68Ga-PSMA-11 PET/CT in Imaging Patients With Intermediate or High Risk Prostate Cancer Before Surgery
NCT ID: NCT03368547
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2016-12-12
2021-06-18
Brief Summary
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Detailed Description
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I. To assess the sensitivity and specificity of gallium Ga 68 gozetotide (68Ga-PSMA-11) PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis, and on a per patient basis using nodal regional correlation.
SECONDARY OBJECTIVES:
I. To assess the positive and negative predictive value of 68Ga-PSMA-11 PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis, and on a per patient basis using nodal regional correlation.
II. To assess sensitivity, specificity, positive and negative predictive value of 68Ga- PSMA-11 PET for the detection of extra-pelvic nodal metastases, visceral metastases and osseous metastases compared to biopsy and imaging follow-up.
OUTLINE:
Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 20-50 minutes on day 1.
After completion of study, patients are followed up at 2-4 days, then at 12 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (68Ga-PSMA-11, PET/CT)
Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on day 1.
Computed Tomography
Undergo PET/CT scan
Gallium Ga 68 Gozetotide
Given IV
Positron Emission Tomography
Undergo PET/CT scan
Interventions
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Computed Tomography
Undergo PET/CT scan
Gallium Ga 68 Gozetotide
Given IV
Positron Emission Tomography
Undergo PET/CT scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Considered for prostatectomy with lymph node dissection
* Intermediate to high-risk disease (as determined by elevated prostate specific antigen \[PSA\] \[PSA \> 10\], tumor \[T\]-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors)
* Able to provide written consent
* Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent)
Exclusion Criteria
* Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (high-intensity focused ultrasound ablation \[HiFu\])
MALE
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Johannes Czernin
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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References
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Djaileb L, Armstrong WR, Thompson D, Gafita A, Farolfi A, Rajagopal A, Grogan TR, Nguyen K, Benz MR, Hotta M, Barbato F, Ceci F, Schwarzenbock SM, Unterrainer M, Zacho HD, Juarez R, Cooperberg M, Carroll P, Washington S, Reiter RE, Eiber M, Herrmann K, Fendler WP, Czernin J, Hope TA, Calais J. Presurgical 68Ga-PSMA-11 Positron Emission Tomography for Biochemical Recurrence Risk Assessment: A Follow-up Analysis of a Multicenter Prospective Phase 3 Imaging Trial. Eur Urol. 2023 Dec;84(6):588-596. doi: 10.1016/j.eururo.2023.06.022. Epub 2023 Jul 21.
Sonni I, Felker ER, Lenis AT, Sisk AE, Bahri S, Allen-Auerbach M, Armstrong WR, Suvannarerg V, Tubtawee T, Grogan T, Elashoff D, Eiber M, Raman SS, Czernin J, Reiter RE, Calais J. Head-to-Head Comparison of 68Ga-PSMA-11 PET/CT and mpMRI with a Histopathology Gold Standard in the Detection, Intraprostatic Localization, and Determination of Local Extension of Primary Prostate Cancer: Results from a Prospective Single-Center Imaging Trial. J Nucl Med. 2022 Jun;63(6):847-854. doi: 10.2967/jnumed.121.262398. Epub 2021 Oct 14.
Hope TA, Eiber M, Armstrong WR, Juarez R, Murthy V, Lawhn-Heath C, Behr SC, Zhang L, Barbato F, Ceci F, Farolfi A, Schwarzenbock SM, Unterrainer M, Zacho HD, Nguyen HG, Cooperberg MR, Carroll PR, Reiter RE, Holden S, Herrmann K, Zhu S, Fendler WP, Czernin J, Calais J. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial. JAMA Oncol. 2021 Nov 1;7(11):1635-1642. doi: 10.1001/jamaoncol.2021.3771.
Ma TM, Gafita A, Shabsovich D, Juarez J, Grogan TR, Thin P, Armstrong W, Sonni I, Nguyen K, Lok V, Reiter RE, Rettig MB, Steinberg ML, Kupelian PA, Yang DD, Muralidhar V, Chu C, Feng F, Savjani R, Deng J, Parikh NR, Nickols NG, Elashoff D, Czernin J, Calais J, Kishan AU. Identifying the Best Candidates for Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography as the Primary Staging Approach Among Men with High-risk Prostate Cancer and Negative Conventional Imaging. Eur Urol Oncol. 2022 Feb;5(1):100-103. doi: 10.1016/j.euo.2021.01.006. Epub 2021 Feb 16.
Lenis AT, Pooli A, Lec PM, Sadun TY, Johnson DC, Lebacle C, Fendler WP, Eiber M, Czernin J, Reiter RE, Calais J. Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography Compared with Conventional Imaging for Initial Staging of Treatment-naive Intermediate- and High-risk Prostate Cancer: A Retrospective Single-center Study. Eur Urol Oncol. 2022 Oct;5(5):544-552. doi: 10.1016/j.euo.2020.08.012. Epub 2020 Sep 18.
Other Identifiers
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NCI-2016-01768
Identifier Type: REGISTRY
Identifier Source: secondary_id
16-001684
Identifier Type: -
Identifier Source: org_study_id
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