Phase 3
Completed N=208
Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
Prostate Cancer · Prostate adenocarcinoma · Prostate Cancer Recurrent · Prostate Cancer Metastatic
Source: ClinicalTrials.gov NCT03739684 ↗
Enrolled (actual)
208
Serious AEs
0.5%
Results posted
Jun 2021
Primary outcomePrimary: Correct Localization Rate (CLR) — 85.6; 87.0; 84.8 percentage of participants
Summary
This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correct Localization Rate (CLR) |
85.6; 87.0; 84.8 | — |
| SECONDARY Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results. |
131 | — |
| SECONDARY The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure) |
138.9; 136.7; -2.2; 78.5; 77.3; -1.2 | — |
| SECONDARY The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure) |
69.3; 65.1; -4.3 | — |
| SECONDARY Collection of Concomitant Medications (Safety Outcome Measure) |
103; 63; 36; 32; 31; 31 | — |
| SECONDARY Collection of Medical Procedures (Safety Outcome Measure) |
1; 1; 1; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Male >/= 18 years of age
- Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy
- Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of:
- Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (American Urological Association [AUA]); or
- Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic Radiology and Oncology [ASTRO]-Phoenix)
- Negative or equivocal findings for prostate cancer on conventional imaging performed as part of standard of care workup within 60 days prior to Day 1
- Life expectancy ≥6 months as determined by the investigator
- Able and willing to provide informed consent and comply with protocol requirements
Exclusion Criteria
- Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1
- Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer
- Treatment with ADT in the past 3 months of Day 1
- Receipt of investigational therapy for prostate cancer within 60 days of Day 1
- Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study
Data sourced from ClinicalTrials.gov (NCT03739684). 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.