Using imaging and gene markers to predict prostate cancer treatment response
Pilot Study to Identify Radiogenomic Biomarkers to Predict Early Treatment Response to Androgen Deprivation Therapy and Radiation Therapy in High Risk Prostate Cancer
This study is testing if special imaging and gene markers can help predict how well standard treatments work for men with high-risk prostate cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05477823 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate imaging and genomic biomarkers in patients with high-risk prostate cancer undergoing standard treatments, including external beam radiation therapy, brachytherapy, and androgen deprivation therapy. Participants will receive pre-treatment imaging scans using PSMA PET and multi-parametric MRI, followed by mid-treatment scans to assess response. The study will also analyze gene expression using the Decipher array to correlate imaging results with pathology from biopsies taken during treatment. The overall goal is to identify predictive markers that can guide treatment decisions.
Who should consider this trial
Good fit: Ideal candidates are adult males aged 18 and older with histologically confirmed high-risk or very high-risk prostate cancer.
Not a fit: Patients with evidence of metastatic disease or those who have received prior pelvic radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with high-risk prostate cancer.
How similar studies have performed: Other studies have explored imaging and genomic biomarkers in cancer treatment, showing promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madison, Wisconsin
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: John Floberg, MD, PhD — University of Wisconsin, Madison
- Study coordinator: Cancer Connect
- Email: clinicaltrials@cancer.wisc.edu
- Phone: 800-622-8922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.