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New treatment option for Prostate Carcinoma
Official title An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer.
ClinicalTrials.gov ID: NCT07185165
What this study is testing
What is Fluorine F 18 Flotufolastat?
Fluorine F 18 Flotufolastat is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate carcinoma.
Also referred to as FLOTUFOLASTAT F-18, RHPSMA-7.3C.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90, men only
You may be able to join if
- 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]...
You likely can't join if
- 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)
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.