RecruitingPhase 2

Using FAPI PET/MRI to Evaluate Prostate Cancer

Novel FAP-targeted Approach to Imaging Patients With or High-risk for Metastatic Prostate Cancer

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 and older
Sex
All sexes
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

  • Visits mentioned: 2 visits
  • Procedures mentioned: MRI scans

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
  • "Participants will undergo two PET/MRI scans during two research visits, each of which may last up to 2.5 hours."
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 looks at how FAPI, a substance used in scans, attaches to certain cells in prostate cancer tissue. It aims to learn how this may help doctors find and track prostate cancer in adults who have it. Participants will have two PET/MRI scans at two research visits, each lasting up to 2.5 hours.

The goal of this clinical trial is to gain more information about how FAPI (fibroblast activation protein inhibitor) binds to certain type of cells in the tumor tissue. The main question it aims to answer is how this information can be used to better diagnose and track prostate cancer. Participants will undergo two PET/MRI scans during two research visits, each of which may last up to 2.5 hours.

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

Eligibility

Who can join

  • You are age 18 or older.
  • You can and agree to give informed consent, meaning you understand the study and agree to join.
  • You have been diagnosed with prostate cancer.
  • You are scheduled for a routine PSMA PET scan, a scan used for prostate cancer, or had one within the past 4 weeks.
  • You are willing and able to have PET/MRI scans for the study.
  • Optional, not required: You are scheduled for a routine biopsy (tissue sample) of known or suspected cancer spread outside the bones and lymph nodes.

Who can't join

  • You cannot or do not agree to give informed consent.
  • You cannot safely have a PET/MRI scan or are unable to complete it.
  • Having the PET/MRI scan would delay your treatment.
  • You need medicine through a vein to relax and make you sleepy during imaging. Mild anxiety pills are allowed only if you have your own prescription, give consent before taking them, and bring a driver to the research visit.

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

Official eligibility criteria

Inclusion Criteria: * Age 18 years or older * Able and willing to provide informed consent * Known diagnosis of prostate cancer * Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET * Optional: Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases. * Willing and able to undergo PET/MRI as part of this research Exclusion Criteria: * Unable or unwilling to provide informed consent * Contraindication(s) to or inability to undergo PET/MRI * Participants for whom PET/MRI will delay timely delivery of treatment * Participants requiring intravenous (IV) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met: * Have their own prescription for the medication * The informed consent process is conducted prior to the self-administration of this medication * Come to the research visit with a driver

Study sites (1)

WI

  • University of Wisconsin · Madison, WI 53705Ali Pirasteh, MD · Principal investigatorJoshua Lang, PhD · Sub-investigatorDiego Hernando, PhD · Sub-investigatorSteven Cho, MD, PhD · Sub-investigatorMore trials in Madison