Clinical trial · Interventional
Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers
NCT03585114CI-TRIAL-00058440active not recruitingPhase 2ClinicalTrials.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)
Primary Objective: * To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria. Secondary Objectives: * To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans correlate with overall survival (OS) * To determine whether baseline SUVmax correlate with rPFS * To compare number of lesions detected with standard imaging at baseline and at the time of progression
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 |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [F-18] DCFPyL | Drug | — | UNRESOLVED |
| PET/CT imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PyL-PET
- description
- Male participants diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment will receive \[F-18\] DCFPyL PET/CT imaging before starting new treatment and after 6 weeks on treatment.
- interventionNames
- Drug: [F-18] DCFPyL
- Procedure: PET/CT imaging
Primary outcomes (1)
- measure
- Prevalence of changes in PyL PET imaging correlating with radiographic Progression-Free Survival (rPFS)
- timeFrame
- Baseline, Post-treatment (approximately 6 weeks)
- description
- To determine if changes in PyL PET/CT scans before and after 6 weeks on treatment is associated with stability of disease as measured by standard imaging.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of prostate cancer * Age ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) * Metastatic castrate resistant prostate cancer as defined by Prostate Cancer Working Group 3 * Eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel, cabazitaxel) for their disease * Ability to understand and willingness to sign a written informed consent document * Wiling 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 * Administration of another radioisotope within five physical half-lives of trial enrollment * Radiation or chemotherapy within 2 weeks prior to trial enrollment * Serum creatinine \> 3 times the upper limit of normal * Serum total bilirubin \> 3 times the upper limit of normal * Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \>5 times the upper limit of normal * Inadequate venous access
References
Publications (3)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. PMID 28055103
- BACKGROUNDSzabo Z, Mena E, Rowe SP, Plyku D, Nidal R, Eisenberger MA, Antonarakis ES, Fan H, Dannals RF, Chen Y, Mease RC, Vranesic M, Bhatnagar A, Sgouros G, Cho SY, Pomper MG. Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Mol Imaging Biol. 2015 Aug;17(4):565-74. doi: 10.1007/s11307-015-0850-8. PMID 25896814
- BACKGROUNDRowe SP, Macura KJ, Mena E, Blackford AL, Nadal R, Antonarakis ES, Eisenberger M, Carducci M, Fan H, Dannals RF, Chen Y, Mease RC, Szabo Z, Pomper MG, Cho SY. PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. Mol Imaging Biol. 2016 Jun;18(3):411-9. doi: 10.1007/s11307-016-0957-6. PMID 27080322