PET/CT Characterization of Treatment Resistance

About This Trial

This study is testing how specialized body scans can help doctors see why advanced prostate cancer stops responding to certain hormone therapies.
It is designed for adults with prostate cancer that has spread to other parts of the body who are either preparing to start or are currently taking specific hormone-blocking medications.
Before considering this study, you should know that participation lasts between nine months and two years and requires several imaging appointments.
To take part, you must be comfortable lying completely flat and still for at least 30 minutes at a time, be able to fast before scans, and not require strong prescription opioid medications to manage cancer pain.

This study will use different types of medical imaging to assess how lesions from advanced prostate cancer become resistant to second-generation AR-targeted therapy, and how the different types of imaging compare in that assessment.
Participants in this study have advanced prostate cancer and are either scheduled to start a second-generation androgen receptor (AR) targeted therapy (such as enzalutamide, abiraterone, or apalutamide) or are already being treated with one.
Participants can expect to be in the study for at least 9 months, and up to 2 years.

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is testing how specialized body scans can help doctors see why advanced prostate cancer stops responding to certain hormone therapies.

Full Eligibility Criteria

Inclusion Criteria

Histologically proven adenocarcinoma of the prostate.
At least 1 radiographic metastases as seen on conventional CT imaging or bone scan
Progressive prostate cancer as evident by at least two separate increase in PSA over nadir, and absolute PSA value at least 2 ng/ml (INTRINSIC RESISTANCE COHORT, ARSI patients ONLY)
Patients must be candidate for a second-generation androgen receptor (AR) inhibitor (e.g. enzalutamide, abiraterone, darolutamide, apalutamide), or Lu177-PSMA radioligand therapy (INTRINSIC RESISTANCE COHORT ONLY)
Men of age >18 years.
Patients must be able to comply with all study procedures, including having both the ability and willingness to lie flat for ≥ 30 minutes during imaging
Patients must be informed of the exploratory nature of the study and its potential risks, and must sign IRB-approved consent form indicating such understanding.
Life-expectancy at least 12 months
Patients currently receiving a second-generation androgen receptor (AR) inhibitor (e.g. enzalutamide, abiraterone, darolutamide, apalutamide) and must have had 1) PSA decline on treatment and 2) now have PSA increase over nadir while still on treatment (patients must be registered within 12 weeks of first documented PSA increase) (ACQUIRED RESISTANCE COHORT ONLY)

Exclusion Criteria

Must not have uncontrolled diabetes (fasting blood sugar > 200 mg/dL or inability to safely hold diabetes medication or fast 6 hours prior to FDG PET scan)
Prior treatment with second-generation AR inhibitor for prostate cancer in the metastatic disease setting (prior second-generation AR inhibitor in the neoadjuvant or adjuvant setting is permitted unless patient developed progression while on treatment) (INTRINSIC RESISTANCE COHORT, AR-INHIBITOR GROUP ONLY)
Pain or clinical symptoms from metastatic prostate cancer requiring opioid analgesics
Known neuro-endocrine prostate cancer
Prior radioisotope therapy for castration-resistant prostate cancer
To avoid the possibility of unintended coercion, vulnerable populations such as incarcerated subjects, subjects unable to provide their own informed consent and non-English speaking patients will not be considered

Diagnostic Test: F-fluorodeoxyglucose positron emission tomography (FDG PET)
Diagnostic Test: prostate-specific membrane antigen positron emission tomography (PSMA PET)