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

NCT02981368 | Completed Phase 2 Results

• 1 other identifier: PyL 2301
• Study Type: interventional
• Target: 385
• Locations: 2 countries
• Sites: 10

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  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)

  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)

  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 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 at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.

Study Arms (1)

18F-DCFPyL Injection

EXPERIMENTAL

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

Drug: 18F-DCFPyL Injection; Diagnostic Test: PET/CT imaging

Interventions

18F-DCFPyL Injection DRUG

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

Also known as: PyL

18F-DCFPyL Injection

PET/CT imaging DIAGNOSTIC_TEST

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

18F-DCFPyL Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Progenics Pharmaceuticals, Inc.: lead

Study Sites (10)

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

San Francisco, California, 94143, United States

Location

Yale University Department of Radiology and Biomedical Imaging

New Haven, Connecticut, 06520, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Washington University Mallinckrodt Institute of Radilogy

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

Centre Hospitalier Universitaire de Quebec (CHUQ)

Québec, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David Myl
• Organization: Lantheus Medical Imaging / Progenics Pharmaceuticals

david.myl@lantheus.com

914-582-1120

Study Officials

• Michael J Morris, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

• Kenneth J Pienta, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 5, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 9, 2021
• Results First Posted: August 9, 2021

Record last verified: 2021-08

Locations

US (8); CA (2)