Clinical trial · Interventional
PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer
NCT03232164CI-TRIAL-00083631completedEarly 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)
The overall goal of this research is to validate and develop a non-invasive imaging biomarker of prostate cancer detection, progression, and recurrence. Development of such a biomarker may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing for selection of an appropriate risk adaptive therapy.
Conditions
Conditions (2)
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 |
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-DCFPyL PET | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DCFPyL PET
- description
- Four separate substudies evaluating 18F-DCFPyL PET imaging of prostate cancer in four prostate cancer clinical scenarios under the following subheadings: (1) primary prostate cancer, (2) biochemical recurrence post-prostatectomy prior to radiation therapy, (3) androgen-resistant metastatic disease and (4) detection of clinically significant prostate cancer in low to intermediate risk primary prostate cancer
- interventionNames
- Drug: 18F-DCFPyL PET
Primary outcomes (4)
- measure
- 18F-DCFPyL PSMA-based PET and multi-parametric MRI with DWI for Sub-Study 1: Primary Prostate Cancer
- timeFrame
- one study visit (up to 3.5 hours)
- description
- To evaluate the performance of 18F-DCFPyL PSMA-based PET and multi-parametric MRI (MP-MRI) with DWI (Diffusion Weighted Imaging) and gadolinium DCE (Dynamic Contrast Enhanced) using a dedicated PET/MRI scanner to detect clinically significant larger volume high-grade primary prostate cancer based on prostatectomy step-section pathology correlation.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate cancer pathologically proven by prostate biopsy (newly diagnosed for Sub-Study 1 and 4) * Prostate biopsy histology grade ≥ Gleason 1, 6, 3+4, or 4+3; positive biopsy \>2 cores * Any PSA permitted * Two consecutive rising PSA values (Sub-Study 3 only) * Castrate-levels of testosterone - total testosterone \< 50 ng/dL (Sub-Study 3 only) * Patients considered as candidates for and medically fit to undergo prostatectomy * At least 7 days after most recent prostate biopsy * Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI, ultrasound or other PET modalities (Sub-Study 3 only) * New diagnosis of prostate cancer undergoing additional biopsy evaluation (Sub--Study 4 only) * Karnofsky performance status of at least 70 (Sub-Study 4 only) * General health and anatomy suitable to undergo transrectal ultrasound-MRI fusion biopsy of the identified lesions and standard 12 core sextent biopsy (Sub-Study 4 only) Exclusion Criteria: * Prior pelvic external beam radiation therapy or brachytherapy * Chemotherapy for prostate cancer * Androgen deprivation therapy for prostate cancer * Investigational therapy for prostate cancer (Sub-Study 3 Only) * Unable to lie flat during or tolerate PET/CT * Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer. * No prostatectomy scheduled more than 12 hours post imaging (Sub-Study 1 only) * Serum creatinine \> 2 time the upper limit of normal * Total bilirubin \> 3 times the upper limit of normal * Liver Transaminases \> 5 times the upper limit of normal
References
Publications (0)
Data not yet available
No reference posted for this study.