Imaging to Understand Prostate Cancer Treatment Resistance

This study is looking at how advanced prostate cancer becomes resistant to certain treatments like enzalutamide, abiraterone, or apalutamide. It uses special imaging scans called F-fluorodeoxyglucose positron emission tomography (FDG PET) and prostate-specific membrane antigen positron emission tomography (PSMA PET) to understand these changes. You might be able to join if you are a man aged 18 or older with advanced prostate cancer that has spread, and you are either starting one of these treatments or are already on one and your prostate-specific antigen (PSA) levels are rising. The study aims to see how these imaging scans can help characterize treatment resistance. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 25 men. It has two groups based on whether you are starting or already on a specific prostate cancer treatment.
What's involved
You will have 6 imaging scans (3 FDG PET/CT scans and 3 PSMA PET/CT scans) over a period of at least 9 months, and up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
The study will track changes in resistance based on imaging from baseline up to 36 weeks.

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NCT05647564

PET/CT Characterization of Treatment Resistance

Recruiting
NAAges 18+InterventionalDiagnostic
University of Wisconsin, Madison
~25 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:F-fluorodeoxyglucose positron emission tomography (FDG PET)prostate-specific membrane antigen positron emission tomography (PSMA PET)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Characterize intrinsic resistance based on FDG and PSMA PET through change in individual lesion update levels.
Measured over Baseline to 12 weeks
+4 more outcomes measured
Prostate Cancer
1 sites across 1 states
Wisconsin1
  • Glenn Liu, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
  • Robert Jeraj, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

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Eligibility criteria

Inclusion

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

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
  • Characterize intrinsic resistance based on FDG and PSMA PET through change in individual lesion update levels.Baseline to 12 weeks

    Changes in individual lesion update levels (ΔiSUVtotal) will be calculated. SUVtotal is a metric of activity, for which less activity is better.

  • Characterize change in intrinsic resistance based on FDG and PSMA PET.Baseline to 12 weeks

    Changes in individual lesion update levels (ΔiSUVtotal) will be calculated. SUVtotal is a metric of activity, for which a decrease in activity is better.

  • Characterize change in intrinsic resistance based on FDG and PSMA PET.12 weeks to 36 weeks

    Changes in individual lesion update levels (ΔiSUVtotal) will be calculated. SUVtotal is a metric of activity, for which a decrease in activity is better.

  • Characterize change in intrinsic resistance based on FDG and PSMA PET.Baseline to 36 weeks

    Changes in individual lesion update levels (ΔiSUVtotal) will be calculated. SUVtotal is a metric of activity, for which a decrease in activity is better.

  • Characterize acquired resistance at the time of progressionBaseline to 36 weeks

    Percentage and absolute changes in individual lesion update levels (ΔiSUVtotal) will be calculated.