PET/CT Characterization of Treatment Resistance

Launched by UNIVERSITY OF WISCONSIN, MADISON · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how advanced prostate cancer can resist certain treatments known as second-generation androgen receptor (AR) inhibitors, which include medications like enzalutamide and abiraterone. Researchers will use different medical imaging techniques to better understand how these resistant cancer lesions behave. The trial is open to men aged 18 and older who have been diagnosed with prostate cancer that has spread and are either about to start or are already on one of these treatments.

Participants can expect to be involved in the study for a minimum of 9 months, with the possibility of staying for up to 2 years. To qualify, they need to have specific criteria, such as having evidence of cancer spread shown in imaging tests and a certain level of prostate-specific antigen (PSA) in their blood, which helps to track the cancer's progress. It's important to note that participants will need to be able to lie flat for imaging sessions and must be informed about the study's exploratory nature and any associated risks. Overall, this study aims to improve understanding of treatment resistance in prostate cancer, which could lead to better management strategies in the future.

Gender

MALE

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 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