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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

18F-DCFPyL Injection

PET/CT imaging

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Diagnostic, Imaging, 2301, PET/CT, PyL, PSMA, radical prostatectomy, metastatic prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

University of California at San Francisco (UCSF) - Mt. Zion Hospital
Yale University Department of Radiology and Biomedical Imaging
University of Chicago
Johns Hopkins University
Dana Farber Cancer Institute
University of Michigan Cancer Center
Washington University Mallinckrodt Institute of Radilogy
Memorial Sloan Kettering Cancer Center
Jewish General Hospital
Centre Hospitalier Universitaire de Quebec (CHUQ)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DCFPyL Injection

Arm Description

9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Outcomes

Primary Outcome Measures

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.

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)

Secondary Outcome Measures

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.

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.

Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)

Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)

Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)

Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)

Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)

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).

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.

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.

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.

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)

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)

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)

Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants

Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants

Full Information

NCT ID

NCT02981368

First Posted

November 22, 2016

Last Updated

August 6, 2021

Sponsor

Progenics Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02981368

Brief Title

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

Acronym

OSPREY

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 Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

November 2016 (Actual)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Progenics Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Diagnostic, Imaging, 2301, PET/CT, PyL, PSMA, radical prostatectomy, metastatic prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

385 (Actual)

8. Arms, Groups, and Interventions

Arm Title

18F-DCFPyL Injection

Arm Type

Experimental

Arm Description

9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Intervention Type

Drug

Intervention Name(s)

18F-DCFPyL Injection

Other Intervention Name(s)

PyL

Intervention Description

A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Intervention Type

Diagnostic Test

Intervention Name(s)

PET/CT imaging

Intervention Description

PET/CT imaging will be acquired 1-2 hours post-PyL injection

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Title

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)

Description

Time Frame

Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Secondary Outcome Measure Information:

Title

Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)

Description

Time Frame

From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).

Title

Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)

Description

Time Frame

From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).

Title

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

Title

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.

Title

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.

Title

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.

Title

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.

Title

Description

Time Frame

Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.

Title

Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging

Description

Time Frame

Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken

Title

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)

Description

Time Frame

Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Title

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)

Description

Time Frame

Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Title

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)

Description

Time Frame

Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Title

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)

Description

Time Frame

Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Title

Description

Time Frame

Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.

Title

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.

Title

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.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael J Morris, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Kenneth J Pienta, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California at San Francisco (UCSF) - Mt. Zion Hospital

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Yale University Department of Radiology and Biomedical Imaging

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

University of Michigan Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Washington University Mallinckrodt Institute of Radilogy

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Jewish General Hospital

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Centre Hospitalier Universitaire de Quebec (CHUQ)

City

Quebec

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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