benefit, in mCRPC patients before receiving taxane-based chemotherapy.” Dr. Sakir Mutevelic, chief medical officer of Curium, said in the news release. “Curium will continue to work with the FDA as the clinical trial data matures, on a regulatory submission plan for this potentially important product for patients, their caregivers and the health care providers treating prostate cancer.”
READ MORE: PSMA-Targeted Therapy May Decrease PSA Levels in Metastatic Prostate Cancer Subset
Previously, Curium announced ECLIPSE had enrolled more than 400 patients, ahead of schedule, across 51 trial sites in the United States and Europe.
Patients will be randomly assigned to treatment with the investigated agent and will receive up to six treatments every six weeks at a dose of 200 millicurie (mCi), and all enrolled patients will be evaluated for side effects and safety labs throughout the study. Additionally, the progression of disease will be assessed radiographically and through conventional imaging in addition to prostate-specific antigen levels and symptom recording throughout the course of treatment.
Furthermore, at selected participating clinical sites, 30 patients will participate in a pharmacokinetic and radiation dosimetry sub-study. These patients will receive SPECT imaging following each treatment cycle for dosimetry analysis and patients will not be randomly assigned.
“The ECLIPSE achievement of its primary end point represents an important clinical milestone in the development of our prostate theranostic program,” Michael Patterson, chief medical officer of Curium North America, added in the release. “This underscores Curium’s continued commitment and focus on nuclear medicine diagnostics and therapeutics. Curium will continue to work to fulfill its mission of redefining the experience of cancer through our trusted legacy in nuclear medicine by ensuring unrestricted access to this important product, if approved.”
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