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

Prostate Cancer Clinical Trial

— PROSPYL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04390880
• Other study ID #: 2019-099757
• Status: Recruiting
• Phase: Phase 2
• Start date: April 7, 2020
• Est. completion date: September 2023

Study information

• Verified date: April 2021
• Source: VA Greater Los Angeles Healthcare System
• Contact: Gholam Berenji, M.D.
• Phone: 310 268-3547
• Email: Gholam.Berenji[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRIMARY OBJECTIVES: I. To determine the impact of 18F-DCFPyL PET/CT on initial and subsequent treatment strategies of patients with prostate cancer.	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