Prostate CancerPhase 2/3OSPREYNCT02981368

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

A Phase 2/3 study testing 18F-DCFPyL Injection and PET/CT imaging in people with Prostate Cancer, run by Progenics Pharmaceuticals, Inc. at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: 18F-DCFPyL Injection and PET/CT imaging
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 385 participants
Where: 10 sitesin 2 countries
Study dates: Nov 2016to Jul 2018
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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]

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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.

Who cannot join

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.

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

United States8 sites

University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21287
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of Chicago
Chicago, Illinois, 60637
Yale University Department of Radiology and Biomedical Imaging
New Haven, Connecticut, 06520
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of California at San Francisco (UCSF) - Mt. Zion Hospital
San Francisco, California, 94143
Washington University Mallinckrodt Institute of Radilogy
St Louis, Missouri, 63110

Other trials in United States

Canada2 sites

Jewish General Hospital
Montreal, Quebec
Centre Hospitalier Universitaire de Quebec (CHUQ)
Québec

Other trials in Canada

About this study

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)

Cohort B is complete and no longer recruiting subjects.

Conditions: Prostate Cancer
Being tested: 18F-DCFPyL Injection, PET/CT imaging
Keywords: Diagnostic, Imaging, 2301, PET/CT, PyL, PSMA, radical prostatectomy, metastatic prostate cancer, recurrent prostate cancer
Medical subject headings: Prostatic Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

18F-DCFPyL InjectionDrug
Also called PyL
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
PET/CT imagingDiagnostic test
PET/CT imaging will be acquired 1-2 hours post-PyL injection

Study groups in NCT02981368
Study group	Role	What they receive
18F-DCFPyL Injection	Experimental	9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL Receives: Drug: 18F-DCFPyL Injection; Diagnostic Test: PET/CT imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
Measured: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
Measured: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Secondary outcomes (16)

Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)
Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.
Measured: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)
Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.
Measured: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)
Measured: Changes in ECG pre-drug dosing and within 1-2 hours post-dosing
Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Measured: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Measured: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Measured: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Measured: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)
Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition).
Measured: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging
The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results.
Measured: Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)
Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.
Measured: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)
Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.
Measured: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)
Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.
Measured: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)
Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.
Measured: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)
Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image.
Measured: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.
Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants
Measured: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.
Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants
Measured: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Jul 2018

First posted5 Dec 2016 (estimated)
Study startNov 2016
Primary completionJul 2018
Study completionJul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 385 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02981368
Sponsor's protocol ID: PyL 2301
Acronym: OSPREY
Status last verified: Aug 2021
First submitted: 22 Nov 2016
Last updated: 9 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Saperstein L, Rowe SP, Gorin MA, Pienta KJ, Siegel BA, Morris MJ, Baskaran S, Stambler N, DiPippo VA, Denes BS. Impact of Concomitant Hormone Therapy on the Diagnostic Performance of 18F-Piflufolastat PET/CT in Prostate Cancer Patients: A Sub-Group Analysis of OSPREY Cohort B. Prostate. 2025 Aug;85(11):1005-1015. doi: 10.1002/pros.24909. Epub 2025 May 4.
PubMed 40320701

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02981368
Acronym / sponsor ID: OSPREY / PyL 2301
Conditions: Prostate Cancer
Keywords: Diagnostic, Imaging, 2301, PET/CT, PyL, PSMA, radical prostatectomy, metastatic prostate cancer
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 385 participants (actual)
Lead sponsor: Progenics Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2016 (actual)
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 5 Dec 2016 (estimated)
Results: Posted 9 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Cohort B is complete and no longer recruiting subjects.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
18F-DCFPyL Injection	Experimental	Drug: 18F-DCFPyL Injection, Diagnostic Test: PET/CT imaging9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.
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]

Key exclusion criteria (7 listed)

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.
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
18F-DCFPyL InjectionAlso: PyLA single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL	Drug	18F-DCFPyL Injection
PET/CT imagingPET/CT imaging will be acquired 1-2 hours post-PyL injection	Diagnostic test	18F-DCFPyL Injection

Primary outcome

Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.

16 secondary outcomes

Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)
Time frame: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)
Time frame: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)
Time frame: Changes in ECG pre-drug dosing and within 1-2 hours post-dosing
Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)
Time frame: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging
Time frame: Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)
Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)
Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)
Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)
Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)
Time frame: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.
Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants
Time frame: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.
Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants
Time frame: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.

Results and safety

Results posted to the registry on 9 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Risk Prostate Cancer (Cohort A)	268	248
Recurrent or Metastatic Prostate Cancer (Cohort B)	117	102

Primary outcome: Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)

Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	High Risk Prostate Cancer (Cohort A) n = 252
Central Reader 1	97.9 (94.52 to 99.37)
Central Reader 2	98.9 (96.00 to 99.96)
Central Reader 3	96.3 (93.64 to 98.99)

Population analysed: The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.

Primary outcome: Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)

Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	High Risk Prostate Cancer (Cohort A) n = 252
Central Reader 1	41.9 (29.65 to 54.22)
Central Reader 2	30.6 (19.17 to 42.12)
Central Reader 3	40.3 (28.11 to 52.53)

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Risk Prostate Cancer (Cohort A)	1 of 268 (0.4%)	26 of 268 (9.7%)	0 of 268
Recurrent or Metastatic Prostate Cancer (Cohort B)	6 of 117 (5.1%)	1 of 117 (0.9%)	0 of 117

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40320701Saperstein L, Rowe SP, Gorin MA, Pienta KJ, Siegel BA, Morris MJ, Baskaran S, Stambler N, DiPippo VA, Denes BS. Impact of Concomitant Hormone Therapy on the Diagnostic Performance of 18F-Piflufolastat PET/CT in Prostate Cancer Patients: A Sub-Group Analysis of OSPREY Cohort B. Prostate. 2025 Aug;85(11):1005-1015. doi: 10.1002/pros.24909. Epub 2025 May 4.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael J Morris, MD study chair

Memorial Sloan Kettering Cancer Center

Kenneth J Pienta, MD principal investigator

Johns Hopkins University

10 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 18F-DCFPyL Injection and PET/CT imaging in people with Prostate Cancer, run by Progenics Pharmaceuticals, Inc. at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) (time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02981368, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.