Back to resultsPET/CT Characterization of Treatment Resistance
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
F-fluorodeoxyglucose positron emission tomography (FDG PET)
prostate-specific membrane antigen positron emission tomography (PSMA PET)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring androgen receptor targeted therapy, imaging
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, 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, 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: Visceral metastases (e.g. liver, lung or brain) 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
Sites / Locations
- University of WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Intrinsic Resistance Cohort (Cohort A)
Acquired Resistance Cohort (Cohort B)
Arm Description
Participants assigned to Cohort A have advanced prostate cancer and are scheduled to start a second-generation AR-targeted (such as enzalutamide, abiraterone, or apalutamide) or PSMA directed (e.g. Lu177-PSMA) therapies .
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Characterize acquired resistance at the time of progression
Percentage and absolute changes in individual lesion update levels (ΔiSUVtotal) will be calculated.
Secondary Outcome Measures
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
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.
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.
Full Information
NCT ID
NCT05647564
First Posted
December 6, 2022
Last Updated
August 15, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT05647564
Brief Title
PET/CT Characterization of Treatment Resistance
Official Title
PET/CT Characterization of Treatment Resistance of AR-targeted Therapies in mCRPC
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
androgen receptor targeted therapy, imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intrinsic Resistance Cohort (Cohort A)
Arm Type
Other
Arm Description
Participants assigned to Cohort A have advanced prostate cancer and are scheduled to start a second-generation AR-targeted (such as enzalutamide, abiraterone, or apalutamide) or PSMA directed (e.g. Lu177-PSMA) therapies .
Arm Title
Acquired Resistance Cohort (Cohort B)
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
F-fluorodeoxyglucose positron emission tomography (FDG PET)
Intervention Description
Imaging scan
Intervention Type
Diagnostic Test
Intervention Name(s)
prostate-specific membrane antigen positron emission tomography (PSMA PET)
Intervention Description
Imaging scan
Primary Outcome Measure Information:
Title
Characterize intrinsic resistance based on FDG and PSMA PET through change in individual lesion update levels.
Description
Changes in individual lesion update levels (ΔiSUVtotal) will be calculated. SUVtotal is a metric of activity, for which less activity is better.
Time Frame
Baseline to 12 weeks
Title
Characterize change in intrinsic resistance based on FDG and PSMA PET.
Description
Changes in individual lesion update levels (ΔiSUVtotal) will be calculated. SUVtotal is a metric of activity, for which a decrease in activity is better.
Time Frame
Baseline to 12 weeks
Title
Characterize change in intrinsic resistance based on FDG and PSMA PET.
Description
Changes in individual lesion update levels (ΔiSUVtotal) will be calculated. SUVtotal is a metric of activity, for which a decrease in activity is better.
Time Frame
12 weeks to 36 weeks
Title
Characterize change in intrinsic resistance based on FDG and PSMA PET.
Description
Changes in individual lesion update levels (ΔiSUVtotal) will be calculated. SUVtotal is a metric of activity, for which a decrease in activity is better.
Time Frame
Baseline to 36 weeks
Title
Characterize acquired resistance at the time of progression
Description
Percentage and absolute changes in individual lesion update levels (ΔiSUVtotal) will be calculated.
Time Frame
Baseline to 36 weeks
Secondary Outcome Measure Information:
Title
Correlate amount of intrinsic resistance on FDG and PSMA PET to predict time to PSA progression
Description
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
Time Frame
Baseline to 36 weeks
Title
Correlate amount of intrinsic resistance on FDG and PSMA PET to predict time to radiographic progression
Description
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.
Time Frame
Baseline to 36 weeks
Title
Correlate amount of intrinsic resistance on FDG and PSMA PET to predict time duration on treatment
Description
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.
Time Frame
Up to 36 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Men of all races and ethnic groups are eligible for this trial. Women are excluded given that prostate cancer is a male disease.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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, 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, 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:
Visceral metastases (e.g. liver, lung or brain)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cancer Connect
Phone
800-622-8922
Email
clinicaltrials@cancer.wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Liu, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer Connect
Phone
800-622-8922
Email
clinicaltrials@cancer.wisc.edu
First Name & Middle Initial & Last Name & Degree
Glenn Liu, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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PET/CT Characterization of Treatment Resistance
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