Imaging and Genomic Biomarkers to Predict Response in Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2027-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Androgens

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 18 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 ≤15 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