Utilization of Flotufolastat 18F PET for Post-Focal Therapy Prostate Cancer Evaluation

Phase 2Not Yet RecruitingNCT07568756

University of California, Irvine60 enrolled

Overview

This is a phase II single arm, open-label clinical trial determining diagnostic accuracy of Flotufolastat F18 PET in subjects with prostate adenocarcinoma. These are subjects who have not previously received treatment for prostate cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Adenocarcinoma Prostate Cancer

Interventions

Flotufolastat F18 PETDIAGNOSTIC_TEST

Flotufolastat F18 PET

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or greater at time of consent * Prostate adenocarcinoma (no other histologic subtypes allowed) * Prostate Cancer planned to be treated by focal therapy (e.g. cryotherapy, HIFU, or NanoKnife) * Multiparametric-MRI imaging planned * Planned pre- and post- treatment MRI-fusion biopsy Exclusion Criteria: * Prior treatment for any prostate malignancy (e.g. radiation, focal therapy, or systemic therapy) * Genomic classifiers (e.g. Decipher) signifying intermediate or high-risk disease * PSA \>10 * High-risk prostate cancer (diagnosed by biopsy) * Bilateral prostatic lobe disease

Locations (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

Outcomes

Primary Outcomes

Flotufolastat F18 PET findings

Compare Flotufolastat F18 PET findings to mpMRI and MRI-fusion biopsy results to determine successful treatment by focal therapy.

Time frame: 5 years

Secondary Outcomes

Changes in Circulating Tumor Deoxyribonucleic acid (ctDNA) levels

Changes between timepoints in circulating tumor deoxyribonucleic acid (ctDNA) from baseline (pre-therapy) to the defined post-therapy timepoint.

Time frame: 5 years

Changes in PSA levels

Changes between timepoints in PSA from baseline (pre-therapy) to the defined post-therapy timepoint.

Time frame: 5 years

Change in genomic assay scores

Change in genomic assay scores as measured using each assay's validated soring system from baseline (pre-therapy) to the defined post-therapy timepoint.

Time frame: 5 years

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839 ucstudy@uci.edu

University of California Irvine Medical Center

CONTACT

Data from ClinicalTrials.gov

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