18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer

Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET/CT Predicting Clinical Outcome

About This Trial

  • This study is looking at whether an extra, specialized body scan can help doctors predict how well a targeted radiation treatment will work for prostate cancer.
  • It is open only to military Veterans with advanced prostate cancer that has spread and who are already scheduled to receive this specific radiation therapy.
  • Before deciding to take part, patients should know that the study requires having multiple extra imaging scans taken before and throughout their treatment cycles.

More Information

  • 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)-pentanedioi c 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.

Who Can Enroll

  • Age Range: 18 years and older
  • Gender: Male
  • Who This Trial is For: This study is looking at whether an extra, specialized body scan can help doctors predict how well a targeted radiation treatment will work for prostate cancer.

Study Details

  • Start Date: December 15, 2024
  • Lead Sponsor: VA Greater Los Angeles Healthcare System
Full Eligibility Criteria

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.

Treatments

  • Drug: 18F-Fluciclovine PET/CT Scan
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