Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [18F]PSMA-PET, MRI sequences optimized for prostate cancer examinations.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Drug [18F]PSMA-PET
Pre-surgical imaging using \[18F\]PSMA-PET at Umea University Hospital, 3.5 MBq/kg, i.v. injection. - Device MRI sequences optimized for prostate cancer examinations
T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital
Primary outcome measures
- Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions [Time frame: 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]
Eligibility criteria
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
- cT3, or high suspicion of extra prostatic growth on mpMRI
- Gleason score ≥8
- PSA 20-49 ng/ml
- >18 years
- Given a written consent to participate in the trial
Exclusion criteria
- Non-MR-safe implants or another contraindication to MRI or PET
- 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 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 tumour.
- Creatinine clearance < 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp)
- Tinnitus or severe hearing loss
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Sweden · 2 centers
- Region Skåne — Malmö
- Region Västerbotten — Umeå
Identifiers
NCT: NCT06565247 · PAMP2 · CIV-23-04-042756 · 2022-501892-14-00