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| Name | Class |
|---|---|
| National Science and Technology Council | FED |
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The goal of this observational study is to learn if Ga-68 PSMA PET/MRI can better diagnose prostate cancer than mpMRI in males between 40 to 85 years old who is naive to prostate biopsy and is suspicious for prostate cancer by elevated PSA or lower urinary tract symptoms. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga-68 PSMA PET/MRI | Diagnostic Test | The participant will undergo a Ga-68 PSMA PET/MRI scan, and then be followed up for 2 years to see if prostate cancer is diagnosed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PPV of concordant PET/MRI lesion plus PI-RADS score 4~5 | Comparing positive predictive values (PPV) of using concordant PET/MRI lesion plus PI-RADS score 4~5 as positive test with PPV of using PI-RADS 4~5 alone as positive test to predict diagnosing prostate cancer within 2 years. | 2 years after PSMA PET/MRI scan |
| NPV of using negative PET lesion plus PI-RADS score 1~3 | Comparing negative predictive values (NPV) of using negative PET lesion plus PI-RADS score 1~3 as negative test with NPV of using PI-RADS 1~3 alone as negative test to predict diagnosing prostate cancer within 2 years. | 2 years after PSMA PET/MRI scan |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who indicated MRI of pelvis due to clinical suspicion of prostate cancer based on elevated PSA (4~20 ng/mL), abnormal digital rectal examination or lower urinary tract syndromes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing-Ren Tseng, MD | Contact | +886-975361314 | drTsengJR@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing-Ren Tseng, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital ,Linkou | Recruiting | Taoyuan City | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26795686 | Background | Eiber M, Weirich G, Holzapfel K, Souvatzoglou M, Haller B, Rauscher I, Beer AJ, Wester HJ, Gschwend J, Schwaiger M, Maurer T. Simultaneous 68Ga-PSMA HBED-CC PET/MRI Improves the Localization of Primary Prostate Cancer. Eur Urol. 2016 Nov;70(5):829-836. doi: 10.1016/j.eururo.2015.12.053. Epub 2016 Jan 18. | |
| 29393268 | Background |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Al-Bayati M, Grueneisen J, Lutje S, Sawicki LM, Suntharalingam S, Tschirdewahn S, Forsting M, Rubben H, Herrmann K, Umutlu L, Wetter A. Integrated 68Gallium Labelled Prostate-Specific Membrane Antigen-11 Positron Emission Tomography/Magnetic Resonance Imaging Enhances Discriminatory Power of Multi-Parametric Prostate Magnetic Resonance Imaging. Urol Int. 2018;100(2):164-171. doi: 10.1159/000484695. Epub 2018 Jan 25. |
| 31502937 | Background | Muehlematter UJ, Burger IA, Becker AS, Schawkat K, Hotker AM, Reiner CS, Muller J, Rupp NJ, Ruschoff JH, Eberli D, Donati OF. Diagnostic Accuracy of Multiparametric MRI versus 68Ga-PSMA-11 PET/MRI for Extracapsular Extension and Seminal Vesicle Invasion in Patients with Prostate Cancer. Radiology. 2019 Nov;293(2):350-358. doi: 10.1148/radiol.2019190687. Epub 2019 Sep 10. |
| 34465492 | Background | Emmett L, Buteau J, Papa N, Moon D, Thompson J, Roberts MJ, Rasiah K, Pattison DA, Yaxley J, Thomas P, Hutton AC, Agrawal S, Amin A, Blazevski A, Chalasani V, Ho B, Nguyen A, Liu V, Lee J, Sheehan-Dare G, Kooner R, Coughlin G, Chan L, Cusick T, Namdarian B, Kapoor J, Alghazo O, Woo HH, Lawrentschuk N, Murphy D, Hofman MS, Stricker P. The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study. Eur Urol. 2021 Dec;80(6):682-689. doi: 10.1016/j.eururo.2021.08.002. Epub 2021 Aug 28. |
| 28608163 | Background | Bates A, Miles K. Prostate-specific membrane antigen PET/MRI validation of MR textural analysis for detection of transition zone prostate cancer. Eur Radiol. 2017 Dec;27(12):5290-5298. doi: 10.1007/s00330-017-4877-x. Epub 2017 Jun 12. |
| 37647549 | Background | Tang W, Tang Y, Qi L, Zhang Y, Tang G, Gao X, Hu S, Cai Y. Benign Prostatic Hyperplasia-Related False-Positive of Prostate-Specific Membrane Antigen-Positron Emission Tomography in the Diagnosis of Prostate Cancer: The Achilles' Heel of Biopsy-Free Radical Prostatectomy? J Urol. 2023 Dec;210(6):845-855. doi: 10.1097/JU.0000000000003680. Epub 2023 Aug 30. |
| 36602577 | Background | Wong LM, Koschel S, Whish-Wilson T, Farag M, Bolton D, Zargar H, Corcoran N, Lawrentschuk N, Christov A, Thomas L, Perry E, Heinze S, Taubman K, Sutherland T. Investigating PSMA-PET/CT to resolve prostate MRI PIRADS4-5 and negative biopsy discordance. World J Urol. 2023 Feb;41(2):463-469. doi: 10.1007/s00345-022-04243-5. Epub 2023 Jan 5. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |