PET/CT Characterization of Treatment Resistance in Patients with Metastatic Prostate Cancer

Status: active

This clinical trial examines medical imaging of lesions (sites of disease) caused by the spread of prostate cancer. Medical scans help in learning how well cancer treatments works to kill prostate cancer cells and allow doctors to plan better treatment. Positron emission tomography (PET) is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, that some cancers take up and can be seen with PET. CT utilizes x-rays that traverse body from the outside. Computed tomography (CT) images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient’s body. Using different types of medical imaging may help researchers assess how lesions from prostate cancer become resistant to second-generation androgen resistant-targeted therapy, and how the different types of imaging compare in that assessment.

Inclusion Criteria

Histologically proven adenocarcinoma of the prostate.
At least 1 radiographic metastases as seen on conventional CT imaging or bone scan.
COHORT A: Progressive prostate cancer as evident by at least two separate increase in PSA over nadir, and absolute PSA value at least 2 ng/ml.
Patients must be candidate for a second-generation androgen receptor (AR) inhibitor (e.g. enzalutamide, abiraterone, apalutamide).
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 Institutional Review Board (IRB)-approved consent form indicating such understanding.
Life-expectancy at least 12 months.
COHORT B: Patients currently receiving a second-generation androgen receptor (AR) inhibitor (e.g. enzalutamide, abiraterone, 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).
Men of all races and ethnic groups are eligible for this trial.

Exclusion Criteria

Visceral metastases (e.g. liver, lung or brain).
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).
COHORT A: 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).
Pain or clinical symptoms from metastatic prostate cancer requiring opioid analgesics.
Known neuro-endocrine prostate cancer.
Prior cytotoxic chemotherapy or 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.
Women are excluded given that prostate cancer is a male disease.

Additional locations may be listed on ClinicalTrials.gov for NCT05647564.

United States

Wisconsin

Madison

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Status: Active

Contact: Christos Kyriakopoulos

Email: ckyriako@medicine.wisc.edu

University of Wisconsin Carbone Cancer Center - University Hospital

Status: Active

Contact: Christos Kyriakopoulos

Phone: 608-263-0786

Email: ckyriakopoul@wisc.edu

PRIMARY OBJECTIVES:

I. To characterize intrinsic resistance based on FDG PET/CT. ( Intrinsic Resistance Cohort)

II. To characterize intrinsic resistance based on PSMA PET/CT. (Intrinsic Resistance Cohort)

III. To characterize acquired resistance based on FDG PET/CT. (Acquired Resistance Cohort)

IV. To characterize acquired resistance based on PSMA PET/CT. (Acquired Resistance Cohort)

SECONDARY OBJECTIVES:

I. To correlate amount of resistance on FDG and PSMA PET/CT to time to PSA progression (PCWG1). (Intrinsic Resistance Cohort)

II. To correlate amount of resistance on FDG and PSMA PET/CT to time to radiographic progression (PCWG2). (Intrinsic Resistance Cohort)

III. To correlate amount of resistance on FDG and PSMA PET/CT to time to No Longer Clinical Benefit (PCWG3). (Intrinsic Resistance Cohort)

IV. To correlate amount of resistance on FDG and PSMA PET/CT to time to radiographic progression (PCWG2). (Acquired Resistance Cohort)

V. To correlate amount of resistance on FDG and PSMA PET/CT to duration on treatment (PCWG3). (Acquired Resistance Cohort)

EXPLORATORY OBJECTIVES:

I. To evaluate change in FDG to PSMA expression and how it may correlate to PSA progression (PCWG1), time to radiographic progression (PCWG2), and time to No Longer Clinical Benefit (PCWG3). (Intrinsic Resistance Cohort)

II. To evaluate change in FDG to PSMA expression and how it may correlate to time to radiographic progression (PCWG2), and time to No Longer Clinical Benefit (PCWG3). (Acquired Resistance Cohort)

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT A: Patients scheduled to start second-generation androgen receptor (AR)-directed therapies receive FDG via injection and undergo PET/CT on study. Patients then receive PSMA and undergo PET/CT on study. Patients also undergo collection of blood samples throughout the trial.

COHORT B: Patients being treated with second-generation AR-directed therapies and have shown an increase in their PSA levels receive FDG via injection and undergo PET/CT on study. Patients then receive PSMA and undergo PET/CT on study. Patients also undergo collection of blood samples throughout the trial.

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PET/CT Characterization of Treatment Resistance in Patients with Metastatic Prostate Cancer

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