Clinical trial · Interventional
Prostate Cancer Patient Management With 18F-DCFPyL PET/CT
Differences in Optimal Prostate Cancer Patient Management as Proposed by a Panel of Experts Before and After 18F-DCFPyL PET/CT
- 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 is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.
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 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DCFPyL PET/CT
- description
- 18F-DCFPyL PET/CT Scan
- interventionNames
- Diagnostic Test: 18F-DCFPyL PET/CT
Primary outcomes (1)
- measure
- Differences in optimal clinical management
- timeFrame
- 30 days
- description
- Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.
Secondary outcomes (2)
- measure
- Scan positivity fraction in BCR by PSA.
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male sex * Age 18 years or older * Previously diagnosed with prostate cancer, under referring physician's care * ECOG performance status 0 - 3, inclusive * Able to understand and provide written informed consent * Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection Cohort A - High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following: * Gleason score \> 7 * Serum PSA \> 15 ng/ml * T stage of T3 or greater on TNM staging * Equivocal/inconclusive conventional staging such as CT, MRI or bone scan * Clinical suspicion of advance stage disease (e.g. bone pain) Cohort B - Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer. Exclusion Criteria: * Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) * Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter) * Patients with unmanageable claustrophobia
References
Publications (0)
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