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Evaluation of PSMA-PET and mpMRI in high-risk prostate cancer – using histopathologic validation
EU CTIS ID: 2022-501892-14-00
What this study is testing
To evaluate and compare the accuracy of PSMA-PET and mpMRI for identification and delineation of the most clinically relevant intra-prostatic lesions or sub-regions.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed high-risk prostate cancer planned to be treated with radical prostatectomy
- PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer
- ≥4 weeks since last biopsy of the prostate
- One or more of the following criteria: a) cT3, or high suspicion of extra prostatic growth on mpMRI b) Gleason score ≥8 c) PSA 20-49 ng/ml
- >18 years
- Given a written consent to participate in the trial
You likely can't join if
- Non-MR-safe implants or another contraindication to MRI or PET
- Tinnitus or severe hearing loss
- Claustrophobia
- Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain
- WHO PS >1
- Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration such or anti-androgens)
See the full eligibility criteria
- Histologically confirmed high-risk prostate cancer planned to be treated with radical prostatectomy
- PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer
- ≥4 weeks since last biopsy of the prostate
- One or more of the following criteria: a) cT3, or high suspicion of extra prostatic growth on mpMRI b) Gleason score ≥8 c) PSA 20-49 ng/ml
- >18 years
- Given a written consent to participate in the trial
- Non-MR-safe implants or another contraindication to MRI or PET
- Tinnitus or severe hearing loss
- Claustrophobia
- Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain
- WHO PS >1
- Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration such or anti-androgens)
- TUR-P within 6 months
- Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.
- Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumor.
- Creatinine clearance < 30ml/min
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.