Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer

Conditions
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Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Recurrent, Prostate Cancer Metastatic

Intervention / Treatment
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* Drug: 18F-DCFPyL
* Diagnostic Test: PET/CT Imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-DCFPyL Injection<br>9 mCi (333 MBq) IV injection of 18F-DCFPyL | Drug: 18F-DCFPyL<br>* A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL<br>* Other names: PyL;Diagnostic Test: PET/CT Imaging<br>* PET/CT imaging will be acquired 1-2 hours post-PyL injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct Localization Rate (CLR) | The Correct Localization Rate (CLR) will be defined as percentage of participants with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT imaging and the composite truth standard. Within 60 days following PyL PET/CT imaging, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the PyL-suspected lesion(s) will be performed. | Within 60 days following 18F-DCFPyL PET/CT imaging. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results. | The change in the intended prostate cancer treatment plan will be based on Medical Management Questionnaires completed prior to and after 18F-DCFPyL PET/CT imaging. | Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging. | 
| The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure) | The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics. | Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing. | 
| The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure) | The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics. | Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing. | 
| Collection of Concomitant Medications (Safety Outcome Measure) | Medications will be coded using the WHO drug dictionary. The medications are summarized by ATC level 4 category and presented as number and percentage of participants. Results are presented where the percentage of participants within an ATC level 4 category is >5.0. | From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing. | 
| Collection of Medical Procedures (Safety Outcome Measure) | Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant. | From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron emission tomography, biochemical recurrence, rising PSA, PET/CT, Diagnostic, Imaging, PSMA, radical prostatectomy, BCR