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The goal of this clinical study is to test the performance of PSMA PET/MRI-guided biopsies against systematic biopsies in men with negative MRI scan (PI-RADS 1-2) of the prostate with continuous suspicion of clinically significant prostate cancer (csPCa) due to PSAd > 0.20. The main questions it aims to answer are:
Can biopsies safely be avoided at PRIMARY score 1-2 without missing csPCa? Does targeted PSMA PET/MRI-guided biopsies have a higher detection rate of csPCa compared to systematic biopsies?
Participants will undergo both transperineal MRI/ultrasound fusion target biopsies from PRIMARY score 3-5 lesions on PSMA PET and systematic biopsies irrespective of the PRIMARY-lesion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSMA-guided and systematic biopsies | Experimental | Both PSMA-guided and systematic biopsies are performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA-guided and systematic biopsies | Diagnostic Test | Both PSMA-guided and systematic biopsies are performed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of clinically significant prostate cancer (csPCa) for PSMA guided biopsies vs systematic biopsies | CsPCa is defined as "International Society of Urological Pathology" (ISUP) grade ≥ 2. The ISUP grade scale ranges from 1 to 5, where grade 1 is low-risk / indolent / non-significant prostate cancer and grade 5 is the most aggressive prostate cancer form with worse outcome. | From enrollment to pathology report is ready, assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| High negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2) | A high negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2) means that biopsies can safely be avoided in patients with PRIMARY 1-2 lesions only. | From enrollment to pathology report, assessed up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mads R Jochumsen, MD, Ph.D. | Contact | +45 + 78456270 | madsjoch@rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus N | Aarhus | 8200 | Denmark |
Relevant data from the study will be made avilable and published, but the investigators do not have permission to share individual participant data with external researchers.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Goedstrup Hospital | Recruiting | Herning | Herning | 7400 | Denmark |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |