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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04390880
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
VA Greater Los Angeles Healthcare System

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 18F-DCFPyL Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: IMPACT OF 18F-DCFPyL PET/CT ON INITIAL AND SUBSEQUENT TREATMENT STRATEGIES OF PATIENTS WITH PROSTATE CANCER (PROSPYL)
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390880


Contacts
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Contact: Gholam Berenji, M.D. 310 268-3547 Gholam.Berenji@va.gov

Locations
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United States, California
VA Greater Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: Alex Alas    310-478-3711 ext 41399    Alexander.Alas@va.gov   
Contact: Gholam Berenji, M.D.    310 268-3547    Gholam.Berenji@va.gov   
Principal Investigator: Gholam Berenji, M.D.         
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
Investigators
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Principal Investigator: Gholam Berenji, M.D. Attending Physiscian
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Responsible Party: VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT04390880    
Other Study ID Numbers: 2019-099757
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VA Greater Los Angeles Healthcare System:
Prostate cancer
PET/CT
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases