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

April 6, 2021 updated by: VA Greater Los Angeles Healthcare System

IMPACT OF 18F-DCFPyL PET/CT ON INITIAL AND SUBSEQUENT TREATMENT STRATEGIES OF PATIENTS WITH PROSTATE CANCER (PROSPYL)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90073
        • Recruiting
        • VA Greater Los Angeles Healthcare System
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gholam Berenji, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Participants who fulfill criteria for initial staging or restaging as outlined below:

    1. 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

    2. 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:

  1. Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP

  2. 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEt/CT arm
Subjects receive a PET/CT scan.
Drug: 18F-DCFPyL
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRIMARY OBJECTIVES: I. To determine the impact of 18F-DCFPyL PET/CT on initial and subsequent treatment strategies of patients with prostate cancer.
Time Frame: 2 years
To determine the impact of 18F-DCFPyL PET/CT on initial and subsequent treatment strategies of patients with prostate cancer. This study uses questionnaires completed by the referring physician. A pre-scan questionnaire , a post-scan questionnaire and a follow-up questionnaire will be used to determine whether 18F-DCFPyL PET/CT affected intended treatment strategies and whether these intended treatment strategies were finally implemented.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Greater Los Angeles Healthcare System

Investigators

  • Principal Investigator: Gholam Berenji, M.D., Attending Physiscian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2020

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-099757

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on 18F-DCFPyL

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe