Flotufolastat F 18 PET/CT for Prostate Cancer

(ECLIPSE Trial)

Overseen By Kyla Grunden

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Investigational agents

Disqualifiers: Castrate testosterone, Informed consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect prostate cancer that may persist or recur after certain treatments. It employs a special imaging technique called flotufolastat F 18 PET/CT, which combines structural images with signals from prostate cancer cells. The aim is to determine if this method can identify cancer more easily and efficiently than traditional methods. Men who have had prostate cancer and received treatments such as laser or cryotherapy in the past 6-36 months may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking investigational agents, you must stop them at least 42 days before the trial starts.

What prior data suggests that this imaging technique is safe for detecting prostate cancer?

Research has shown that flotufolastat F 18, a special dye used in PET/CT scans, is generally safe for patients. Studies have found that it effectively helps doctors identify prostate cancer spots. While primarily used for prostate cancer, it can also appear in other types of cancer, non-cancerous conditions, and normal tissues. Few reports of serious side effects exist, making it a promising tool for detecting disease. However, like any medical procedure, some mild side effects might occur, but they are usually easy to manage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Flotufolastat F 18 is unique because it uses a radioactive tracer specifically designed for PET/CT imaging to detect prostate cancer more accurately. Unlike standard imaging options, which may include MRI or CT scans alone, this treatment involves a PET/CT scan that provides a more detailed view, potentially identifying cancerous cells that other methods might miss. Researchers are excited about this treatment because it could lead to earlier and more precise detection of prostate cancer, allowing for more tailored and effective treatment plans for patients.

What evidence suggests that flotufolastat F 18 PET/CT is effective for detecting residual or recurrent prostate cancer?

Research has shown that flotufolastat F 18 PET/CT, which participants in this trial will undergo, is promising for detecting prostate cancer that persists or returns after treatment. One study found it could reliably identify cancerous areas larger than 5 mm, aiding doctors in treatment decisions. Another study demonstrated that flotufolastat F 18 could detect cancer spread in many patients who had previously undergone surgery or radiation. These findings suggest that flotufolastat F 18 PET/CT could be an effective and less invasive method for identifying remaining or returning prostate cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Wayne Brisbane

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for prostate cancer patients who have finished focal therapy and are being checked for any remaining or returning cancer. It's not specified who can't join, but typically those with health conditions that could interfere with the scan or allergies to the tracer might be excluded.

Inclusion Criteria

I have a history of prostate cancer.

I am a man aged between 18 and 90.

I am a man who has undergone focal therapy for prostate cancer between 6-36 months ago.

Exclusion Criteria

Inability to provide written informed consent

Any investigational agents within 42 days prior to the day of the first dose

I cannot have a prostate biopsy using ultrasound.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive flotufolastat F-18 intravenously and undergo whole-body PET/CT imaging

1 day

1 visit (in-person)

Biopsy

Participants undergo PET/CT/ultrasound fusion biopsy

Within 3 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after biopsy

1 month post-biopsy and then every 12 months for up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Flotufolastat F 18

Trial Overview

The trial is testing a new type of PET/CT scan using Flotufolastat F 18, which highlights prostate cancer cells in imaging. This method may help doctors see if there's any cancer left after treatment without more invasive procedures.

How Is the Trial Designed?

Group I: Diagnostic (flotufolastat F-18 PET/CT) Experimental Treatment 4 Interventions

Patients receive flotufolastat F-18 IV. Then 50-100 minutes after injection, patients undergo whole-body PET/CT over 20-50 minutes. Patients then undergo PET/CT/ultrasound fusion biopsy within 3 months.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

BLUE EARTH DIAGNOSTICS (UNITED KINGDOM)

Collaborator

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12014739/

Prognostic 18F-flotufolastat PET parameters for outcome ...

This retrospective analysis evaluates baseline 18 F-flotufolastat positron emission tomography (PET) parameters as prognostic parameters for treatment response ...

2.

jnm.snmjournals.org

jnm.snmjournals.org/content/66/supplement_1/251457

Real-World Experience on the Diagnostic Efficacy of 18F ...

18 F-flotufolastat PET/CT can be a reliable tool for preoperative N-staging in prostate cancer, especially for detecting lesions >5 mm and can aid in treatment ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.38

Impact of 18F-flotufolastat PET on management of patients ...

Results: Of 389 patients who had 18F-flotufolastat PET, 97 had sufficient MP data for evaluation. These 97 patients were comparable to the ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07185165

An Investigational Scan (Flotufolastat F 18 PET/CT) for ...

Flotufolastat F 18 PET/CT imaging may be an effective and less invasive way to detect residual or recurrent disease in prostate cancer patients ...

5.

advancesradonc.org

advancesradonc.org/article/S2452-1094(24)00095-2/fulltext

Impact of Clinical Factors on 18 F-Flotufolastat Detection ...

By majority read, 18F-flotufolastat identified distant lesions in 39% and 43% of patients treated with prior RP or RT, respectively. The overall ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2023/216023s000lbl.pdf

Page 1 of 12 - accessdata.fda.gov

Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues.

7.

mayoclinic.org

mayoclinic.org/drugs-supplements/flotufolastat-f-18-intravenous-route/description/drg-20551214

Flotufolastat f 18 (intravenous route) - Side effects & uses

Flotufolastat F 18 injection is used with a PET scan (positron emission tomography) of prostate-specific membrane antigen (PSMA) positive lesions in men with ...

8.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.TPS347

Role of 18F-flotufolastat PET/CT imaging in men with high- ...

This is a multicenter, prospective, randomized study comparing 18F-flotufolastat PET/CT to conventional imaging for staging men with high-risk PCa.

9.

jnm.snmjournals.org

jnm.snmjournals.org/content/early/2024/05/23/jnumed.123.267271

True-Positive 18F-Flotufolastat Lesions in Patients with ...

18 F-flotufolastat frequently identified true-positive prostate cancer lesions in patients with negative conventional imaging.