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Evaluating Non-invasive Assessment of Staging with 68Ga-PSMA-PET/CT and 7T-MRI of Primary Prostate Cancer

Evaluating Non-invasive Assessment of Staging with 68Ga-PSMA-PET/CT and 7T-MRI of Primary Prostate Cancer - ENIGMA study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48898
Enrollment
30
Registered
2018-06-27
Start date
2018-10-02
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Prostate malignancy

Interventions

None listed

Sponsors

Urologie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Signed written informed consent - Patients with clinically intermediate to high-risk localized PCa, who are planned for radical prostatectomy (i.e. Gleason score *3+4

Exclusion criteria

Exclusion criteria: - Patients who are unwilling or unable to sign written informed consent - Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the UMC Utrecht (see Appendix I for the 7T-MRI questionnaire). - Patients with previous treatment for PCa. - Patients with a history of radiotherapy to the pelvis. - Patients who underwent a transurethral resection of the prostate (TURP) or stenting of the prostate

Design outcomes

Primary

MeasureTime frame
* To assess the prediction of tumour localisation, extraprostatic extension, metabolism and GS of 7T-MRI for PCa, based on whole-mount histopathology validation after radical prostatectomy. * To assess the prediction of tumour aggressiveness and detection of metastasis, of 68Ga-PSMA-PET/CT for PCa, based on the SUVmax and SUVmean, compared to whole-mount histopathology validation after radical prostatectomy.

Secondary

MeasureTime frame
* To find metabolic markers to predict/mirror PCa Gleason Score, and to create a Gleason score prediction tool for steering individualized treatment options in future studies. * To compare radiological results from 3T-MRI with 7T-MRI for the detection of PCa, GS and EPE. * To assess the ability of 7T-MRI to diagnose extraprostatic extension, by evaluating a threshold value of length of capsular contact of dominant lesions and comparing to whole-mount histopathology validation after radical prostatectomy.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)