Enrollment goal met in pivotal trial of 64Cu-SAR-bisPSMA for BCR of prostate cancer

The pivotal phase 3 AMPLIFY trial (NCT06970847), assessing the diagnostic ability of ⁶⁴Cu-SAR-bisPSMA PET/CT for biochemical recurrence (BCR) of prostate cancer, has met its enrollment goal, Clarity Pharmaceuticals announced.¹

The company reported that the trial exceeded the planned number of participants across US and Australian trial sites. Consent for new patients has stopped at all sites and will remain completed pending confirmation of screening assessments for the remaining participants.

“Our team is excited to have reached this initial recruitment milestone in the AMPLIFY trial in just 9 months since we imaged our first participant in the study. This is no small feat, given we achieved this phenomenal pace of recruitment despite 3 SOC [standard-of-care] products already in the market, commercialized by 4 different companies,” said Alan Taylor, PhD, executive chairperson of Clarity Pharmaceuticals, in the news release.¹ “Despite the variations in the sites’ activation times, the speed of enrollment in this trial not only highlights the unmet need in the BCR space but also indicates the strong demand for ⁶⁴Cu-SAR-bisPSMA from clinicians and patients seeking more effective and accurate prostate cancer detection diagnostics.”

The AMPLIFY trial is evaluating the diagnostic ability of ⁶⁴Cu-SAR-bisPSMA to detect the recurrence of prostate cancer in men with a prostate-specific antigen (PSA) level above 0.2 ng/mL. The trial planned to enroll approximately 220 participants, with the first patient imaged in May 2025.

To be eligible for enrollment, patients had to have a rising or detectable PSA level following initial definitive therapy, a life expectancy of at least 6 months, and an ECOG performance status of 0 to 2. Those enrolled in the study will receive a single dose of ⁶⁴Cu-SAR-bisPSMA at the dose level of 200 MBq.²

The primary end point is the patient-level correct detection rate and the region-level positive predictive value. Efficacy will be assessed on same-day imaging (day 1, day of administration) and next-day imaging (day 2, approximately 24 hours post administration). Secondary end points include safety and tolerability, inter- and intra-reader variability, and detection rates in patients with negative or equivocal conventional imaging at baseline. All end points will be assessed for up to 52 weeks.²

Trial platform for ⁶⁴Cu-SAR-bisPSMA

The FDA granted ⁶⁴Cu-SAR-bisPSMA a fast track designation in January 2025 for PET imaging of prostate-specific membrane antigen (PSMA)-positive lesions in patients with BCR of prostate cancer following initial definitive therapy.

The agent also has a fast track designation for patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy. The pivotal phase 3 CLARIFY trial (NCT06056830) is assessing the agent in this indication. According to Clarity Pharmaceuticals, recruitment in CLARIFY is expected to close by the end of 2026.

Results from AMPLIFY and CLARIFY are intended to support applications to the FDA seeking approval of ⁶⁴Cu-SAR-bisPSMA as a diagnostic imaging agent in BCR of prostate cancer and for ⁶⁴Cu-SAR-bisPSMA in patients with prostate cancer who are candidates for definitive therapy, respectively.

Clarity’s theranostic agent, ⁶⁷Cu-SAR-bisPSMA, also received a fast track designation and is being assessed in the phase 1/2a SECuRE trial (NCT04868604). Results from the dose-expansion cohorts of this study are intended to support progression to a phase 3 registrational trial of ⁶⁷Cu-SAR-bisPSMA in metastatic castration-resistant prostate cancer.

“We also look forward to closing recruitment in the CLARIFY trial this year and progressing our theranostic phase 1/2a SECuRE trial toward completion,” Taylor concluded in the news release.¹ “Together with 3 fast track designations we have for SAR-bisPSMA and positive interactions with the US FDA to date, these milestones place us closer than ever to commercialization of this exciting agent through the entirety of the prostate cancer journey, from first detection to late-stage metastatic disease.”

REFERENCES

1. Registrational phase III AMPLIFY trial: target number of participants achieved. News release. Clarity Pharmaceuticals. March 10, 2026. Accessed March 10, 2026. https://www.claritypharmaceuticals.com/news/amplify_target_achieved/

2. 64Cu-SAR-bisPSMA positron emission tomography: a phase 3 study of participants with biochemical recurrence of prostate cancer (AMPLIFY). ClinicalTrials.gov. Updated March 18, Accessed March 27, 2026. https://clinicaltrials.gov/study/NCT06970847