18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer

NCT ID: NCT04727736

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-12-31

Brief Summary

This is an interventional, single group assignment, prospective nonrandomized, open label Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.

Detailed Description

This is an trial designed to evaluate the positive predictive value of 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing PSA levels. Patients will receive a single dose of 18FDCFPyL PET and undergo a PET imaging study. 18F-DCFPyL Injection is an 18F-labeled small molecule that targets the extracellular domain of PSMA. One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with ≤ 333 MBq (≤ 9 mCi) of 18F-DCFPyL via this catheter. The dose range for 18F-DCFPyL will be 7 - 9 mCi. The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-DCFPyL + PET imaging

Participants will receive a single dose of 18F-DCFPyL and undergo a PET imaging study.

(The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.)

Group Type: EXPERIMENTAL

18F-DCFPyL

Intervention Type: DRUG

18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand

Interventions

18F-DCFPyL

18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed diagnosis of prostate cancer
• Biochemical recurrence was defined as a PSA of 0.2 or more ng/mL measured more than 6 weeks after prostatectomy or a PSA of 2 or more ng/mL rise above nadir following radiation therapy (ASTRO Phoenix consensus definition)
• Age ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
• Ability to understand and willingness to sign a written informed consent document
• Willing to comply with clinical trial instructions and requirements

Exclusion Criteria

• History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
• Presence of prostate brachytherapy implants unless approved by the PI
• Administration of another radioisotope within five physical half-lives of trial enrollment
• Radiation or chemotherapy within 2 weeks prior to trial enrollment
• Estimated glomerular filtration rate (eGFR) < 15 ml/mmol
• Serum total bilirubin > 3 times the upper limit of normal
• Aspartate transaminase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of normal
• Inadequate venous access
• Claustrophobia or any other condition that would preclude PET imaging
• Patients must not be receiving ADT except per criteria directly below. Patients who received in the past must have a serum testosterone that is recovered to at least 100 ng/dL.
• Patients who have been on ADT +/- novel hormonal agent (NHA) and developed M0 CRPC

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Progenics Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Ashok Muthukrishnan

OTHER

Sponsor Role: lead

Responsible Party

Ashok Muthukrishnan

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ashok Muthukrishnan, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh - Associate Professor

Locations

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HCC 20-009

Identifier Type: -

Identifier Source: org_study_id