18F-DCFPyL PET/CT Impact on Treatment Strategies for Patients With Prostate Cancer

NCT04390880 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2019-099757
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this phase II trial study is to determine whether a positron emission tomography (PET)/computed tomography (CT) scan using 18F-DCFPyL affects the clinical management plan in Veterans. In this study, the management plan prior to and after 18F-DCFPyL PET/CT will be recorded by specific questionnaires and corresponding changes in management will be analyzed. The scan will be used to see how the disease has spread. Both the treatment strategies and probable disease outcomes as relevant to clinical endpoints will be assessed. This study is open to Veterans only.

Conditions

Prostate Cancer

Keywords

Prostate cancer; PET/CT

Outcome Measures

Primary Outcomes (1)

• PRIMARY OBJECTIVES: I. To Determine the Impact of 18F-DCFPyL PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer.

  the percentage of patients whose management was changed after PSMA PET/CT

  6 months

Study Arms (1)

PEt/CT arm

EXPERIMENTAL

Subjects receive a PET/CT scan.

Drug: 18F-DCFPyL

Interventions

18F-DCFPyL DRUG

Study participants will receive intravenous administration of 18F-DCFPyL and undergo a PET/CT imaging study. Patients may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.

PEt/CT arm

Eligibility Criteria

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

You may qualify if:

• Participants who fulfill criteria for initial staging or restaging as outlined below:
• Initial treatment strategy decisions (initial staging)
• All participants with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high PSA levels (\>50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies:
• A) Surgery B) External radiation therapy (RT) C) Other focal therapies D) Systemic medical treatment E) Watchful waiting
• Assessment for Subsequent treatment strategy (restaging), any of the following:
• A) Participants with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:
• Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
• Post-radiation therapy : Nadir + greater than or equal to 2 ng/mL rise in PSA B) Participants with known prostate cancer who undergo restaging because of new symptoms C) Participants with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging D) Participants with known prostate cancer who are treated medically or with RLT in whom response to treatment is assessed
• Capability to provide written informed consent
• Able to remain still for duration of each imaging procedure (about 30 minutes) \* Participants may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.

You may not qualify if:

• Less than 18 years-old at the time of radiotracer administration
• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
• Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
• Inability to provide written informed consent

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

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

Results Point of Contact

• Title: Gholam Berenji, M.D.
• Organization: VA Greater Los Angeles Healthcare System

Gholam.Berenji@va.gov

310-268-3547

Study Officials

• Gholam Berenji, M.D.

  Attending Physiscian

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 18, 2020
• Study Start: April 7, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2024-09

Locations

US (1)