First Patient Imaged in Phase 3 AMPLIFY Trial for BCR of Prostate Cancer
The pivotal AMPLIFY trial aims to support FDA approval of ⁶⁴Cu-SAR-bisPSMA as a best-in-class imaging tool in prostate cancer.
Conceptual image for viral etiology of prostate cancer: © Dr_Microbe - stock.adobe.com
The first patient has been imaged in the registrational phase 3 AMPLIFY (NCT06970847) trial of 64Cu-SAR-bisPSMA in patients with biochemical recurrence (BCR) of prostate cancer.1
64Cu-SAR-bisPSMA is a novel diagnostic that has demonstrated superiority compared with current-generation radiopharmaceuticals. In preclinical data, the agent has shown to have superior tumor uptake vs PSMA-617. This suggests its potential to become a best-in-class theranostic agent for patients with prostate cancer.2
This patient is being treated at XCancer in Omaha, Nebraska.1
"We are thrilled to recruit the first participant in the AMPLIFY trial and to image them just over a week after study initiation. 64Cu-SAR-bisPSMA could become a best-in-class diagnostic prostate-specific membrane antigen (PSMA) agent, and we are [honored] to be part of this registrational trial that intends to gather sufficient data for a new drug application and a potential subsequent [commercialization] of this next-generation product,” Luke Nordquist, MD, FACP, urologic medical oncologist, chief executive officer of XCancer, said in a press release.
Initiation of the phase 3 AMPLIFY trial follows a successful end-of-phase meeting with the FDA.3 AMPLIFY is now evaluating the novel diagnostic agent 64Cu-SAR-bisPSMA in patients with BCR of prostate cancer.
"We have already observed the potential benefits of 64Cu-SAR-bisPSMA based on data from earlier phase trials such as Clarity's PROPELLER [NCT03732820] and COBRA [NCT05249127] studies and look forward to participating in the AMPLIFY trial, providing this [optimized] product to our patients in need of novel diagnostic solutions. The COBRA trial that laid foundation for AMPLIFY in patients with BCR of prostate cancer showed that more lesions and more patients with a positive scan were identified on 64Cu-SAR-bisPSMA positron emission tomography compared to conventional scans and on next-day vs same-day imaging,” explained Nordquist.
"“64Cu-SAR-bisPSMA also allowed for the identification of lesions in the 2-mm range and was able to detect lesions at least 6 months earlier than the current standard-of-care PSMA PET agents. The team at XCancer looks forward to further building on this evidence in the AMPLIFY trial as we progress towards our mutual goal of improving treatment outcomes for patients with cancer,” he continued.
Background of the AMPLIFY Trial
AMPLIFY is a nonrandomized, single-arm, open-label, multicenter trial that plans to enroll approximately 220 patients with prostate cancer who exhibit rising or detectable prostate-specific antigen (PSA) levels after undergoing initial definitive treatment. Investigators plan to evaluate the diagnostic performance of 64Cu-SAR-bisPSMA in detecting prostate cancer recurrence via PET/CT imaging.
The study aims to examine the ability of both 64Cu-SAR-bisPSMA PET and CT to detect recurrence of prostate cancer.4 This will be evaluated across 2 imaging timepoints: day 1, which is the day of administration and same-day imaging, and day 2, which will be approximately 24 hours post administration and next-day imaging.
Patients will be enrolled at multiple clinical sites across the US and Australia. Enrollment is open to patients aged 18 years and older with a life expectancy of at least 6 months (as determined by the investigator), histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy, and an ECOG performance status of 0 to 2. Patients must also be willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of prostate cancer.
As a pivotal trial, AMPLIFY is expected to deliver final results that will support a submission to the FDA for the approval of ⁶⁴Cu-SAR-bisPSMA as a novel diagnostic imaging agent for BCR in prostate cancer.1
"We are excited to have imaged the first patient in the AMPLIFY trial and look forward to further progressing recruitment and opening clinical sites across the US and Australia, providing access to 64Cu-SAR-bisPSMA in both countries as part of this trial,” said Alan Taylor, PhD, executive chairperson of Clarity Pharmaceuticals, in the press release. “We have built a robust supply of copper-64 with a wide network of product manufacturers in preparation for our 2 phase 3 trials, AMPLIFY in BCR and CLARIFY [NCT06056830] in preprostatectomy, and potential [commercialization].”
"With prostate cancer prevalence increasing year after year, we look forward to overcoming limitations of the current-generation PSMA PET diagnostics, such as sensitivity and accessibility, making earlier and more accurate detection of recurrent disease a potential reality and bringing our optimised diagnostic to more men with this insidious disease around the world," Taylor added.
REFERENCES:
First patient imaged in phase III AMPLIFY trial with 64Cu-SAR-bisPSMA PET/CT. News release. Clarity Pharmaceuticals. May 29, 2025. Accessed May 29, 2025. https://tinyurl.com/mpe836mx
Pipeline. Clarity Pharmaceuticals. Accessed May 29, 2025. https://www.claritypharmaceuticals.com/pipeline/sar-bispsma/
Positive guidance from the U.S. FDA on 64Cu-SAR-bisPSMA phase III trial in patients with recurrence of prostate cancer. News release. Clarity Pharmaceuticals. October 14, 2024. Accessed May 29, 2025. https://tinyurl.com/45z2b4um
64Cu-SAR-bisPSMA positron emission tomography: A phase 3 study of participants with biochemical recurrence of prostate cancer (AMPLIFY). ClinicalTrials.gov. Updated May 25, 2025. Accessed May 29, 2025. https://clinicaltrials.gov/study/NCT06970847?term=NCT06970847
