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

Part of paid clinical trials in Los Angeles, California.

Sponsor
VA Greater Los Angeles Healthcare System
Study ID
NCT06706921
Phase
PHASE4
Status
Recruiting
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Conditions

  • Genital Diseases, Male
  • Genital Neoplasms, Male
  • Male Urogenital Diseases
  • Metastatic Prostate Cancer
  • Neoplasms
  • Neoplasms by Site
  • Prostatic Diseases
  • Prostatic Neoplasms
  • Prostatic Neoplasms, Castration-Resistant
  • Urogenital Diseases, Male
  • Urogenital Neoplasms

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 18F-Fluciclovine PET/CT Scan — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 15, 2024
Status verified
Sep 2024
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 18F-Fluciclovine PET/CT
    Subjects receive 18F-Fluciclovine PET/CT scans.

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

Locations (1)

FacilityCityStateZIPSite coordinators
VA Greater Los Angeles Healthcare SystemLos AngelesCalifornia90073
Gholam Berenji, MD
[email protected]
310-268-3547
Janake Wijesuriya, BS
[email protected]
310-977-5209
Gholam Berenji, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
VA Greater Los Angeles Healthcare System· Los Angeles, CA

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