Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer

NCT03976843 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 19010419-C-0104
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 6

Brief Summary

Background: People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery. Objective: To test if a PET/CT scan before the prostate gland is removed can predict if prostate cancer will return. Also, to test if this approach is better or worse than the usual approach for prostate cancer. Eligibility: Men ages 18 and older with prostate cancer that appears to be contained within the prostate but is at risk of having spread Design: Participants will be screened with:

• Medical history
• Blood tests
• CT and MRI scans: Participants will lie in a machine. The machine will take pictures of the body.
• Bone scan Participants will have a radiotracer injected into a vein. They will have a PET/CT scan of their whole body 60-90 minutes later. During the scan, they will lie on their back and stay still. Within 60 days after the scan, participants will have surgery. This will remove the prostate gland and lymph nodes around it. Some tissue will be used for genetic testing. If the PET/CT scan suggests the cancer has spread, participants may need to have another biopsy within 60 days after the scan. After surgery, participants will have follow-up visits for 5 years. They will have 5 visits the first year and 2 the second. Then they will have visits once a year. If participants cancer returns, they will have repeat PET/CT scans.

Conditions

Prostate Cancer

Keywords

PSMA; PET agent; Prostatectomy; Progression Free Survival

Outcome Measures

Primary Outcomes (1)

• progression free survival

  progression-free survival which is improved over that of historical data from a general population

  6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years

Secondary Outcomes (1)

• progression free survival

  6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years

Study Arms (1)

1/18F-DCFPyL PET/CT + radical prostatectomy

EXPERIMENTAL

18F-DCFPyL PET/CT with radical prostatectomy and lymphadenectomy

Drug: 18F-DCFPyL

Interventions

18F-DCFPyL DRUG

18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging

1/18F-DCFPyL PET/CT + radical prostatectomy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA certified laboratory.
• Must have prostate cancer with high risk features defined as:
• Gleason 8 and higher OR
• PSA \> 20 ng/mL OR
• Clinical stage T3a (i.e. likely extraprostatic extension on MRI) or T3b
• Patients must be eligible for and must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT
• Men age greater than or equal to 18 years.
• ECOG performance status \<2
• Patients must have adequate organ and marrow function as defined below:
• Hemoglobin greater than or equal to 9 g/dL
• leukocytes greater than or equal to 3,000/mcL
• platelets greater than or equal to 100,000/mcL
• total bilirubin \<2 X normal institutional limits
• AST(SGOT)/ALT(SGPT) less than or equal to 3 X normal institutional limits
• creatinine \<2 X normal institutional limits

You may not qualify if:

• Any investigational agents in the past 28 days prior to enrollment.
• Clinical stage T4 (tumor invades adjacent structures except seminal vesicles).
• Distant metastatic disease on conventional imaging studies (computed tomography (CT)) of the abdomen and pelvis and bone scan. NaF PET/CT scan cannot substitute for a bone scan. Given lack of specificity of CT for lymph node metastases at lower thresholds, pelvic lymph nodes below 2 cm in the short axis are allowed.
• Any prior hormone therapy used to treat prostate cancer, except limited androgen receptor antagonist therapy, defined as less than or equal to 3 days of treatment. The medication must be discontinued within 5 half-lives of the compound prior to study entry.
• Any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy.
• Contraindication to MRI or PET:
• Patients weighing more than weight limit for the scanner tables or unable to fit within the imaging gantry
• Prior reaction to 18F-DCFPyL
• Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device that are not MRI compatible at 3 T
• Severe claustrophobia unresponsive to oral anxiolytics
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for the protocol procedures or for radical prostatectomy.
• A malignancy within the past 3 years for which prostatectomy is a contraindication.
• Radiotracer administered within 5 half-lives prior to the date of 18F-DCFPyL PET/CT imaging.
• PSMA-targeted imaging within 6 months with 18F-DCFPyL tracer prior to the date of 18F-DCFPyL PET/CT imaging. Participants can have PSMA targeted imaging with Gallium.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Lantheus: collaborator

Study Sites (6)

Tulane University

New Orleans, Louisiana, 70112-2699, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Brigham and Women s Hospital

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107-6541, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page
• https://www.lantheus.com/

MeSH Terms

Conditions

Prostatic Neoplasms

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

Study Officials

• Fatima H Karzai, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: December 4, 2019
• Primary Completion (Estimated): November 19, 2027
• Study Completion (Estimated): November 19, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04-22

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.@@@@@@Requests for all collected IPD data from clinical trials, conducted under a binding collaborative agreement between NCI/DCTD and a pharmaceutical/biotechnology company, that are not under DSMB monitoring must be in compliance with the terms of the binding collaborative agreement and must be approved by NCI/DCTD and the Pharmaceutical Collaborator (i.e., the NCI ETCTN Director in conjunction with the NCI/DCTD Regulatory Affairs Branch).

Locations

US (6)