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RecruitingPhase 2

An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer.

Eclipse: Flotufolastat F 18 to Determine Treatment Success Following Prostate Focal Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 years
  • Procedures mentioned: CT scans, X-rays, PET scans, Injections, Ultrasound, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This phase II trial evaluates how well flotufolastat F 18 positron emission tomography (PET)/computed tomography (CT) imaging works to detect cancer that remains (residual) or that has come back (recurrent) after the completion of focal therapy for prostate cancer."
  • "CT utilizes x-rays that track the body from the outside."
  • "This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan."
  • "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."
  • "After completion of study intervention, patients are followed up at 1 month post-biopsy and then every 12 months for up to 10 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well a flotufolastat F 18 PET/CT scan finds prostate cancer that remains or comes back after treatment. The scan uses a radioactive tracer and x-rays to make pictures inside the body. It is for men who had focal therapy, which treats specific areas of the prostate.

This phase II trial evaluates how well flotufolastat F 18 positron emission tomography (PET)/computed tomography (CT) imaging works to detect cancer that remains (residual) or that has come back (recurrent) after the completion of focal therapy for prostate cancer. Flotufolastat F 18 is a radioactive tracer that binds to prostate specific membrane antigen (PSMA), a protein over-expressed on prostate tumor cells. This allows for visualization of PSMA-expressing cells upon imaging. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, flotufolastat F 18. Because prostate cancer takes up flotufolastat F 18, it can be seen with PET. CT utilizes x-rays that track the body from the outside. CT images provide an exact outline of the organs and potential inflammatory tissue where it occurs in the body. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. Metabolic information means how much of the injected tracer is taken up by inflammatory tissue. Flotufolastat F 18 PET/CT imaging may be an effective and less invasive way to detect residual or recurrent disease in prostate cancer patients, compared to other methods.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men ages 18–90 when joining the study.
  • Have a history of prostate cancer.
  • Had focal therapy 6–36 months before joining. Treatments include laser, freezing (cryotherapy), focused ultrasound (HIFU or Tulsa Pro), electrical pulses (IRE), or radiation placed inside the prostate (brachytherapy).

Who can't join

  • Have a medical reason that makes the flotufolastat F 18 PET/CT scan unsafe.
  • Have a medical reason that makes an ultrasound-guided prostate biopsy unsafe. A biopsy removes small tissue samples for testing.
  • Plan to receive x-ray contrast dye or another PET radioactive tracer less than 24 hours before the scan.
  • Have very low testosterone levels caused by hormone-lowering treatment.
  • Cannot give written consent to join the study.
  • Cannot stay still and lie flat for the scan, which takes about 30 minutes.
  • Received any experimental drugs or substances within 42 days before the first study dose.
  • Cannot understand or follow study instructions or finish the scans or biopsy. Reasons may include severe fear of tight spaces or being unable to keep the arms raised.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Men aged 18-90 at study enrollment * History of prostate cancer * Men who have had focal therapy (laser, cryotherapy, high-intensity focused ultrasound \[HIFU\], Tulsa Pro, irreversible electroporation \[IRE\], brachytherapy) within 6-36 months of enrollment Exclusion Criteria: * Contraindication to flotufolastat F 18 PET CT * Contraindication to ultrasound-guided prostate biopsy * Patients who are planned to have an x-ray contrast agent or other PET radiotracer \< 24 hours prior to the PET scan * Patients with castrate levels of testosterone secondary to androgen deprivation therapy * Inability to provide written informed consent * Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes) * Any investigational agents within 42 days prior to the day of the first dose * Not able to understand and to follow study instructions and requirements. This also includes the inability to complete the study imaging and or biopsy procedures due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time, any condition that precludes raised arms position)

Study sites (1)

CA