Prostate AdenocarcinomaPhase 2NCT07568756
Utilization of Flotufolastat 18F PET for Post-Focal Therapy Prostate Cancer Evaluation
A Phase 2 study testing Flotufolastat F18 PET in people with Prostate Adenocarcinoma and Prostate Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Prostate Cancer
- What is being tested?
- Flotufolastat F18 PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical Center contact
United States1 site
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Michael Daneshvar, MD, 877-827-8839, ucstudy@uci.edu
About this study
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.
- Conditions
- Prostate Adenocarcinoma, Prostate Cancer
- Being tested
- Flotufolastat F18 PET
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flotufolastat F18 PETDiagnostic test
Flotufolastat F18 PET
| Study group | Role | What they receive |
|---|---|---|
| Post-Focal Therapy Flotufolastat F18PET | Experimental | Post-Focal Therapy Flotufolastat F18 PET Receives: Diagnostic Test: Flotufolastat F18 PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flotufolastat F18 PET findings
Compare Flotufolastat F18 PET findings to mpMRI and MRI-fusion biopsy results to determine successful treatment by focal therapy.
Measured: 5 years
Secondary outcomes (3)
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.
Measured: 5 years
Changes in PSA levels
Changes between timepoints in PSA from baseline (pre-therapy) to the defined post-therapy timepoint.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Principal investigator, Michael Daneshvar, University of California, Irvine
- Investigators
- Michael Daneshvar, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568756
- Sponsor's protocol ID
- STUDY00000746
- Other IDs
- UCI 25-100
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Flotufolastat 18F PET for Post-Focal Therapy Prostate Cancer Evaluation
- ClinicalTrials.gov ID
- NCT07568756
- Acronym / sponsor ID
- STUDY00000746
- Conditions
- Prostate Adenocarcinoma, Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- May 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Focal Therapy Flotufolastat F18PET | Experimental | Diagnostic Test: Flotufolastat F18 PETPost-Focal Therapy Flotufolastat F18 PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flotufolastat F18 PETFlotufolastat F18 PET | Diagnostic test | Post-Focal Therapy Flotufolastat F18PET |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical Center contact
Michael Daneshvar, MD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flotufolastat F18 PET in people with Prostate Adenocarcinoma and Prostate Cancer, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flotufolastat F18 PET findings (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.