Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Detection of Clinically Significant Prostate Cancer With 18F-DCFPyL PET/MR (PSMA-DOCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03149861
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Neoplasm, Prostate Procedure: PET/MR-ultrasound guided Fusion biopsy Procedure: Systemic TRUS guided biopsy Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection of Clinically Significant Prostate Cancer With 18F-DCFPyL PET/MR
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate cancer study
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients accrued will fit any of the following criteria:

    1. Clinical suspicion of PCa with negative TRUS-guided biopsy or clinically discordant low-risk PCa (suspicion of more extensive/aggressive disease).
    2. Potential candidates for FT (as per institutional guidelines).

Exclusion Criteria:

Patients will be ineligible to participate in this study if they meet any of the following criteria:

  1. Contraindication for MR as per current institutional guidelines.
  2. Contraindication for Gadolinium injection as per current institutional guidelines.
  3. Inability to lie supine for at least 60 minutes.
  4. Prostate biopsy <8 weeks prior to planned PET-MR.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Ur Metser, MD, FRCPC    416-946 4501 ext 3229    ur.metser@uhn.ca   
Principal Investigator: Ur Metser, MD         
Principal Investigator: Catherine O'Brien, MD         
Sub-Investigator: Rebecca Wong, MD         
Sub-Investigator: Erin Kennedy, MD         
Sub-Investigator: Kartik Jhaveri, MD         
Sub-Investigator: Neesha Dhani, MD         
Sub-Investigator: Marianne Koritzinsky, PhD         
Sub-Investigator: Eva Szentgyorgyi, MD         
Sub-Investigator: Douglas Hussey, Bsc         
Sponsors and Collaborators
University Health Network, Toronto

Layout table for additonal information
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03149861     History of Changes
Other Study ID Numbers: CAPCR ID:17-5295
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases