BridgeMD
New treatment option for PCA
Official title PSMA PET Combined With MRI for the Detection of PCa
ClinicalTrials.gov ID: NCT07052214
What this study is testing
What is 68Ga-PSMA-11?
68Ga-PSMA-11 is an investigational medicine, being studied as a potential treatment for pca.
Also referred to as Illuccix, Gallium Ga 68 Gozetotide.
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 is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).
- Phase 3: a large, late-stage study
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. Healthy volunteers may be eligible.
You may be able to join if
- Male, at least 18 years old.
- Have a clinical suspicion of csPCa, and indicated for template biopsy after having received an MRI demonstrating PI-RADs 1 to 4 within 6 months of...
- Prostate biopsy naïve.
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines.
- Have the capacity to understand the study and be able and willing to comply with all protocol requirements.
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- Has prior diagnosis of csPCa
- Previous diagnosis of cancer of any primary origin (excluding basal cell carcinoma or squamous cell carcinoma of the skin that has undergone...
See the full eligibility criteria
- Male, at least 18 years old.
- Have a clinical suspicion of csPCa, and indicated for template biopsy after having received an MRI demonstrating PI-RADs 1 to 4 within 6 months of enrollment and/or have non-imaging risk factors (including but not...
- Prostate biopsy naïve.
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines.
- Have the capacity to understand the study and be able and willing to comply with all protocol requirements.
- Provides consent for anatomical template with/without targeted biopsy based on clinical risk, MRI and PSMA PET result.
- Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution to protect their contacts and the general public, especially if a...
- Must agree to practice adequate precautions to prevent pregnancy in a female partner and to avoid potential problems associated with radiation exposure to the unborn child (Recommendations related to contraception and...
- Participants are excluded from the study if any of the following criteria apply:
- Has prior diagnosis of csPCa
- Previous diagnosis of cancer of any primary origin (excluding basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy). 4\. Active prostate infection, or urinary test...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Boca Raton, Florida, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Lafayette, Louisiana, United States
- New Orleans, Louisiana, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Myrtle Beach, South Carolina, United States
- Germantown, Tennessee, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Virginia Beach, Virginia, United States
- Melbourne N., Victoria, Australia
- Sydney, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Boca Raton, Florida, United States; Miami, Florida, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States and 12 more location(s). 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.