Detection of Clinically Significant Prostate Cancer With 18F-DCFPyL PET/MR (PSMA-DOCS)
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|ClinicalTrials.gov Identifier: NCT03149861|
Recruitment Status : Active, not recruiting
First Posted : May 11, 2017
Last Update Posted : August 13, 2020
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.
We hypothesize that hybrid PET-MRI, a novel scanner which incorporates MRI with molecular imaging will improve the detection rate of clinically significant tumors.
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.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm, Prostate||Procedure: PET/MR-ultrasound guided Fusion biopsy Procedure: Systemic TRUS guided biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection of Clinically Significant Prostate Cancer With 18F-DCFPyL PET/MR|
|Actual Study Start Date :||June 8, 2017|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: No focal biopsy needed
Patients in which PET/MR have found no focal findings, will undergo a systemic biopsy as per standard of care, without specific cores for study purposes (Systemic TRUS guided biopsy)
Procedure: Systemic TRUS guided biopsy
Transrectal ultrasound guided systemic prostate biopsy
Experimental: Focal biopsy
Patients with a suspicious focal finding on PET/MR, will undergo systemic+focal or focal fusion biopsy (PET/MR-ultrasound guided Fusion biopsy)
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
- Rate of clinically significant prostate cancer (csPCa) detected in the study population by 18F-DCFPyL-PET/mpMR as compared to mpMR alone [ Time Frame: Through study completion, up to 2 years ]We will compare rates of csPCa detection in 18F-DCFPyL-PET, mpMR and fused 18F-DCFPyL-PET/mpMR, with histopathology obtained at targeted fused US-PET/MR biopsy as the standard of reference
- Change in eligibility for focal therapy according to each modality [ Time Frame: Through study completion, up to 2 years ]We will document the proportion of patients who meet eligibility criteria for focal therapy, according to each modality (mpMR, 18F-DCFPyL PET and 18F-DCFPyL PET/MR), as determined in consensus between a radiologist and urologist. The change in proportions of eligible patients, according to each modality, will be reported
- Correlation of tumor grade to PSMA expression on PET (SUV). [ Time Frame: Through study completion, up to 2 years ]Correlation of tumor grade to PSMA expression on PET (SUV).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149861
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|