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

NCT03739684 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PyL 3301
• Study Type: interventional
• Target: 208
• Locations: 2 countries
• Sites: 14

Brief Summary

This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Prostate Cancer Recurrent; Prostate Cancer Metastatic

Keywords

Positron emission tomography; biochemical recurrence; rising PSA; PET/CT; Diagnostic; Imaging; PSMA; radical prostatectomy; BCR

Outcome Measures

Primary Outcomes (1)

• Correct Localization Rate (CLR)

  The Correct Localization Rate (CLR) will be defined as percentage of participants with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT imaging and the composite truth standard. Within 60 days following PyL PET/CT imaging, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the PyL-suspected lesion(s) will be performed.

  Within 60 days following 18F-DCFPyL PET/CT imaging.

Secondary Outcomes (5)

• Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results.

  Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.

• The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)

  Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing.

• The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)

  Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing.

• Collection of Concomitant Medications (Safety Outcome Measure)

  From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.

• Collection of Medical Procedures (Safety Outcome Measure)

  From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.

Study Arms (1)

18F-DCFPyL Injection

EXPERIMENTAL

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

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

Interventions

18F-DCFPyL DRUG

A single dose of 9 mCi (333 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+
• Gender Eligibility Details: Only males subjects will be enrolled in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male \>/= 18 years of age
• Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy
• Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of:
• Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (American Urological Association \[AUA\]); or
• Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic Radiology and Oncology \[ASTRO\]-Phoenix)
• Negative or equivocal findings for prostate cancer on conventional imaging performed as part of standard of care workup within 60 days prior to Day 1
• Life expectancy ≥6 months as determined by the investigator
• Able and willing to provide informed consent and comply with protocol requirements

You may not qualify if:

• Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1
• Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer
• Treatment with ADT in the past 3 months of Day 1
• Receipt of investigational therapy for prostate cancer within 60 days of Day 1
• Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study

Sponsors & Collaborators

• Progenics Pharmaceuticals, Inc.: lead

Study Sites (14)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Tower Urology

Los Angeles, California, 90048, United States

Location

University of California San Francisco - Helen Diller Cancer Center

San Francisco, California, 94143, United States

Location

Stanford

Stanford, California, 94305, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University - Mallinckrodt Institute of Radiology

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Chu de Quebec - Universite Laval

Québec, G1R2J6, 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

• Jessica D Jensen

  Progenics Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 14, 2018
• Study Start: November 27, 2018
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: June 14, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); CA (1)