Phase 3
Completed N=385
Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT02981368 ↗Enrolled (actual)
385
Serious AEs
1.8%
Results posted
Aug 2021
Primary outcomePrimary: Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) — 97.9; 98.9; 96.3 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Cohort B).
Cohort B is complete and no longer recruiting subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) |
97.9; 98.9; 96.3 | — |
| PRIMARY Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) |
41.9; 30.6; 40.3 | — |
| SECONDARY Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) |
26; 0; 12; 0; 0; 0 | — |
| SECONDARY Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) |
3; 0; 3; 0; 0; 0 | — |
| SECONDARY Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) |
159; 155; 55; 51; 101; 109 | — |
| SECONDARY Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) |
133.7; 133.6; 133.7; 132.1; 0.1; -1.3 | — |
| SECONDARY Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) |
70.7; 71.3; 66.4; 67.0; -4.4; -4.6 | — |
| SECONDARY Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) |
16.7; 17.3; 16.6; 17.3; -0.1; 0.0 | — |
| SECONDARY Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) |
36.58; 36.56; 36.50; 36.59; -0.08; 0.03 | — |
| SECONDARY Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) |
98.6; 95.8; 92.9 | — |
| SECONDARY Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging |
239; 234; 247; 237; 37; 22 | 0.1097 |
| SECONDARY Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) |
100.0; 100.0; 100.0 | — |
| SECONDARY Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) |
0; 0; 0 | — |
| SECONDARY Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) |
86.7; 90.5; 78.1 | — |
| SECONDARY Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) |
83.8; 81.4; 83.2 | — |
| SECONDARY Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) |
81.2; 81.9; 87.8 | — |
| SECONDARY Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants |
0.43 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants |
0.82 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed adenocarcinoma of the prostate.
- Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
Cohort A Only:
- At least high risk prostate cancer defined by NCCN Guidelines Version 3.2016 (clinical stage ≥T3a or PSA >20 ng/mL or Gleason score ≥8).
- Scheduled or planned radical prostatectomy with PLND.
Cohort B Only: [Enrollment is complete; No longer recruiting subjects]
- Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), whole-body bone scan (99m-Tc-MDP or Na-18F) within 4 weeks of enrollment.
- If prior treatment with radiation or ablative therapy, evidence of recurrence outside the confines of prior treated site(s) is needed.
- Scheduled or planned percutaneous biopsy of at least one amenable lesion.
Exclusion Criteria
- Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five physical half-lives, or any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.
- Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
Cohort A Only:
- Patients with prior androgen deprivation therapy or any investigational neoadjuvant agent or intervention
Cohort B Only: [Enrollment is Complete; No longer recruiting subjects]
- Prior radiation or ablative therapy to intended site of biopsy, if within the prostate bed
- Initiation of new therapy for recurrent and/or progressive metastatic disease since radiographic documentation of recurrence/progression.
Data sourced from ClinicalTrials.gov (NCT02981368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.