Recruiting

18F-Fluciclovine

Sponsor:

VA Greater Los Angeles Healthcare System

Code:

NCT06706921

Conditions

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Metastatic Prostate Cancer

Male Urogenital Diseases

Prostatic Diseases

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-Fluciclovine PET/CT Scan

Study Details

Brief summary:

This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography/computed tomography 18F-FDG PET/CT and a 18F-DCFPyL PET/CT (18F-DCFPyL (2-(3-{1-carboxy-5-\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography/computed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography/computed tomography ( Axumin PET/CT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET/CT will be acquired within 7 days from the PSMA PET.

This study is open to Veterans only.

Conditions

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Metastatic Prostate Cancer

Male Urogenital Diseases

Prostatic Diseases

Study ID

NCT06706921

Start date

Dec 15, 2024

Status verified date

Sep, 2024

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with mCRPC scheduled to undergo LuPSMA RLT.
  • Willingness to undergo multiple serial PET/CT scans pre- and post-LuPSMA RLT.
  • Ability of providing written informed consent.

Exclusion Criteria:

  • Less than 18 years-old at the time of radiopharmaceutical administration.
  • Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.
  • Contraindications to LuPSMA RLT.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-Fluciclovine PET/CT

Subjects receive 18F-Fluciclovine PET/CT scans.

Interventions

18F-Fluciclovine PET/CT Scan

In this prospective study, an 18F-Fluciclovine PET/CT will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles.18F-Fluciclovine PET/CT will be acquired within 7 days from the PSMA PET.

Primary outcome measure

  • 18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer [ Time Frame: From enrollment to end of treatment at 34 weeks. ]

Central Contacts and Locations

Central contacts

Gholam Berenji, MD

310-268-3547Gholam.Berenji@va.gov

Janake Wijesuriya, BS

310-977-5209Janake.Wijesuriya@va.gov

Locations

VA Greater Los Angeles Healthcare System

Recruiting

Los Angeles, California, United States, 90073

Contacts

Gholam Berenji, MD

310-268-3547gholam.berenji@va.gov

Janake Wijesuriya, BS

310-977-5209Janake.Wijesuriya@va.gov

Principal Investigator:

Gholam Berenji, MD

More Information

Sponsor

VA Greater Los Angeles Healthcare System

Last update posted

Nov 27, 2024

Last verified

Sep, 2024

Keywords

  • Prostate cancer
  • PET/CT
  • Radioligand Therapy
  • Metastatic Castration-Resistant Prostate Cancer
  • PSMA PET

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Greater Los Angeles Healthcare System on 2024-11-27.