Clinical trial · Interventional
Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer
Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer - an Interscan Variability and Intraobserver Agreement Study
NCT03793543CI-TRIAL-00055518completedPhase 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)
In this study, the investigators intend to validate 18F-DCFPyL test-retest reproducibility in metastatic lesions, in order to investigate whether it serves as a reliable response assessment tool, both to interpret existing studies and to design future longitudinal trials.
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 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DCFPyL Injection
- description
- 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
- interventionNames
- Drug: 18F-DCFPyL Injection
Primary outcomes (2)
- measure
- Change in number of metastatic lesions detected on on 18F-DCFPyL PET/CT from baseline
- timeFrame
- Change from baseline to up to 4 weeks
- description
- Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT at baseline with a subsequent near-term 18F-DCFPyL PET/CT scan.
- measure
- Test the intraobserver agreement as assessed by percentage of scans that are read the same on second read
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willing and able to provide written informed consent * History of histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology * Patients with metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) with evidence of metastatic disease on conventional imaging with CT or bone scan. * Prior docetaxel-based chemotherapy is permitted * Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following and has not initiated a new therapy after determination of progression: Rising PSA over a minimum 1-week interval and/or radiographic progression in soft tissue and bone metastases (combination of bony and soft tissue metastases) * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Exclusion Criteria: * Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection * Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT * Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT * Administered oral contrast medium ≤120 hours prior to the date of study PET/CT * Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
References
Publications (2)
- DERIVEDWerner RA, Lutje S, Habacha B, Bundschuh L, Higuchi T, Buck AK, Kosmala A, Lapa C, Essler M, Lodge MA, Pienta KJ, Eisenberger MA, Markowski MC, Gorin MA, Pomper MG, Rowe SP, Bundschuh RA. Test-retest repeatability of organ uptake on PSMA-targeted 18 F-DCFPyL PET/CT in patients with prostate cancer. Prostate. 2023 Sep;83(12):1186-1192. doi: 10.1002/pros.24577. Epub 2023 May 21. PMID 37211963
- DERIVEDWerner RA, Habacha B, Lutje S, Bundschuh L, Higuchi T, Hartrampf P, Serfling SE, Derlin T, Lapa C, Buck AK, Essler M, Pienta KJ, Eisenberger MA, Markowski MC, Shinehouse L, AbdAllah R, Salavati A, Lodge MA, Pomper MG, Gorin MA, Bundschuh RA, Rowe SP. High SUVs Have More Robust Repeatability in Patients with Metastatic Prostate Cancer: Results from a Prospective Test-Retest Cohort Imaged with 18F-DCFPyL. Mol Imaging. 2022 Feb 23;2022:7056983. doi: 10.1155/2022/7056983. eCollection 2022. PMID 35283693