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Not yet recruiting NCT07568756

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

Phase II Interventional Prostate Adenocarcinoma Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Flotufolastat F18 PET.
Who it may be relevant to
Registry conditions: Prostate Adenocarcinoma, Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Diagnostic test Flotufolastat F18 PET
    Flotufolastat F18 PET

Primary outcome measures

  • Flotufolastat F18 PET findings [Time frame: 5 years]
Secondary outcome measures (3)
  • Changes in Circulating Tumor Deoxyribonucleic acid (ctDNA) levels [Time frame: 5 years]
  • Changes in PSA levels [Time frame: 5 years]
  • Change in genomic assay scores [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange

Identifiers

NCT: NCT07568756 · STUDY00000746 · UCI 25-100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