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

ConditionsProstate AdenocarcinomaProstate Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, Irvine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Flotufolastat F18 PET

    Diagnostic test

    Flotufolastat F18 PET

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Post-Focal Therapy Flotufolastat F18PETExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

Changes in PSA levels

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

Time frame
5 years
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Blue Earth Diagnostics

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: