Imaging and Genomic Biomarkers to Predict Response in Prostate Cancer

NCT ID: NCT05477823

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2027-08-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

EBRT + BTX + ADT, PET and MRI

Standard of care EBRT + BTX + ADT, with mid-treatment PET and MRI (or PET and CT) scans for research.

Group Type: EXPERIMENTAL

External beam radiation therapy

Intervention Type: RADIATION

Standard of care EBRT

Prostate brachytherapy boost

Intervention Type: RADIATION

Standard of care BTX

Androgen deprivation therapy

Intervention Type: DRUG

Standard of care ADT

Positron emission tomography (PET)/magnetic resonance imaging (MRI)

Intervention Type: 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.

Interventions

External beam radiation therapy

Standard of care EBRT

Intervention Type: RADIATION

Prostate brachytherapy boost

Standard of care BTX

Intervention Type: RADIATION

Androgen deprivation therapy

Standard of care ADT

Intervention Type: DRUG

Positron emission tomography (PET)/magnetic resonance imaging (MRI)

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Floberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

2022-0493

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol version 9/5/2025

Identifier Type: OTHER

Identifier Source: secondary_id

A533300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/HUMAN ONCOLOGY/HUMAN ONCO

Identifier Type: OTHER

Identifier Source: secondary_id

UW20099

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0493

Identifier Type: -

Identifier Source: org_study_id