BridgeMD
Compares treatment options for Prostate Cancer
Official title MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection
ClinicalTrials.gov ID: NCT03819751
What this study is testing
- What it's testing
- With the general acceptance of MRI and technical advances in biopsy technique of the prostate, new questions arise concerning the selection of patients, the approach, the appropriate technique, the lesions to target and the number of biopsies. The purpose of this study is to address these issues in men suspicious of having prostate cancer and without prior biopsies.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75, men only
You may be able to join if
- willing to participate in the study by giving written informed consent.
- male people aged between 50 to 75 years.
- with a clinical suspicion of PCa: elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination (DRE).
- good health condition based on medical history, physical examination and vital sign measurements.
- with target lesion on dedicated MRI of the prostate (PI-RADS 3 to 5).
You likely can't join if
- has a prior history of prostate cancer.
- had prior prostate biopsy.
- has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).
- has evidence of lymph nodes involvement on prostate MRI or abdominal CT
- has evidence of bone metastasis on bone scan.
- has a prior history of hip prosthesis, pelvic radiation therapy or androgen deprivation therapy
See the full eligibility criteria
- willing to participate in the study by giving written informed consent.
- male people aged between 50 to 75 years.
- with a clinical suspicion of PCa: elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination (DRE).
- good health condition based on medical history, physical examination and vital sign measurements.
- with target lesion on dedicated MRI of the prostate (PI-RADS 3 to 5).
- has a prior history of prostate cancer.
- had prior prostate biopsy.
- has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).
- has evidence of lymph nodes involvement on prostate MRI or abdominal CT
- has evidence of bone metastasis on bone scan.
- has a prior history of hip prosthesis, pelvic radiation therapy or androgen deprivation therapy
- unable to perform transrectal ultrasound due to prior rectal surgery or active rectal diseases (rectitis, …)
- has any condition, physical, mental, familial or sociological, that could impede compliance with the study protocol and further follow-up. This is not an absolute contra-indication, but should be discussed with patient...
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Vlaams-brabant, Belgium
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, 50 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaams-brabant, Belgium. 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.