prostate cancer prostate cancer
Conditions
Interventions
Patients with a high suspicion of prostate cancer (PCa) based on elevated PSA levels and/or abnormal digital rectal examination(DRE), and a prostate-specific antigen density (PSAD) = 0.20 ng/ml/cm³, b
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Men aged > 18 years old - PSA 3-20 ng/ml - Negative or equivocal MRI (PIRADS 1-3) - PSAD =0.20 ng/ml/cm3, which should be measured with at least two PSA results (for example one of the generalpractitioner and one of the urologist) - Mentally competent and understanding of benefits and potential burden of the study. - Written and signed informed consent. - Willing to undergo study protocol (systemic biopsies plus target biopsies of a lesion visible on PSMA PET/CT)
Exclusion criteria
Exclusion criteria: - PSA > 20 ng/ml - Men who have previously undergone a prostate biopsy - Men who have a prior PCa diagnosis - Using any (anti-)hormonal therapy - Not fulfilling inclusion criteria - Inability to undergo MRI (i.e., claustrophobia, metal implants) - Inability to undergo PSMA PET/CT (i.e., allergic reaction to 68Ga-PSMA or other contrast fluids, claustrophobia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rates of ISUP GG=2 PCa in target biopsies of PSMA PET/CT lesions, which were not detected, by systematic biopsies. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Detection rates of ISUP GG=2 PCa in systematic biopsies in case of negative or equivocal MRI and PSMA PET/CT. - Detection rates of ISUP GG=2 PCa in systematic biopsies and negative or ISUP GG 1 result of PSMA lesion target biopsies. - Level of SUVmax in correlation with with ISUP GG =2 PCa. - Detection of clinically insignificant PCa (ISUP GG 1) in both PSMA-guided target biopsies and in systematic biopsies - Percentage of change in management in case of upgrading based on PSMA-guided biopsies. - Cost-effectiveness of an extra PSMA PET/CT scan. | — |
Countries
Netherlands
Contacts
Public ContactV Sweere
St. Antonius Ziekenhuis
Outcome results
None listed