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

NCT ID: NCT06706921

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2027-11-01

Brief Summary

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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.

Detailed Description

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The imaging analysis will consist in obtaining quantitative measurements of lesion uptake on the pre- and post-LuPSMA RLT (lesion and whole-body SUVmax, SUVmean and tumor volume) at each time point on all PET/CT scans. PET metrics at the lesion- and whole-body level will be compared among different PET radiopharmaceuticals at the same time point, and changes over time will be assessed.

All patients will be followed-up at our institution and clinical outcome will be correlated to the imaging analysis assessment.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-Fluciclovine PET/CT

Subjects receive 18F-Fluciclovine PET/CT scans.

Group Type EXPERIMENTAL

18F-Fluciclovine PET/CT Scan

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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VA Greater Los Angeles Healthcare System

FED

Sponsor Role lead

Responsible Party

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Gholam Reza Berenji, MD

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gholam Berenji, MD

Role: CONTACT

[email protected]
310-268-3547

Janake Wijesuriya, BS

Role: CONTACT

[email protected]
310-977-5209

Facility Contacts

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Gholam Berenji, MD

Role: primary

[email protected]
310-268-3547

Janake Wijesuriya, BS

Role: backup

[email protected]
310-977-5209

Other Identifiers

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1819674

Identifier Type: -

Identifier Source: org_study_id