Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
[68Ga]PSMA-11
[18F]PSMA-1007
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring PSMA PET/MRI, Guided Biopsy, Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Previously undiagnosed patients with elevated PSA (ages 30-50 PSA >2.5 ng/mL; ages 50-80 PSA > 4ng/mL), eligible for prostate needle biopsy.
- Patients can have negative prior needle biopsy(ies) for suspected prostate cancer
- mpMRI with at least one suspicious target lesion (Arm A), or negative mpMRI but positive biopsy (Arm B).
- Written informed consent
- Age > 30
Exclusion Criteria:
- Age> 80
- Contraindication to MRI or prostate biopsy (e.g. extreme claustrophobia, metallic implants incompatible with MRI, anatomical contraindications, coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies)
- Active urinary tract infection or indwelling catheter
- Prior pelvic irradiation
- Prior prostatectomy
- Prior androgen deprivation hormonal therapy
- Prostate biopsy within 8 weeks prior to study
- Prior transurethral resection of the prostate (TURP)
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PET/MRI before biopsy
PET/MRI after biopsy
Arm Description
Patients with suspected areas on mpMRI will undergo additional [68Ga]PSMA-11 PET/MRI scan with subsequent mpMRI and PET/MRI guided biopsy.
Patients with unclear areas or a negative finding in the mpMRI for MRI guided biopsy but positive biopsy, which will undergo the additional [68Ga]PSMA-11 PET/MRI scan with [68Ga]PSMA.
Outcomes
Primary Outcome Measures
Rate of positive histopathology for [68Ga]PSMA-11 positive lesions
PCA detection of PET/MRI versus mpMRI based on histopathology per patient and per prostate section.
Secondary Outcome Measures
Correlation of [68Ga]PSMA-11 with tumor aggressiveness
Correlation of stanadized uptake value (SUV) on [68Ga]PSMA-11 with Gleason Score on histopathology.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03187990
Brief Title
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA
Official Title
Single-center Study for Biopsy Guidance Using Gallium-68 Labeled Prostate-specific Membrane Antigen (PSMA) PET/MRI in Patients With Elevated PSA Eligible for Prostate Biopsy in Comparison to Multiparametric MRI.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
August 3, 2021 (Actual)
Study Completion Date
August 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Irene Burger
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In 22% of patients with elevated Prostate-specific antigen (PSA) MRI guided biopsy will not detect significant prostate cancer (PCA) (defined as either: Gleason score (GS) ≥ 3+4 or tertiary pattern 5, or final stage ≥ pT3a and/or pN1). Therefore this study evaluates the ability of [68Ga]PSMA PET/MRI to detect and localize significant primary PCA to accurately direct prostate needle biopsy using the Gleason score from the histology of the core biopsies as standard of truth.
Detailed Description
In this open label, single center, non-randomized, diagnostic study we plan to include 40 men with elevated PSA (ages 30-50 PSA >2.5 ng/mL; ages 50-80 PSA > 4ng/mL), which are assigned to a MRI guided biopsy.
These patients will undergo one additional PET/MRI scan with [68Ga]PSMA within two to three weeks before the biopsy (Arm A), or in case of an unclear/negative MRI scan but positive biopsy two to three weeks after biopsy (Arm B). In Arm A a radiologist will delineate the suspected areas on (A) multiparametric magnetic resonance image (mpMRI) and a nuclear medicine physician will delineate and color code the suspicious areas on the PET/MRI: (B) [68Ga]PSMA. The images will be loaded into the BiopSee® system. Lesions positive on both modalities will be labeled as "AB". Every suspicious lesion will be targeted with 3 cores. A maximum of 3 targets will be selected per patient.
For arm B: PET/MRI results will be correlated with the template biopsy results.
The data analysis of Arm A and Arm B will be identical. For the analysis the Gleason score from the histology of the core biopsies will serve as standard of truth.
After completion of the PET/MR study part - an amendment for PET/CT was submitted to the local ethics commity and acknowledged to include 10 more participants with PSMA PET/CT to investigate the use of PET/CT guided biopsy and intraoperative verivication of the target with a gamma counter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
PSMA PET/MRI, Guided Biopsy, Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In both arms PET/MR is compared to mpMRI for diagnostic accuracy for PCA detection.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET/MRI before biopsy
Arm Type
Experimental
Arm Description
Patients with suspected areas on mpMRI will undergo additional [68Ga]PSMA-11 PET/MRI scan with subsequent mpMRI and PET/MRI guided biopsy.
Arm Title
PET/MRI after biopsy
Arm Type
Experimental
Arm Description
Patients with unclear areas or a negative finding in the mpMRI for MRI guided biopsy but positive biopsy, which will undergo the additional [68Ga]PSMA-11 PET/MRI scan with [68Ga]PSMA.
Intervention Type
Drug
Intervention Name(s)
[68Ga]PSMA-11
Other Intervention Name(s)
PSMA PET/MRI
Intervention Description
PET/MRI with [68Ga]PSMA will be compared to mpMRI for biopsy guidance.
Intervention Type
Drug
Intervention Name(s)
[18F]PSMA-1007
Other Intervention Name(s)
PSMA PET/CT
Intervention Description
18F-PSMA-1007 PET/CT for biopsy guidance and intraoperative target verification.
Primary Outcome Measure Information:
Title
Rate of positive histopathology for [68Ga]PSMA-11 positive lesions
Description
PCA detection of PET/MRI versus mpMRI based on histopathology per patient and per prostate section.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Correlation of [68Ga]PSMA-11 with tumor aggressiveness
Description
Correlation of stanadized uptake value (SUV) on [68Ga]PSMA-11 with Gleason Score on histopathology.
Time Frame
7 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Previously undiagnosed patients with elevated PSA (ages 30-50 PSA >2.5 ng/mL; ages 50-80 PSA > 4ng/mL), eligible for prostate needle biopsy.
Patients can have negative prior needle biopsy(ies) for suspected prostate cancer
mpMRI with at least one suspicious target lesion (Arm A), or negative mpMRI but positive biopsy (Arm B).
Written informed consent
Age > 30
Exclusion Criteria:
Age> 80
Contraindication to MRI or prostate biopsy (e.g. extreme claustrophobia, metallic implants incompatible with MRI, anatomical contraindications, coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies)
Active urinary tract infection or indwelling catheter
Prior pelvic irradiation
Prior prostatectomy
Prior androgen deprivation hormonal therapy
Prostate biopsy within 8 weeks prior to study
Prior transurethral resection of the prostate (TURP)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene A Burger, MD
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34725726
Citation
Ferraro DA, Laudicella R, Zeimpekis K, Mebert I, Muller J, Maurer A, Grunig H, Donati O, Sapienza MT, Rueschoff JH, Rupp N, Eberli D, Burger IA. Hot needles can confirm accurate lesion sampling intraoperatively using [18F]PSMA-1007 PET/CT-guided biopsy in patients with suspected prostate cancer. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1721-1730. doi: 10.1007/s00259-021-05599-3. Epub 2021 Nov 2.
Results Reference
derived
PubMed Identifier
33620559
Citation
Ferraro DA, Becker AS, Kranzbuhler B, Mebert I, Baltensperger A, Zeimpekis KG, Grunig H, Messerli M, Rupp NJ, Rueschoff JH, Mortezavi A, Donati OF, Sapienza MT, Eberli D, Burger IA. Diagnostic performance of 68Ga-PSMA-11 PET/MRI-guided biopsy in patients with suspected prostate cancer: a prospective single-center study. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3315-3324. doi: 10.1007/s00259-021-05261-y. Epub 2021 Feb 23.
Results Reference
derived
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Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA
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