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

Progenics Pharmaceuticals

Status and phase

Completed

Phase 3

Phase 2

Conditions

Prostate Cancer

Treatments

Diagnostic Test: PET/CT imaging

Drug: 18F-DCFPyL Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT02981368

PyL 2301

Details and patient eligibility

About

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.

Enrollment

385 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.