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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-0493 | Other Identifier | UW Madison | |
| Protocol version 9/5/2025 | Other Identifier | UW Madison | |
| A533300 | Other Identifier | UW Madison | |
| SMPH/HUMAN ONCOLOGY/HUMAN ONCO | Other Identifier | UW Madison | |
| UW20099 | Other Identifier | OnCore ID |
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The purpose of this study is to evaluate the imaging and gene expression biomarkers in prostate cancer. Participants have high-risk prostate cancer and have indicated they will undergo external beam radiation therapy, brachytherapy, and androgen deprivation therapy (EBRT+BTX+ADT). Participants can expect to be in this study for up to 5 years.
This is a pilot study to prospectively investigate potential predictive imaging and genomic biomarkers for patients with high-risk prostate cancer treated with standard of care EBRT + BTX + ADT. The primary imaging modalities that will be evaluated will be PSMA positron emission tomography (PET) and multi-parametric magnetic resonance imaging (MRI). Pre-treatment PET/MRI scans will also be obtained as part of standard of care prior to study enrollment. Response will be assessed on a mid-treatment PET/MRI scan obtained for research purposes after completion of EBRT but prior to brachytherapy boost. PET/CT (computerized tomography) may be used instead if PET/MRI is not technically possible. Imaging response will be compared to pathology from image-directed prostate biopsies taken at the time of the brachytherapy boost. The primary genomic marker that will be evaluated is a clinically available gene-expression array, Decipher, that will be obtained as part of standard of care prior to study enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBRT + BTX + ADT, PET and MRI | Experimental | Standard of care EBRT + BTX + ADT, with mid-treatment PET and MRI (or PET and CT) scans for research. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External beam radiation therapy | Radiation | Standard of care EBRT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Imaging markers for mid-treatment response | Evaluate prostate specific membrane antigen (PSMA) PET/MRI for imaging biomarkers that predict mid-treatment response to ADT and EBRT to identify participants at risk for poor response to radiation therapy and ADT. | Mid-treatment (approximately 3 months into treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Genomic signatures correlated with imaging response | Determine if the Decipher and PORTOS genomic scores (high vs low) and basal/luminal genomic subtypes are correlated with change in PSMA standardized uptake value (SUV) pre-to-mid-treatment. | Baseline and mid-treatment (approximately 3 months into treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cancer gene expression during therapy | Evaluate changes in gene expression from pre- to mid-treatment, and their association with response to therapy. | Baseline and mid-treatment (approximately 3 months into treatment) |
| Prognostic significance of higher order radioman metrics |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Floberg, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| Prostate brachytherapy boost |
| Radiation |
Standard of care BTX |
|
| Androgen deprivation therapy | Drug | Standard of care ADT |
|
| Positron emission tomography (PET)/magnetic resonance imaging (MRI) | Diagnostic Test | Pelvic PET scanning with tracer will take approximately 45 minutes. This will be followed by the injection of a contrast agent followed by whole body PET/MRI scanning which will take approximately 30 minutes. |
|
| Establish a correlation between PET imaging response and pathologic response |
PET images will be assessed for response using change in SUV in order to establish a correlation between imaging response and pathologic response to ADT and EBRT on a lesion-by-lesion basis. Pathologic response will be evaluated considering change in percent core involvement, prostate cancer epithelial/stromal (E/S) ratio, PSMA, CC3 and Ki67 expression. Concordance will be assessed using the Kappa statistic. |
| Baseline and mid-treatment (approximately 3 months into treatment) |
| Establish a correlation between MRI imaging response and pathologic response | MR images will be assessed for response using change in apparent diffusion coefficient (ADC) in order to establish a correlation between imaging response and pathologic response to ADT and EBRT on a lesion-by-lesion basis. Pathologic response will be evaluated as described in Outcome 3. Concordance will be assessed using the Kappa statistic. | Baseline and mid-treatment (approximately 3 months into treatment) |
| Imaging and genomic markers for prostate specific antigen (PSA) recurrence. | Determine if imaging and genomic markers that predict for mid-treatment pathologic response also predict PSA recurrence. | Baseline, 3 months post therapy, every 6 months for 5 years |
| Evaluate blood-based biomarkers for treatment response. | Messenger RNA from circulating tumor cells (CTCs) will be extracted to determine if presence of androgen receptor variants and a neuroendocrine prostate cancer signature (a score based upon the expression of a set of genes) is correlated with pathologic response (determined as outlined in Outcome 3). | Baseline and mid-treatment (approximately 3 months into treatment) |
Higher order radiomic metrics (e.g. measures of PET lesion heterogeneity obtained using open-source radiomic software) will be assessed as potential predictive markers for pathologic treatment response (measured as outlined in Outcome 3) to ADT and EBRT. |
| Baseline and mid-treatment (approximately 3 months into treatment) |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000726 | Androgen Antagonists |
| D049268 | Positron-Emission Tomography |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
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