Prostate Cancer Clinical Trial

The AMPLIFY trial is evaluating the effectiveness of a new PSMA PET tracer, 64Cu-SAR-bisPSMA, in detecting prostate cancer recurrence in patients who have rising PSA levels after their initial cancer treatment, such as surgery, radiation, or other therapies.

This trial aims to improve the ability of doctors to locate areas where prostate cancer may have returned, leading to more accurate treatment plans and potentially better outcomes for patients with recurrent prostate cancer.

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Patients are eligible if they are/have:

1. At least 18 years of age.
2. Signed informed consent.
3. Life expectancy ≥ 6 months as determined by the Investigator.
4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
5. Participant potentially eligible for salvage therapy with curative intent.
6. PSA level after definitive therapy:
   1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per AUA recommendation) or
   2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per ASTRO-Phoenix consensus definition).
7. Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible.
8. An Eastern Cooperative Oncology performance status of 0-2.

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