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NCT Number: NCT07568756

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

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.

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Key information

Conditions

Prostate Adenocarcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

Location contact

Michael Daneshvar, MD

CONTACT

[email protected]

877-827-8839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flotufolastat F18 PET

Diagnostic Test

Flotufolastat F18 PET

Primary outcomes

  1. Flotufolastat F18 PET findings

    Time frame: 5 years

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

Secondary outcomes

  1. Changes in Circulating Tumor Deoxyribonucleic acid (ctDNA) levels

    Time frame: 5 years

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

  2. Changes in PSA levels

    Time frame: 5 years

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

  3. Change in genomic assay scores

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

1-877-827-8839

University of California Irvine Medical Center

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Blue Earth Diagnostics

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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