Imaging and Genomic Biomarkers to Predict Response in Prostate Cancer

NCT05477823 | Active Not Recruiting Early Phase 1 DMC FDA Drug FDA Device

• 5 other identifiers: 2022-0493Protocol version 9/5/2025A533300SMPH/HUMAN ONCOLOGY/HUMAN ONCOUW20099
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Genomic signatures correlated with imaging response

  Baseline and mid-treatment (approximately 3 months into treatment)

• Establish a correlation between PET imaging response and pathologic response

  Baseline and mid-treatment (approximately 3 months into treatment)

• Establish a correlation between MRI imaging response and pathologic response

  Baseline and mid-treatment (approximately 3 months into treatment)

• Imaging and genomic markers for prostate specific antigen (PSA) recurrence.

  Baseline, 3 months post therapy, every 6 months for 5 years

• Evaluate blood-based biomarkers for treatment response.

  Baseline and mid-treatment (approximately 3 months into treatment)

Other Outcomes (2)

• Changes in cancer gene expression during therapy

  Baseline and mid-treatment (approximately 3 months into treatment)

• Prognostic significance of higher order radioman metrics

  Baseline and mid-treatment (approximately 3 months into treatment)

Study Arms (1)

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 therapy; Radiation: Prostate brachytherapy boost; Drug: Androgen deprivation therapy; Diagnostic Test: Positron emission tomography (PET)/magnetic resonance imaging (MRI)

Interventions

External beam radiation therapy RADIATION

Standard of care EBRT

EBRT + BTX + ADT, PET and MRI

Prostate brachytherapy boost RADIATION

Standard of care BTX

EBRT + BTX + ADT, PET and MRI

Androgen deprivation therapy DRUG

Standard of care ADT

EBRT + BTX + ADT, PET and MRI

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.

EBRT + BTX + ADT, PET and MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• John Floberg, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 28, 2022
• Study Start: March 8, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)