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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-23-04-042756 | Other Identifier | Swedish Medical Products Agency | |
| 2022-501892-14-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Umeå University | OTHER |
| Region Skane | OTHER |
| Lund University | OTHER |
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In this trial the connection between image properties (mpMRI and PSMA-PET) and tissue properties (molecular and histopathology) will be investigated in order to improve diagnostics and image-based treatment guidance of prostate cancer.
Open, non-randomized, prospective multi-center trial, with consecutive recruiting, between Skåne University hospital and Umeå University Hospital.
High-risk prostate cancer patients referred for radical prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-surgical imaging of high-risk prostate cancer using [18F]PSMA-PET/mpMRI or mpMRI | Experimental | One-time pre-surgical imaging using [18F]PSMA-PET/mpMRI (at Umea University Hosptial) or mpMRI (at Skåne University Hospital) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]PSMA-PET | Drug | Pre-surgical imaging using [18F]PSMA-PET at Umea University Hospital, 3.5 MBq/kg, i.v. injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions | Spatially defined aggressive PC lesions, or subparts of lesion, identified and defined using PSMA-PET and/or mpMRI compared to histopathology. | Pre-surgical imaging 1-6 weeks before surgery vs. post-surgery histopathology as performed within 1-4 weeks for normal clinical work-up. Within the 5-year time frame of the study, analyses will be complemented with detailed study specific histopathology |
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Inclusion Criteria:
Histologically confirmed 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
>18 years
Given a written consent to participate in the trial
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camilla Thellenberg Karlsson, MD, PhD | Contact | +46907850000 | camilla.thellenberg@umu.se | |
| Tufve Nyholm, PhD | Contact | +46907850000 | tufve.nyholm@umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Camilla Thellenberg Karlsson, MD, PhD | Region Västerbotten | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Skåne | Recruiting | Malmö | Sweden |
Trial data that are possible to de-identify (anonymize) will be made available to other research groups through an open repository such as https://zenodo.org or equivalent. Shared data will not be directly traceable to an individual participant.
Study protocol and anonymized data will be made available after study closure.
Study protocol will be publicly available. Anonymized data will be accessible by request.
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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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| MRI sequences optimized for prostate cancer examinations | Device | T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital |
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| Region Västerbotten | Recruiting | Umeå | Sweden |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |