PET/CT Characterization of Treatment Resistance
PET/CT Characterization of Treatment Resistance of AR-targeted Therapies in mCRPC
Sponsor: University of Wisconsin, Madison
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Characterize intrinsic resistance based on FDG and PSMA PET through change in individual lesion update levels.
Time frame: Baseline to 12 weeks
Characterize change in intrinsic resistance based on FDG and PSMA PET.
Time frame: Baseline to 12 weeks
Characterize change in intrinsic resistance based on FDG and PSMA PET.
Time frame: 12 weeks to 36 weeks
Characterize change in intrinsic resistance based on FDG and PSMA PET.
Time frame: Baseline to 36 weeks
Secondary Endpoints
Correlate amount of intrinsic resistance on FDG and PSMA PET to predict time to PSA progression
Correlate amount of intrinsic resistance on FDG and PSMA PET to predict time to radiographic progression
Correlate amount of intrinsic resistance on FDG and PSMA PET to predict time duration on treatment
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 androge…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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