Clinical trial · Interventional
Evaluation of PSMA-based PET as an Imaging Biomarker in Prostate Cancer
Evaluation of PSMA-based PET as an Imaging Biomarker of Androgen Receptor Signaling in High-Risk Localized and Locally Advanced Prostate Cancer
NCT02420977CI-TRIAL-00087400completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This research is being done to see if an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer before surgery.
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 |
|---|---|---|---|
| Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pelvic DCFPyL PET-MRI fusion or PET/MRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DCFPyL PET-MRI fusion or PET/MRI
- description
- * Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months of ADT * Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months
- interventionNames
- Drug: Pelvic DCFPyL PET-MRI fusion or PET/MRI
Primary outcomes (1)
- measure
- Response rate differences
- timeFrame
- baseline and after 2-3 months
- description
- To compare the detection , sextant localization and response of DCFPyL PET-MRI fusion or PET/MRI before and after 2-3 months of ADT in men with biopsy-positive high-risk localized or locally advanced prostate cancer.
Secondary outcomes (5)
- measure
- Biomarker changes
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT. * Key inclusion criteria (the entire list of inclusion and exclusion criteria will appear later in section 4 of the protocol) * Newly diagnosed prostate cancer pathologically proven by prostate biopsy * Prostate biopsy histology grade ≥ Gleason 8-10 * Patients considered as candidates for and medically fit to undergo radiation and ADT * At least 10 days after most recent prostate biopsy Exclusion Criteria: * Prior pelvic external beam radiation therapy or brachytherapy * Chemotherapy for prostate cancer * Hormone deprivation therapy * Investigational therapy for prostate cancer * Hemorrhagic cystitis or active prostatitis
References
Publications (0)
Data not yet available
No reference posted for this study.