Clinical trial NCT05477823: Imaging and Genomic Biomarkers to Predict Response in Prostate Cancer
Official title: Pilot Study to Identify Radiogenomic Biomarkers to Predict Early Treatment Response to Androgen Deprivation Therapy and Radiation Therapy in High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

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

Primary outcomes:
measure: Imaging markers for mid-treatment response
timeFrame: Mid-treatment (approximately 3 months into treatment)
Secondary outcomes:
measure: Genomic signatures correlated with imaging response
timeFrame: Baseline and mid-treatment (approximately 3 months into treatment)
measure: Establish a correlation between PET imaging response and pathologic response
timeFrame: Baseline and mid-treatment (approximately 3 months into treatment)
measure: Establish a correlation between MRI imaging response and pathologic response
timeFrame: Baseline and mid-treatment (approximately 3 months into treatment)
measure: Imaging and genomic markers for prostate specific antigen (PSA) recurrence.
timeFrame: Baseline, 3 months post therapy, every 6 months for 5 years
measure: Evaluate blood-based biomarkers for treatment response.
timeFrame: Baseline and mid-treatment (approximately 3 months into treatment)
Other outcomes:
measure: Changes in cancer gene expression during therapy
timeFrame: Baseline and mid-treatment (approximately 3 months into treatment)
measure: Prognostic significance of higher order radioman metrics
timeFrame: Baseline and mid-treatment (approximately 3 months into treatment)
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: John Floberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: