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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
NCT03187990 |
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Date of registration:
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13/06/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA
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Scientific title:
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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. |
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Date of first enrolment:
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March 3, 2017 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03187990 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Irene A Burger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UniversitaetsSpital Zuerich |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 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.
2. Patients can have negative prior needle biopsy(ies) for suspected prostate cancer
3. mpMRI with at least one suspicious target lesion (Arm A), or negative mpMRI but
positive biopsy (Arm B).
4. Written informed consent
5. Age > 30
Exclusion Criteria:
1. Age> 80
2. 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)
3. Active urinary tract infection or indwelling catheter
4. Prior pelvic irradiation
5. Prior prostatectomy
6. Prior androgen deprivation hormonal therapy
7. Prostate biopsy within 8 weeks prior to study
8. Prior transurethral resection of the prostate (TURP)
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Drug: [18F]PSMA-1007
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Drug: [68Ga]PSMA-11
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Primary Outcome(s)
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Rate of positive histopathology for [68Ga]PSMA-11 positive lesions
[Time Frame: 7 months]
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Secondary Outcome(s)
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Correlation of [68Ga]PSMA-11 with tumor aggressiveness
[Time Frame: 7 months]
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Secondary ID(s)
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KEK-ZH-NR: 2017-00016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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