Enrollment goal met in phase 3 SOLAR-RECUR trial

The target enrollment has been met ahead of schedule in the phase 3 SOLAR-RECUR trial (NCT06235099), evaluating the diagnostic performance ofcopper Cu 64 prostate-specific membrane antigen (PSMA) I&T PET/CT in men with suspected biochemical recurrence of prostate cancer after radical prostatectomy or radiation therapy with curative intent, Curium announced in a news release.¹

An additional phase 3 trial of copper Cu 64 PSMA I&T PET/CT, SOLAR-STAGE, is continuing to enroll patients.

“The completion of enrollment of the SOLAR-RECUR trial is yet another significant milestone for Curium,” said Sakir Mutevelic, MD, Curium’s Chief Medical Officer, in the news release.¹ “Cu 64 PSMA I&T represents an important pillar in the development of our theranostic program for prostate cancer patients and the health care professionals treating them. Curium is very thankful to the hundreds of health care professionals from over 30 sites across the U.S. who have enrolled their patients in this pivotal trial.”

The phase 3, prospective, open-label SOLAR-RECUR trial enrolled 235 adult patients with suspected biochemically recurrent prostate cancer.²

To be included in the study, patients needed to have histologically confirmed prostate adenocarcinoma and had undergone radical prostatectomy over 6 weeks prior to screening or radiation over 1 year prior to screening with curative intent. Participants also needed to have 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%) 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 status, inter- and intra-reader agreement of PET/CT interpretation, and the incidence of adverse events (AEs).

An additional phase 3 trial of copper Cu 64 PSMA I&T PET/CT, SOLAR-STAGE, is continuing to enroll patients across clinical trial sites in the US, with locations soon to open in Europe. The SOLAR-STAGE trial is evaluating the performance of copper Cu 64 PSMA I&T PET/CT in the staging of men with newly diagnosed unfavorable intermediate-risk, high-risk, or very-high-risk prostate cancer electing to undergo radical prostatectomy with pelvic lymph node dissection (PLND).

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.³ 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%) 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.

Final completion of both the SOLAR-RECUR and the SOLAR-STAGE trials is anticipated for July 2025.

References

1. Curium completes enrollment early of phase 3 SOLAR-RECUR prostate cancer trial. News release. Curium. November 19, 2024. Accessed November 21, 2024. https://www.biospace.com/press-releases/curium-completes-enrollment-early-of-phase-3-solar-recur-prostate-cancer-trial

2. Copper Cu 64 PSMA I&T PET imaging in men with suspected recurrence of prostate cancer (Solar-Recur). ClinicalTrials.gov. Last updated November 18, 2024. Accessed November 21, 2024. https://clinicaltrials.gov/study/NCT06235099

3. Copper Cu 64 PSMA I&T PET imaging in men with newly diagnosed prostate cancer (Solar-Stage). ClinicalTrials.gov. Last updated November 4, 2024. Accessed November 21, 2024. https://clinicaltrials.gov/study/NCT06235151