Clinical trial · Interventional
Imaging and Genomic Biomarkers to Predict Response in Prostate Cancer
Pilot Study to Identify Radiogenomic Biomarkers to Predict Early Treatment Response to Androgen Deprivation Therapy and Radiation Therapy in High Risk Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen deprivation therapy | Drug | — | UNRESOLVED |
| External beam radiation therapy | Radiation | — | UNRESOLVED |
| Positron emission tomography (PET)/magnetic resonance imaging (MRI) | Diagnostic Test | — | UNRESOLVED |
| Prostate brachytherapy boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EBRT + BTX + ADT, PET and MRI
- description
- Standard of care EBRT + BTX + ADT, with mid-treatment PET and MRI (or PET and CT) scans for research.
- interventionNames
- Radiation: External beam radiation therapy
- Radiation: Prostate brachytherapy boost
- Drug: Androgen deprivation therapy
- Diagnostic Test: Positron emission tomography (PET)/magnetic resonance imaging (MRI)
Primary outcomes (1)
- measure
- Imaging markers for mid-treatment response
- timeFrame
- Mid-treatment (approximately 3 months into treatment)
- description
- 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.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available