Prostate CancerNCT05647564
PET/CT Characterization of Treatment Resistance
A study testing F-fluorodeoxyglucose positron emission tomography (FDG PET) and prostate-specific membrane antigen positron emission tomography (PSMA PET) in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will use different types of medical imaging to assess how lesions from advanced prostate cancer become resistant to second-generation AR-targeted therapy, and how the different types of imaging compare in that assessment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- F-fluorodeoxyglucose positron emission tomography (FDG PET) and prostate-specific membrane antigen positron emission tomography (PSMA PET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
Cancer Connect, 800-622-8922, clinicaltrials@cancer.wisc.edu
John Floberg, MD, PhD
About this study
Official title: PET/CT Characterization of Treatment Resistance of AR-targeted Therapies in mCRPC
This study will use different types of medical imaging to assess how lesions from advanced prostate cancer become resistant to second-generation AR-targeted therapy, and how the different types of imaging compare in that assessment. Participants in this study have advanced prostate cancer and are either scheduled to start a second-generation androgen receptor (AR) targeted therapy (such as enzalutamide, abiraterone, or apalutamide) or are already being treated with one. Participants can expect to be in the study for at least 9 months, and up to 2 years.
Read the detailed description
There are two groups, or cohorts, in this study. Participants are assigned to Cohort A if they have advanced prostate cancer and are scheduled to start a second-generation AR-targeted therapy (such as enzalutamide, abiraterone, darolutamide, or apalutamide) or PSMA directed radiotherapy (e.g. Lu177-PSMA radio-ligand therapy. 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.
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
- Prostate Cancer
- Being tested
- F-fluorodeoxyglucose positron emission tomography (FDG PET), prostate-specific membrane antigen positron emission tomography (PSMA PET)
- Keywords
- androgen receptor targeted therapy, imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-fluorodeoxyglucose positron emission tomography (FDG PET)Diagnostic test
Imaging scan
prostate-specific membrane antigen positron emission tomography (PSMA PET)Diagnostic test
Imaging scan
| Study group | Role | What they receive |
|---|---|---|
| Intrinsic Resistance Cohort (Cohort A) | Other | 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 . Receives: Diagnostic Test: F-fluorodeoxyglucose positron emission tomography (FDG PET); Diagnostic Test: prostate-specific membrane antigen positron emission tomography (PSMA PET) |
| Acquired Resistance Cohort (Cohort B) | Other | 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. Receives: Diagnostic Test: F-fluorodeoxyglucose positron emission tomography (FDG PET); Diagnostic Test: prostate-specific membrane antigen positron emission tomography (PSMA PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize intrinsic resistance based on FDG and PSMA PET through change in individual lesion update levels.
Changes in individual lesion update levels (ΔiSUVtotal) will be calculated. SUVtotal is a metric of activity, for which less activity is better.
Measured: Baseline to 12 weeks
Characterize change in intrinsic resistance based on FDG and PSMA PET.
Changes in individual lesion update levels (ΔiSUVtotal) will be calculated. SUVtotal is a metric of activity, for which a decrease in activity is better.
Measured: Baseline to 12 weeks
Characterize change in intrinsic resistance based on FDG and PSMA PET.
Changes in individual lesion update levels (ΔiSUVtotal) will be calculated. SUVtotal is a metric of activity, for which a decrease in activity is better.
Measured: 12 weeks to 36 weeks
Characterize change in intrinsic resistance based on FDG and PSMA PET.
Changes in individual lesion update levels (ΔiSUVtotal) will be calculated. SUVtotal is a metric of activity, for which a decrease in activity is better.
Measured: Baseline to 36 weeks
Characterize acquired resistance at the time of progression
Percentage and absolute changes in individual lesion update levels (ΔiSUVtotal) will be calculated.
Measured: Baseline to 36 weeks
Secondary outcomes (3)
Correlate amount of intrinsic resistance on FDG and PSMA PET to predict time to PSA progression
Analysis will be conducted to evaluate whether changes in lesion uptake values predict time to PSA progression. PSA progression will be 25% increase and >2 ng/mL above PSA nadir
Measured: Baseline to 36 weeks
Correlate amount of intrinsic resistance on FDG and PSMA PET to predict time to radiographic progression
Analysis will be conducted to evaluate whether changes in lesion uptake values predict time to radiographic progression. Time to radiographic progression will be defined as the number of days to confirmed radiographic progression using Prostate Cancer WorkingGroup 3 (PCWG3) criteria.
