Imaging and Genomic Biomarkers to Predict Response in Prostate Cancer
Status
RECRUITING
Phase
EARLY_PHASE1
Age
≥ 18 Years
Enrollments
30Conditions
Prostate CancerDrugs
Androgen deprivation therapySummary
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.
Detailed Description
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Cancer Connect
- 800-622-8922
- [email protected]
Principal Investigator
- John Floberg, MD, PhD
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18
* Histologically confirmed adenocarcinoma of the prostate
* Cancer classified as high-risk or very high-risk by National Comprehensive Cancer Network (NCCN) criteria: Grade group ≥4, PSA >20, or primary tumor stage ≥T3a
* ECOG performance status 0-1
* Agreed to undergo EBRT, high dose rate (HDR) brachytherapy boost, and 6-36 months of ADT as part of standard of care therapy prior to study enrollment
* Able to undergo a HDR brachytherapy implant: Pre-radiation IPSS score ≤20 with or without medical management; prostate ≤60 cc as measured by MRI or ultrasound; no prior trans-urethral resection of prostate (TURP); and, median lobe extending into the bladder <1 cm
* No prior or concurrent malignancy unless disease-free for at least 5 years
Exclusion Criteria:
* Evidence of regional or distant metastatic disease on pre-treatment bone scan, pelvic MRI, and/or CT of the abdomen/pelvis
* Prior pelvic radiation therapy
Study Plan
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.
RADIATION:
External beam radiation therapyDescription:
Standard of care EBRTRADIATION:
Prostate brachytherapy boostDescription:
Standard of care BTXDRUG:
Androgen deprivation therapyDescription:
Standard of care ADTDIAGNOSTIC_TEST:
Positron emission tomography (PET)/magnetic resonance imaging (MRI)Description:
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.
Outcome Measures
Primary Outcome Measures
Imaging markers for mid-treatment response
Secondary Outcome Measures
Genomic signatures correlated with imaging response
Establish a correlation between PET imaging response and pathologic response
Establish a correlation between MRI imaging response and pathologic response
Imaging and genomic markers for prostate specific antigen (PSA) recurrence.
Evaluate blood-based biomarkers for treatment response.
Timeline
Last Updated
March 5, 2024Start Date
July 28, 2022Today
February 5, 2025Completion Date ( Estimated )
August 1, 2027
Sponsors of this trial
Lead Sponsor
University of Wisconsin, Madison
RECRUITING 
21 - 64 Years