common.study.topics.clinical

Detection of Clinically Significant Prostate Cancer

common.study.values.description

Detection of Clinically Significant Prostate Cancer With 18F-DCFPyL PET/MR

Background: Currently, patients suspected of having prostate cancer undergo ultrasound-guided systematic biopsies of the prostate. However, up to a quarter of clinically significant tumors, which may pose a risk to patient's well-being, may be missed on random biopsies. MRI enables detection of further tumors in this patient population, but also has limited accuracy. Study hypothesis: We hypothesize that hybrid PET-MRI, a novel scanner which incorporates MRI with molecular imaging will improve the detection rate of clinically significant tumors. Study design: In this prospective trial, we will recruit 57 men who are suspected of having prostate cancer but have had negative systematic biopsies, who have been diagnosed with low-risk disease but have clinically signs of more aggressive tumor or who have a focal tumor detected and are candidates for minimally-invasive tumor ablation (=tumor destruction with laser or ultrasound waves), in whom it is crucial to exclude other tumor sites. All patients will undergo PET/MRI after injection of a radiopharmaceutical called "18F-DCFPyL". This is a radioactive probe which has been shown in preliminary studies to be sensitive and specific for detection of prostate cancer. All lesions detected on PET/MRI will undergo biopsy under ultrasound using fused PET/MRI and ultrasound images for guidance, and compared to histopathology. The primary outcome measure in this study is the proportion of clinically significant prostate cancers that are detected with PET/MRI compared to MRI alone. Improved detection of clinically significant prostate cancer may enable a tailored, personalized therapeutic approach, decreasing morbidity and potentially improving overall patient outcome.

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

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common.study.values.methods

No pharmaceutical medication involved common.study.methods.has-drugs-no
Recruiting patients only common.study.methods.is-healthy-yes

Procedure - PET/MR-ultrasound guided Fusion biopsy

All focal lesion with PI-RADS >=3 on MR or with DCFPyL uptake on PET will undergo a focal fusion biopsy

Procedure - Systemic TRUS guided biopsy

Transrectal ultrasound guided systemic prostate biopsy

participant.views.study.view.additional

participant.views.study.view.scientific-title

Detection of Clinically Significant Prostate Cancer With 18F-DCFPyL PET/MR

common.study.values.clinical-trial-id

NCT03149861

participant.views.study.view.id

Rb4n1e