Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer (OSPREY)
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| ClinicalTrials.gov Identifier: NCT02981368 |
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Recruitment Status :
Active, not recruiting
First Posted : December 5, 2016
Last Update Posted : July 16, 2018
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Sponsor:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: 18F-DCFPyL Injection | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 377 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY) |
| Study Start Date : | November 2016 |
| Estimated Primary Completion Date : | August 2018 |
| Estimated Study Completion Date : | August 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Prostate cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: 18F-DCFPyL Injection
9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
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Drug: 18F-DCFPyL Injection
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
Other Name: PyL |
Primary Outcome Measures :
- Sensitivity and Specificity of 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer within the pelvic lymph nodes relative to histopathology in Cohort A [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken. Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. ]
Secondary Outcome Measures :
- Changes in clinical laboratory values [Safety and Tolerability] [ Time Frame: From time of screening until pre-surgery/biopsy (within 28 days post-study drug dosing) ]
- Changes in ECG related to 18F-DCFPyL administration [Safety and Tolerability] [ Time Frame: Changes in ECG pre-drug dosing and within 1-2 hours post-dosing ]
- Incidence of Treatment emergent adverse events [Safety and Tolerability] [ Time Frame: From study drug dosing until 10 days ]
- Sensitivity of 18F-DCFPyL PET/CT imaging to detect prostate cancer within sites of metastasis or local recurrence relative to histopathology in Cohort B [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken. Within 28 days of imaging, biopsy will occur. ]
- Lesion count in different locations as detected by 18F-DCFPyL vs. conventional imaging [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken ]
- Positive and negative predictive values (PPV and NPV) of 18F-DCFPyL PET/CT imaging to predict prostate cancer within the prostate gland and lymph nodes in Cohort A [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken. Within 28 days of imaging, radical prostatecomy with pelvic lymph node dissection will occur. ]
- PPV of 18F-DCFPyL PET/CT imaging to predict prostate cancer within sites of local recurrence and other metastatic lesions in Cohort B [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken. Within 28 days of imaging, biopsy will occur. ]
- Peak plasma concentration (Cmax) of 18F-DCFPyL in subset of patients [ Time Frame: At 0-8 hours post- dosing ]Summary statistics by timepoint
- Area under the plasma concentration vs time curve (AUC) of 18F-DCFPyL in subset of patients [ Time Frame: At 0-8 hours post- dosing ]Summary statistics by timepoint
Other Outcome Measures:
- Exploratory analysis of 18F-DCFPyL uptake in different lesion locations [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken ]
- Pre-specified post hoc retrospective analysis of changes to clinical management plan based on central expert panel review of clinical and radiographic subject data before and after 18F-DCFPyL PET/CT scan results [ Time Frame: After enrollment is complete ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981368
Locations
| United States, California | |
| University of California at San Francisco (UCSF) - Mt. Zion Hospital | |
| San Francisco, California, United States, 94143 | |
| United States, Connecticut | |
| Yale University Department of Radiology and Biomedical Imaging | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Missouri | |
| Washington University Mallinckrodt Institute of Radilogy | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Canada, Quebec | |
| Jewish General Hospital | |
| Montreal, Quebec, Canada | |
| Canada | |
| Centre Hospitalier Universitaire de Quebec (CHUQ) | |
| Quebec, Canada | |
Sponsors and Collaborators
Progenics Pharmaceuticals, Inc.
Investigators
| Study Chair: | Michael J Morris, MD | Memorial Sloan Kettering Cancer Center | |
| Principal Investigator: | Kenneth J Pienta, MD | Johns Hopkins University |
| Responsible Party: | Progenics Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT02981368 History of Changes |
| Other Study ID Numbers: |
PyL 2301 |
| First Posted: | December 5, 2016 Key Record Dates |
| Last Update Posted: | July 16, 2018 |
| Last Verified: | July 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Progenics Pharmaceuticals, Inc.:
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Diagnostic Imaging 2301 PET/CT PyL |
PSMA radical prostatectomy metastatic prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |