Clinical trial for Prostate Carcinoma
Official title An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique
ClinicalTrials.gov ID: NCT06865768
What this study is testing
What is Flotufolastat F-18 Gallium?
Flotufolastat F-18 Gallium is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for prostate carcinoma.
Also referred to as (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3.
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
- The study wants to see if this PET‑MRI scan can accurately show tumor tissue and if the areas it highlights match what is found during a standard prostate biopsy.
- Who it's for
- Men who are suspected of having prostate cancer and are scheduled for a biopsy.
- What's involved
- Participants will receive an injection of a tiny amount of radioactive tracer, have a PET‑MRI scan, and then undergo the usual transrectal ultrasound‑MRI fusion biopsy. Additional standard tests may be done as part of the imaging and biopsy process.
- Time commitment
- The study involves a few visits over a few weeks for the scan, the biopsy, and any follow‑up appointments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Male people aged \> 18 years
- Patients with suspected prostate cancer who will have prostate biopsy for confirmation
- Ability to lie still for MRI scanning
- Patients must be able to provide written informed consent
You likely can't join if
- Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections
- Patients with contraindications for MRI including implantable pace makers, cochlear implants
- Patients with uni- or bilateral hip prosthesis
- people with other significant medical conditions that would create unacceptable prostate biopsy risk, compromise retention on study or compromise...
- Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect PET-mpMR result
- Is determined by the Investigator that the patient is clinically unsuitable for the study
See the full eligibility criteria
- Male people aged \> 18 years
- Patients with suspected prostate cancer who will have prostate biopsy for confirmation
- Ability to lie still for MRI scanning
- Patients must be able to provide written informed consent
- Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections
- Patients with contraindications for MRI including implantable pace makers, cochlear implants
- Patients with uni- or bilateral hip prosthesis
- people with other significant medical conditions that would create unacceptable prostate biopsy risk, compromise retention on study or compromise study related assessments
- Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect PET-mpMR result
- Is determined by the Investigator that the patient is clinically unsuitable for the study
- Is incapable of understanding the language in which the information for the patient is given
- Participation in a concurrent clinical trial or in another trial within the past 30 days
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, 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, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.