Studies launch of copper Cu 64 PSMA I&T PET/CT in prostate cancer

The first patients have been enrolled and scanned in the phase 3 SOLAR-STAGE and SOLAR-RECUR trials, evaluating the diagnostic performance of copper Cu 64 prostate-specific membrane-antigen (PSMA) I&T for PET/CT imaging in patients with prostate cancer, announced Curium, the developer of the agent, in a news release.¹

Both trials expect completion in 2025.

“The successful start of patient enrollment is a significant step forward for Curium’s Phase 3 SOLAR-STAGE and SOLAR-RECUR clinical trials. As we continue Curium’s journey to redefine the experience of cancer through our trusted legacy in nuclear medicine, we look forward to building on our well-established and successful 64-Cu diagnostic imaging platform,” said Sakir Mutevelic, MD, Curium’s Chief Medical Officer, in the news release.¹

The SOLAR-STAGE (NCT06235151) trial is assessing the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in the staging of men who have been newly diagnosed with unfavorable intermediate-, high-, or very high-risk prostate cancer and are planning to undergo radical prostatectomy with pelvic lymph node dissection (PLND).

The SOLAR-RECUR trial (NCT06235099) is evaluating the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in men with suspected biochemical recurrence of prostate cancer following radical prostatectomy or radiation therapy with curative intent.

Both trials are currently enrolling patients in the US, with additional sites expected to open in Europe later this year.

Amy Bartalotta, Vice President of Clinical Operations, added in the news release,¹ “To ensure that the SOLAR clinical trials recruit a diverse set of patients—including minority groups that are often more affected by and less likely to be screened for prostate cancer—we have 50 sites in the US and over 30 sites in Europe participating in these trials. We are pleased to announce the first patients enrolled and scanned were at XCancer under the direction of Dr. Luke Nordquist. We look forward to additional trial sites scanning patients across the US and Europe in the coming months.”

In total, the phase 3, prospective, open-label SOLAR-STAGE trial plans to enroll 323 adult patients who have received a new diagnosis of prostate cancer.² To be eligible for the trial, patients must have histologically proven adenocarcinoma, planned prostatectomy with PLND, and unfavorable intermediate- to very-high risk disease as per National Comprehensive Cancer Network Guidelines version 1.2023 and previous versions.

For the study, men will receive 8 mCi (± 10 percent) copper Cu 64 PSMA I&T via intravenous injection for staging of prostate cancer. The primary outcome measures are sensitivity and specificity at 4 hours post-injection. Secondary outcome measures are the inter- and intra-reader agreement of PET/CT interpretation and the incidence of adverse events (AEs). Other outcome measures include the detection rate, the sensitivity and specificity by risk group, and the impact of copper Cu 64 PSMA I&T PET/CT on the clinical management of patients.

The phase 3, prospective, open-label SOLAR-RECUR trial plans to enroll 200 adult patients with suspected biochemically recurrent prostate cancer.³

To be included in the study, patients must have histologically confirmed prostate adenocarcinoma, undergone radical prostatectomy over 6 weeks prior to screening or radiation over 1 year prior to screening with curative intent, and recurrent disease, as defined by a prostate-specific antigen (PSA) level greater than 0.2 ng/mL and a subsequent confirmatory PSA of greater than 0.2 ng/mL for those who underwent radical prostatectomy, or a PSA rise of 2 ng/mL over post-treatment nadir among those who underwent radiation therapy.

For the study, men will receive 8 mCi (± 10 percent) copper Cu 64 PSMA I&T via intravenous injection for the detection of PSMA expression. The primary outcome measures are the patient-level correct detection rate (CDR) and the region-level correct localization rate (CLR). The secondary outcome measures are the CDR and CLR by PSA level, the CDR and CLR by histopathology available vs unavailable, inter- and intra-reader agreement of PET/CT interpretation, and the incidence of AEs.

Both trials expect completion in 2025.

In August 2023, Curium also reported that their phase 2 SOLAR study (NCT05653856) of copper Cu 64 PSMA I&T PET/CT in patients with histologically confirmed metastatic prostate cancer met its co-primary end points of patient-level CDR and the region-level CLR.⁴ The study enrolled 26 patients within the US to evaluate the safety, biodistribution, and image quality of copper Cu 64 PSMA I&T PET/CT in detecting metastatic prostate cancer.

References

1. Curium enrolls first prostate cancer patients in its phase 3 SOLAR trials. News release. Curium. April 23, 2024. Accessed April 24, 2024. https://www.curiumpharma.com/2024/04/23/patients-phase-3-solar/

2. Copper Cu 64 PSMA I&T PET imaging in men with newly diagnosed prostate cancer (Solar-Stage). ClinicalTrials.gov. Last updated January 31, 2024. Accessed April 24, 2024. https://clinicaltrials.gov/study/NCT06235151

3. Copper Cu 64 PSMA I&T PET imaging in men with suspected recurrence of prostate cancer (Solar-Recur). ClinicalTrials.gov. Last updated January 31, 2024. Accessed April 24, 2024. https://clinicaltrials.gov/study/NCT06235099

4. 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. News release. Curium. August 15, 2023. Accessed April 24, 2024. https://www.curiumpharma.com/2023/08/15/phase-2-solar-study-of-copper-cu-64-psma-it/