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New treatment option for Prostate Cancer (Diagnosis)
Official title Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging
ClinicalTrials.gov ID: NCT07369570
What this study is testing
- What it's testing
- The goal of this clinical trial is to prospectively investigate the evolution of lesions in biparametric magnetic resonance imaging (bpMRI) of the prostate in men with no clinically significant prostate cancer (csPCa) in their initial biopsy. The main questions it aims to answer are: Does lesion progression in bpMRI predict a diagnosis of csPCa in per-protocol follow-up biopsies?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, men only
You may be able to join if
- Suspicion of a local prostate cancer
- Patient have 1-2 PI-RADS 3-5 lesion/lesions in biparametric prostate MRI, with no ISUP 2-5 prostate cancer in an initial systematic or...
- Prostate biopsies can be taken via transrectal approach in an outpatient clinic
- An estimated life expentancy exceeding 10 years
- The patient is cooperative, fluent in Finnish and understands the significance of the study
You likely can't join if
- The patient had undergone prostate biopsies prior to the biopsies that led to recruitment for the current study.
- The physician's suspicion of a locally advanced or a high risk prostate cancer. Absolute exclusion criteria are PSA \>20 ng/ml or T4 staged prostate...
- Seriuos infectious or non-infectious complication after initial biopsy
- Deep immunosuppression due to organ transplant, hematologic disease, or related causes.
- Any treatment given for prostate cancer diagnosed in initial biopsy
- Hip prosthesis or any other object in the pelvic area that affects high-quality MRI
See the full eligibility criteria
- Suspicion of a local prostate cancer
- Patient have 1-2 PI-RADS 3-5 lesion/lesions in biparametric prostate MRI, with no ISUP 2-5 prostate cancer in an initial systematic or lesion-targeted (at least two biopsy cores per lesion) biopsy
- Prostate biopsies can be taken via transrectal approach in an outpatient clinic
- An estimated life expentancy exceeding 10 years
- The patient is cooperative, fluent in Finnish and understands the significance of the study
- The patient signs an informed consent form approved by the ethics committee.
- The patient had undergone prostate biopsies prior to the biopsies that led to recruitment for the current study.
- The physician's suspicion of a locally advanced or a high risk prostate cancer. Absolute exclusion criteria are PSA \>20 ng/ml or T4 staged prostate finding MRI or clinical examination
- Seriuos infectious or non-infectious complication after initial biopsy
- Deep immunosuppression due to organ transplant, hematologic disease, or related causes.
- Any treatment given for prostate cancer diagnosed in initial biopsy
- Hip prosthesis or any other object in the pelvic area that affects high-quality MRI
- Claustrophobia or other absolute or relative contraindication for high-quality MRI
The study team makes the final eligibility decision.
Where it's taking place
- Kuopio, Finland
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, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kuopio, Finland. 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.