Measured: Baseline to 36 weeks
Correlate amount of intrinsic resistance on FDG and PSMA PET to predict time duration on treatment
Analysis will be conducted to evaluate whether changes in lesion uptake values predict duration of treatment. Duration of treatment will be defined as the time from treatment start, to treatment discontinuation (and reason for discontinuation) using PCWG3 criteria.
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start6 Mar 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Liu, MD, Principal investigator, University of Wisconsin, MadisonRobert Jeraj, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647564
- Sponsor's protocol ID
- 2022-0910
- Other IDs
- 2022-0910, A534260, SMPH/MEDICINE/HEM-ONC, NCI-2022-09580, Protocol Version 8/1/2026
- Status last verified
- Sep 2026
- First submitted
- 6 Dec 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CT Characterization of Treatment Resistance of AR-targeted Therapies in mCRPC
- ClinicalTrials.gov ID
- NCT05647564
- Acronym / sponsor ID
- 2022-0910
- Conditions
- Prostate Cancer
- Keywords
- androgen receptor targeted therapy, imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use different types of medical imaging to assess how lesions from advanced prostate cancer become resistant to second-generation AR-targeted therapy, and how the different types of imaging compare in that assessment. Participants in this study have advanced prostate cancer and are either scheduled to start a second-generation androgen receptor (AR) targeted therapy (such as enzalutamide, abiraterone, or apalutamide) or are already being treated with one. Participants can expect to be in the study for at least 9 months, and up to 2 years.
Detailed description
There are two groups, or cohorts, in this study. Participants are assigned to Cohort A if they have advanced prostate cancer and are scheduled to start a second-generation AR-targeted therapy (such as enzalutamide, abiraterone, darolutamide, or apalutamide) or PSMA directed radiotherapy (e.g. Lu177-PSMA radio-ligand therapy. 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrinsic Resistance Cohort (Cohort A) | Other | Diagnostic Test: F-fluorodeoxyglucose positron emission tomography (FDG PET), Diagnostic Test: prostate-specific membrane antigen positron emission tomography (PSMA PET)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 . |
| Acquired Resistance Cohort (Cohort B) | Other | Diagnostic Test: F-fluorodeoxyglucose positron emission tomography (FDG PET), Diagnostic Test: prostate-specific membrane antigen positron emission tomography (PSMA PET)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-fluorodeoxyglucose positron emission tomography (FDG PET)Imaging scan | Diagnostic test | Acquired Resistance Cohort (Cohort B), Intrinsic Resistance Cohort (Cohort A) |
| prostate-specific membrane antigen positron emission tomography (PSMA PET)Imaging scan | Diagnostic test | Acquired Resistance Cohort (Cohort B), Intrinsic Resistance Cohort (Cohort A) |
Primary outcome
Characterize intrinsic resistance based on FDG and PSMA PET through change in individual lesion update levels.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 progression
Time frame: Baseline to 36 weeks
Percentage and absolute changes in individual lesion update levels (ΔiSUVtotal) will be calculated.
3 secondary outcomes
Correlate amount of intrinsic resistance on FDG and PSMA PET to predict time to PSA progression
Time frame: Baseline to 36 weeks
Correlate amount of intrinsic resistance on FDG and PSMA PET to predict time to radiographic progression
Time frame: Baseline to 36 weeks
Correlate amount of intrinsic resistance on FDG and PSMA PET to predict time duration on treatment
Time frame: Up to 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenn Liu, MD principal investigator
University of Wisconsin, Madison
Robert Jeraj, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-fluorodeoxyglucose positron emission tomography (FDG PET) and prostate-specific membrane antigen positron emission tomography (PSMA PET) in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize intrinsic resistance based on FDG and PSMA PET through change in individual lesion update levels. (time frame: Baseline to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.