Trial of Copper Cu 64 PSMA I&T PET/CT imaging in prostate cancer meets primary end points

The phase 2 SOLAR trial (NCT05653856) exploring Copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer has met its primary end points, according to Curium, the developer of the diagnostic imaging agent.¹

All PET/CT images for the trial were interpreted by 3 independent readers who were blinded to all individual patient information.

Specifically, copper Cu 64 PSMA I&T injection achieved the co-primary efficacy end points of region-level correct localization rate and patient-level correct detection rate when used for PET/CT imaging to identify metastatic prostate cancer.

“The milestone announced today demonstrates Curium’s global commitment to driving innovations in prostate cancer diagnosis and treatment, and is extremely encouraging for prostate cancer patients,” Michael Patterson, chief executive officer of North America at Curium, stated in a press release.¹ “Our proven ability to reliably manufacture and distribute Cu-64 diagnostic agents throughout the United States means that we are well positioned for the upcoming phase 3 trials to ultimately improve the lives of patients.”

The prospective, open-label, phase 2 SOLAR study enrolled 26 patients with metastatic prostate cancer in the United States.

To enroll in the trial patients had to be at least 18 years old and have histologically proven prostate adenocarcinoma. Prior treatment with radical prostatectomy or radiation therapy with curative intent was required. Patients had to have disease recurrence following treatment, which the study protocol defined as having a PSA level >0.2 ng/mL in patients with prior radical prostatectomy and a 2 ng/mL rise in PSA level over post-treatment nadir in patients with prior radiation therapy. Additionally, patients had to have a minimum of 1 suspected extraprostatic site of disease as determined by prior imaging or diagnosed by biopsy.²

All PET/CT images for the trial were interpreted by 3 independent readers who were blinded to all individual patient information.

In addition to the 2 co-primary efficacy end points, the study had a primary safety end point of incidence of adverse events, as measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. There was also a secondary efficacy end point of image quality score.

“We are very pleased to report that our Copper Cu 64 PSMA I&T product for PET/CT imaging in the detection of recurrent prostate cancer has met the co-primary endpoints. Consistent with our mission to redefine the experience of cancer through our trusted legacy in nuclear medicine, we are encouraged by the readouts of the SOLAR phase 2 clinical trial,” Sakir Mutevelic, MD, MSc, chief medical officer at Curium, stated in a press release.¹ “Our goal is to accelerate the Copper Cu 64 PSMA I&T phase 3 clinical development and move forward with pivotal phase 3 clinical trials in biochemical recurrence and initial staging setting in metastatic prostate cancer in early 2024.”

References

1. Curium announces achievement of co-primary endpoints in phase 2 of its phase 1/2 SOLAR clinical trial imaging men with histologically-proven prostate cancer using copper Cu 64 PSMA I&T. Published online August 15, 2023. Accessed August 16, 2023. https://www.globenewswire.com/news-release/2023/08/15/2725665/0/en/Curium-Announces-Achievement-of-Co-Primary-Endpoints-in-Phase-2-of-Its-Phase-1-2-SOLAR-Clinical-Trial-Imaging-Men-With-Histologically-Proven-Prostate-Cancer-Using-Copper-Cu-64-PSMA.html

2. National Institutes of Health US National Library of Medicine ClinicalTrials.gov. Cu-64-PSMA-I&T positron emission tomography (PET) imaging of metastatic PSMA positive lesions in men with prostate cancer. Last updated March 22, 2023. Accessed August 16, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05653856