BridgeMD
New treatment option for Prostate Cancer Screening
Official title PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
ClinicalTrials.gov ID: NCT06923657
What this study is testing
- What it's testing
- The goal is to provide more accurate diagnostic tools and optimized diagnostic workflows for clinically suspected prostate cancer patients with prior negative biopsies, improving early detection rates for csPCa and reducing missed diagnoses.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 85, men only
You may be able to join if
- Serum PSA \> 4 ng/mL
- At least one prior negative prostate biopsy
- At least two consecutive increases in PSA and/or PHI
- Negative digital rectal examination
- Multiparametric MRI (mpMRI) indicating a PI-RADS score ≤ 3
You likely can't join if
- Age ≤ 30 years or \> 85 years
- Concurrent presence of other malignant tumors
- Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy)
- Inability to comply with PSMA PET/MRI examination (e.g., contrast allergy, claustrophobia, etc.)
- Contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.)
- Severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment)
See the full eligibility criteria
- Serum PSA \> 4 ng/mL
- At least one prior negative prostate biopsy
- At least two consecutive increases in PSA and/or PHI
- Negative digital rectal examination
- Multiparametric MRI (mpMRI) indicating a PI-RADS score ≤ 3
- Age ≤ 30 years or \> 85 years
- Concurrent presence of other malignant tumors
- Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy)
- Inability to comply with PSMA PET/MRI examination (e.g., contrast allergy, claustrophobia, etc.)
- Contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.)
- Severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment)
- Incomplete clinical or pathological data
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
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 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, 30 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. 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.