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

A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)

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.

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate.
2. 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:

1. 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.
2. 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.