64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase III Study of Participants with Biochemical Recurrence of Prostate Cancer
Study Description
This is a multi-center, single arm, non-randomized, open-label study of 64Cu-SAR-bisPSMA administered to participants with a history of adenocarcinoma of the prostate and rising or detectable prostate specific antigen (PSA) after initial definitive treatment. Participants who provide informed consent will undertake a Screening visit(s) to determine their eligibility to participate in the study. The maximum Screening period for each participant is 60 days. All participants are required to have baseline conventional imaging, including both anatomical and molecular imaging. After the Screening period, eligible participants will enter the Imaging period and receive a single administration (200 MBq) of 64Cu-SAR-bisPSMA on Day 1, followed by a positron emission tomography/computed tomography (PET/CT) scan at 1 to 4 hours post-dose (“Day 1 scan”) and at 24 hours (±6hours) post-dose (“Day 2 scan”). The safety of 64Cu-SAR-bisPSMA will be assessed on Day 1 and Day 2 via vital signs and adverse events reporting. Participants will then continue into the Follow-up period to verify the 64Cu-SAR-bisPSMA PET/CT findings.
Eligibility
Study candidates must meet all the following criteria to be eligible for the study:
Inclusion
- At least 18 years of age.
- Signed informed consent.
- Life expectancy ≥ 12 months as determined by the Investigator.
- Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive treatment.
- Participant potentially eligible for salvage therapy with curative intent (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2).
- PSA level after definitive therapy:
a. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per
American Urological Association recommendation) or
b. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and OncologyPhoenix consensus definition).
- Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PETpositive lesion for histological confirmation of PC, where this is safe and feasible.
- An Eastern Cooperative Oncology Group performance status of 0-2.
- For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.
Study candidates who meet any of the following criteria are not to be enrolled in the study:
Exclusion
- Participants who received any investigational agent within 5 biological half-lives prior to Day 1.
- Participants administered any high energy (>300 KeV) gammaemitting radioisotope within 5 physical half-lives prior to Day 1.
- Participants with known predominant small cell or neuroendocrine PC.
- Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive treatment and/or salvage therapy with radiation).
- Ongoing treatment or treatment within 26 weeks prior to Day 1 with any systemic therapy (e.g., any investigational therapy, androgendeprivation therapy [ADT], Androgen Receptor Pathway Inhibitor [ARPI]) for PC.
- Participants for whom there is an intent to initiate a prohibited medication(s)/treatment(s) (refer to Section 7.3) during the course of the participant’s involvement in the study.
- Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
- Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study (including interfering with receiving the investigational product or not capable of having a PET scan).
