Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-03-06
2026-03-01
Brief Summary
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Detailed Description
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There are two medical imaging scans that will be done for research purposes in this study. One is called 18F-fluorodeoxyglucose positron emission tomography (FDG PET) and the other is prostate-specific membrane antigen positron emission tomography (PSMA PET). These scans are done simultaneously with computed tomography (CT) scanning. Participants will be scheduled to have 6 scans, 3 FDG PET/CT scans and 3 PSMA PET/CT scans.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Intrinsic Resistance Cohort (Cohort A)
Participants assigned to Cohort A have advanced prostate cancer and are scheduled to start a second-generation AR-targeted (such as enzalutamide, abiraterone, darolutamide, or apalutamide) or PSMA directed (e.g. Lu177-PSMA) therapies .
F-fluorodeoxyglucose positron emission tomography (FDG PET)
Imaging scan
prostate-specific membrane antigen positron emission tomography (PSMA PET)
Imaging scan
Acquired Resistance Cohort (Cohort B)
Participants are assigned to Cohort B if they have advanced prostate cancer, are already on a second-generation AR-targeted therapy, and have shown an increase in their PSA (prostate-specific antigen) levels.
F-fluorodeoxyglucose positron emission tomography (FDG PET)
Imaging scan
prostate-specific membrane antigen positron emission tomography (PSMA PET)
Imaging scan
Interventions
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F-fluorodeoxyglucose positron emission tomography (FDG PET)
Imaging scan
prostate-specific membrane antigen positron emission tomography (PSMA PET)
Imaging scan
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Glenn Liu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Robert Jeraj, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-0910
Identifier Type: OTHER
Identifier Source: secondary_id
A534260
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/MEDICINE/HEM-ONC
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2022-09580
Identifier Type: REGISTRY
Identifier Source: secondary_id
Protocol Version 3/22/2024
Identifier Type: OTHER
Identifier Source: secondary_id
2022-0910
Identifier Type: -
Identifier Source: org_study_id
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