Clinical trial · Interventional
18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer
Phase 2 Study of 18F-DCFPyL Positron Emission Tomography (PET) in Men With Intermediate or High Risk Biochemically Recurrent Prostate Cancer
NCT04727736CI-TRIAL-00074061terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Intervention became FDA-approved
Summary
Brief summary (as posted)
This is an interventional, single group assignment, prospective nonrandomized, open label Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-DCFPyL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DCFPyL + PET imaging
- description
- Participants will receive a single dose of 18F-DCFPyL and undergo a PET imaging study. (The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.)
- interventionNames
- Drug: 18F-DCFPyL
Primary outcomes (1)
- measure
- Positive Predictive Value (PPV) (Per-patient)
- timeFrame
- Up to 12 months
- description
- Number of patients with true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without disease). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of prostate cancer * Biochemical recurrence was defined as a PSA of 0.2 or more ng/mL measured more than 6 weeks after prostatectomy or a PSA of 2 or more ng/mL rise above nadir following radiation therapy (ASTRO Phoenix consensus definition) * Age ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) * Ability to understand and willingness to sign a written informed consent document * Willing to comply with clinical trial instructions and requirements Exclusion Criteria: * History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin * Presence of prostate brachytherapy implants unless approved by the PI * Administration of another radioisotope within five physical half-lives of trial enrollment * Radiation or chemotherapy within 2 weeks prior to trial enrollment * Estimated glomerular filtration rate (eGFR) \< 15 ml/mmol * Serum total bilirubin \> 3 times the upper limit of normal * Aspartate transaminase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal * Inadequate venous access * Claustrophobia or any other condition that would preclude PET imaging * Patients must not be receiving ADT except per criteria directly below. Patients who received in the past must have a serum testosterone that is recovered to at least 100 ng/dL. * Patients who have been on ADT +/- novel hormonal agent (NHA) and developed M0 CRPC
References
Publications (0)
Data not yet available
No reference posted for this study.