Flotufolastat F18 PET for Prostate Cancer

CF
Uo
Overseen ByUniversity of California Irvine Medical Center
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: University of California, Irvine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new imaging technique, Flotufolastat F18 PET, in diagnosing prostate cancer in men who have not yet received treatment. The primary goal is to determine if this method can accurately identify cancer in the prostate. Men diagnosed with prostate adenocarcinoma, a common type of prostate cancer, and planning to undergo focal therapy, such as cryotherapy, may be suitable candidates for this trial. Participants should not have received any previous prostate cancer treatments. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant advancements in prostate cancer diagnosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Flotufolastat F18 PET is safe for diagnosing prostate cancer?

Research has shown that Flotufolastat F18 PET is generally safe for patients. The FDA has approved this imaging agent to detect certain cancer markers in men with prostate cancer, indicating its safety for similar uses.

Additional studies support its safety. Early research found that Flotufolastat F18 is absorbed well by tumors and reduces radioactivity in urine, which helps lower potential side effects. So far, no major side effects directly related to its use have been widely reported. This suggests it is a safe option for those considering joining the trial.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about Flotufolastat F18 PET for prostate cancer because it offers a unique approach to detecting cancerous cells. Unlike traditional imaging methods like bone scans or MRIs, which can sometimes miss small or subtle cancerous areas, Flotufolastat F18 PET uses a radioactive tracer specifically designed to bind to prostate cancer cells. This targeted mechanism allows for more precise imaging, potentially leading to more accurate diagnoses and better-informed treatment decisions. Such precision could improve patient outcomes by ensuring that the cancer is caught and treated effectively at an earlier stage.

What evidence suggests that Flotufolastat F18 PET is effective for diagnosing prostate cancer?

Research has shown that Flotufolastat F18 PET is very effective in diagnosing prostate cancer. Studies have proven its high accuracy, even when other imaging methods fall short. For newly diagnosed patients at high risk, this imaging technique provides clear pictures that assist doctors in determining the best treatment. Additionally, Flotufolastat F18 PET scans have led to changes in treatment plans for many prostate cancer cases, whether new or recurring. This makes it a valuable tool in selecting the right treatment for prostate cancer. Overall, evidence indicates that this imaging method is both effective and safe for diagnosing prostate cancer.12346

Who Is on the Research Team?

MD

Michael Daneshvar, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for men aged 18 or older with prostate adenocarcinoma who have not yet received treatment. They must be planning to get focal therapy (like cryotherapy, HIFU, or NanoKnife) and scheduled for specific MRI scans and biopsies.

Inclusion Criteria

I have prostate adenocarcinoma only.
My prostate cancer will be treated with focal therapy like cryotherapy or HIFU.
* Multiparametric-MRI imaging planned
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Flotufolastat F18 PET imaging to evaluate prostate cancer post-focal therapy

5 years

Follow-up

Participants are monitored for changes in ctDNA, PSA levels, and genomic assay scores

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Flotufolastat F18 PET

Trial Overview

The study is testing how well a special PET scan using Flotufolastat F18 can detect prostate cancer after focal therapy. All participants receive this imaging as part of the single-arm phase II trial.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Post-Focal Therapy Flotufolastat F18PETExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

Blue Earth Diagnostics

Industry Sponsor

Trials
43
Recruited
3,100+

Citations

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

PSA response was achieved in 36.1% (65/180) patients. Median OS was 14.4 months (95% CI, 12.9–15.9 months) and median PSA-PFS was 4.1 months (95 ...

Diagnostic performance of 18 F-flotufolastat PET/CT ...

This post-hoc descriptive analysis aimed to compare the diagnostic performance of 18F-flotufolastat with baseline conventional imaging (CT or ...

Additional Results of POSLUMA (Flotufolastat F 18) ...

This sub-group examined the performance of flotufolastat F 18 PET in newly diagnosed, high-risk prostate cancer patients who had negative results with ...

Real-world data show impact of piflufolastat F18 on ...

Key Takeaways · Piflufolastat F18 scans led to treatment changes in 45% of newly diagnosed and 74% of recurrent prostate cancer cases.

Prostate Imaging—PET: 18 F-Flotufolastat (Posluma)

Diagnostic performance and safety of 18F-rhPSMA-7.3 PET in men with suspected prostate cancer recurrence: results from a phase 3, prospective, ...

PET Scan Study to Detect Prostate Cancer in Patients with ...

Flotufolastat PET scan is FDA Approved for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate ...