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AUA 2026

AUA 2026: AMPLIFY: A Phase 3 Study of 64Cu-SAR-bisPSMA Positron Emission Tomography in Participants with Biochemical Recurrence of Prostate Cancer

(UroToday.com) The 2026 American Urologic Association (AUA) Annual Meeting was host to a prostate cancer clinical trials-in-progress session. Dr. James Kearns presented AMPLIFY, an ongoing phase III trial of 64Cu-SAR-bisPSMA positron emission tomography (PET) in biochemically recurrent prostate cancer patients.

Prostate cancer is the second most prevalent cancer in men globally, and there is a need for improved prostate cancer imaging, reflected in a biochemical recurrence rate of 20 to 40% after initial definitive therapy.1,2 Despite advances in technology, many patients will fail to have their recurrence accurately localized by imaging, especially at low PSA levels. Imaging modalities that are widely available and can accurately detect, monitor, and restage residual/recurrent loco-regional and metastatic disease are therefore highly desirable.  PSMA is a type II transmembrane glycoprotein that is strongly overexpressed in prostate cancer, making it an ideal target for imaging and therapy. 64Cu-SAR-bisPSMA may offer several advantages over the currently approved PSMA PET agents for prostate cancer due to the bivalent structure of SAR-bisPSMA and the longer half-life of 64Cu (t1/2 = 12.7 hours), compared to the approved monovalent PSMA agents utilizing 18F and 68Ga (t1/2 < 2 hours):

  Prostate cancer is the second most prevalent cancer in men globally, and there is a need for improved prostate cancer imaging, reflected in a biochemical recurrence rate of 20 to 40% after initial definitive therapy.1,2 Despite advances in technology, many patients will fail to have their recurrence accurately localized by imaging, especially at low PSA levels. Imaging modalities that are widely available and can accurately detect, monitor, and restage residual / recurrent loco-regional and metastatic disease are therefore highly desirable.  PSMA is a type II transmembrane glycoprotein that is strongly overexpressed in prostate cancer, making it an ideal target for imaging and therapy. 64Cu-SAR-bisPSMA may offer several advantages over the currently approved PSMA PET agents for prostate cancer due to the bivalent structure of SAR-bisPSMA and longer half-life of 64Cu (t1/2 = 12.7 hours), compared to the approved monovalent PSMA agents utilizing 18F and 68Ga (t1/2 < 2 hours):

In the phase 2 COBRA trial of participants with biochemical recurrence and a negative or equivocal conventional imaging (including PSMA PET), next-day 64Cu-SAR-bisPSMA imaging detected more lesions than same-day imaging (129 versus 70 lesions; average across 3 readers) and identified a higher proportion of patients with a positive 64Cu-SAR-bisPSMA scan (71% versus 53%): 

  In the phase 2 COBRA trial of participants with biochemical recurrence and a negative or equivocal conventional imaging (including PSMA PET), next-day 64Cu-SAR-bisPSMA imaging detected more lesions than same-day imaging (129 versus 70 lesions; average across 3 readers) and identified a higher proportion of patients with a positive 64Cu-SAR-bisPSMA scan (71% versus 53%):

64Cu-SAR-bisPSMA PET/CT also detected more lesions up to 6 months earlier than standard of care PSMA PET in participants who received 18F-DCFPyL or 68Ga-PSMA-11 during COBRA follow-up:

  64Cu-SAR-bisPSMA PET/CT also detected more lesions up to 6 months earlier than standard of care PSMA PET in participants who received 18F-DCFPyL or 68Ga-PSMA-11 during COBRA follow-up:

AMPLIFY (NCT06970847) is a multi-center, single-arm, open-label phase 3 diagnostic performance study of 64CuSAR-bisPSMA PET/CT in participants with a history of prostate adenocarcinoma and rising or detectable PSA after initial definitive treatment. The primary objective is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer, with co-primary endpoints of participant-level correct detection rate and region-level positive predictive value assessed independently for Day 1 and Day 2. Key secondary objectives include assessment of safety, participant-level positive predictive value, and participant-level detection rate.

A total of 220 patients will be enrolled, and all participants are required to have baseline conventional imaging. Eligible patients will receive a single administration of 64Cu-SAR-bisPSMA (200 MBq) followed by a PET/CT scan on Day 1 (1-4 hours post-dose, same-day imaging) and on Day 2 (24 ± 6 hours post-dose, next-day imaging). Participants will then continue into the follow-up period to verify the 64Cu-SAR-bisPSMA PET/CT findings. The 64Cu-SAR-bisPSMA same and next-day scans will be interpreted individually by a qualified local reader and 3 independent, blinded, central readers for the presence of abnormal 64Cu-SAR-bisPSMA uptake. 64Cu-SAR-bisPSMA PET/CT results on same- and next-day imaging will then be assessed against a composite reference standard by a central expert panel:

  The 64Cu-SAR-bisPSMA same- and next-day scans will be interpreted individually by a qualified local reader and 3 independent, blinded, central readers for the presence of abnormal 64Cu-SAR-bisPSMA uptake. 64Cu-SAR-bisPSMA PET/CT results on same- and next-day imaging will then be assessed against a composite reference standard by a central expert panel

The study is currently open for recruitment in the United States and Australia:

  The study is currently open for recruitment in the United States and Australia:

Presented by: James Kearns, MD, Urologist, Endeavor Health, Evanston, IL

Written by: Rashid K. Sayyid, MD, MSc, Assistant Professor, Urologic Oncologist, Department of Urology at The University of Arizona and Banner University Medical Center, Tucson, AZ – @rksayyid on X during the American Urological Association (AUA) 2026 Annual Meeting, Washington, DC, Fri, May 15 – Mon, May 18, 2026. 

References:
  1. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2025;75(1):16–47.
  2. Van den Broeck T, van den Bergh RCN, Arfi N, et al. Prognostic value of biochemical recurrence following treatment with curative intent for prostate cancer: A systematic review. Eur Urol. 2019;75(6):967–987.
  3. Nordquist LT, McKay RR, Emmett L, et al. Assessment of safety and efficacy of ^64Cu-SAR-bisPSMA in participants with biochemical recurrence of prostate cancer and negative or equivocal standard-of-care imaging: Results from the phase I/II COBRA study. J Nucl Med. 2024;65(suppl 2):242291.
  4. Khan S, Papa N, Kneebone A, et al. Prospective comparison of ^64Cu-SAR-bisPSMA versus ^68Ga-PSMA-11 PET/CT for biochemical recurrence of prostate cancer following radical prostatectomy: Co-PSMA trial. Eur Urol. 2026. Published online March 27, 2026.