An Investigational Scan (PSMA PET/CT) for the Detection of Prostate-Specific Membrane Antigen Expression In Patients with Prostate Cancer Receiving Androgen Receptor Antagonist

Status: closed to accrual

This clinical trial studies whether giving a short course of a standard androgen receptor antagonist (blocker, e.g. apalutamide, darolutamide, or enzalutamide) causes a PSMA “flare,” and builds on previous reports of PSMA flare in patients treated with androgen deprivation therapy which may offer a new way to treat early recurrent prostate cancer. The amount of PSMA is detected by position emission tomography (PET)/computed tomography (CT) scans. PSMA is a chemical produced, or "expressed" in uniquely large amounts by prostate cancer cells, which can help identify and treat them. There is early evidence that certain drugs used in prostate cancer treatment -- such as standard androgen receptor (AR) antagonists (blockers) -- also cause cancer cells to temporarily increase PSMA expression. These "flares" of PSMA may offer opportunities for earlier identification and treatment. PET-CT scan is a procedure that combines the pictures from a positron emission tomography (PET) scan and a computed tomography (CT) scan. The PET and CT scans are done at the same time with the same machine. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. There is a new drug called 177lutetium-PSMA that is approved for advanced prostate cancer resistant to all therapies. This drug targets PSMA-producing cells with radiation. Before starting a clinical trial to see whether 177lutetium-PSMA could be effective earlier in prostate cancer therapy, investigators would like to learn whether they can increase the amount of PSMA marker on cancer cells so that this drug might be more effective. Additionally, investigators will test whether another standard form of hormonal therapy that does not lower testosterone—and therefore has fewer side effects—also increases PSMA, and thus whether a short course of this hormonal therapy should be used alongside 177lutetium-PSMA in early recurrent prostate cancer in the future. Diagnostic procedures, such as PSMA PET/CT scans, may help doctors detect PSMA levels in patients with prostate cancer.

Inclusion Criteria

COHORT I: Patients aged 40 or higher with prostate cancer that have been previously treated with primary definitive local therapies (prostatectomy with or without salvage radiation, or primary prostate radiation) and that are subsequently experiencing rising prostate-specific antigen (PSA) meeting criteria for biochemical failure (PSA > 0.2 ng/dL x 2 following prostatectomy, or PSA > 2 + nadir value following primary radiation)
COHORT I: PSMA PET/CT (Ga68, piflufolastat F-18, or other Food and Drug Administration [FDA]-approved tracer) during time of biochemical recurrence, and within 6 weeks of registration, showing at least one lesion suspicious for recurrent prostate cancer based on size and/or standardized uptake value (SUV)
COHORT I: Testosterone >100 ng/dL within 6 months prior to enrollment with no intervening hormonal therapies
COHORT I: Assigned by treating physician to receive standard-of-care androgen receptor (AR) antagonist monotherapy, using FDA-approved apalutamide, darolutamide, or enzalutamide
COHORT II: Patients with advanced metastatic castration resistant prostate cancer who are anticipated to begin standard-of-care 177Lu therapy
COHORT II: PSMA PET/CT (Ga68, piflufolastat F-18, or other FDA-approved tracer) within 6 weeks of registration
COHORT II: May have previously received apalutamide, darolutamide, or enzalutamide, but 3 months must have elapsed between last dose and study registration
COHORT II: May have previously received abiraterone at any point, including the time between baseline PSMA PET/CT and registration

Exclusion Criteria

COHORT I: High disease burden, significant symptoms of disease, or other clinical situation requiring medical/surgical castration and/or docetaxel during the time of the study
COHORT I: Not suitable for AR antagonist therapy (e.g. inability to swallow pills, poor adherence, advanced liver disease, prohibitive co-payment without available patient assistance funding, contraindicated drug-drug interaction)
COHORT I: AR antagonists other than apalutamide, darolutamide, or enzalutamide are not allowed on study
COHORT II: Prior receipt of 177Lu or other PSMA-directed therapies
COHORT II: Plan to start 177Lu therapy within the 4-week study period
COHORT II: Not suitable for AR antagonist therapy (e.g. inability to swallow pills, poor adherence, advanced liver disease, prohibitive co-payment without available patient assistance funding, contraindicated drug-drug interaction)
COHORT II: AR antagonists other than apalutamide, darolutamide, or enzalutamide are not allowed on study
COHORT II: Any second-generation AR antagonist within 3 months of study registration. Abiraterone during this period or prior is allowed

PRIMARY OBJECTIVE:

I. To assess the effects of short-term androgen receptor inhibition on prostate-specific membrane antigen (PSMA) expression in men with metastatic hormone-sensitive prostate cancer (mHSPC).

OUTLINE:

Patients receive standard of care AR antagonist consisting of apalutamide orally (PO), darolutamide PO, or enzalutamide PO and then undergo PSMA PET-CT scan one week after starting AR antagonist. Patients may undergo an additional PSMA PET-CT scan on study as well as blood sample collection throughout the study.

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An Investigational Scan (PSMA PET/CT) for the Detection of Prostate-Specific Membrane Antigen Expression In Patients with Prostate Cancer Receiving Androgen Receptor Antagonist

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