TriangleNCT03368547 · CITED IN SOURCE DOCUMENTS
68Ga-PSMA-11 PET/CT in Imaging Patients With Intermediate or High Risk Prostate Cancer Before Surgery
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- NA
- Status at capture
- COMPLETED
- Registry last update
- 2023-04-12
This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with intermediate or high risk prostate cancer before surgery. Diagnostic procedures, such as PET/CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Biopsy proven prostate adenocarcinoma * 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: * Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam * Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (high-intensity focused ultrasound ablation \[HiFu\])
- healthy Volunteers
- false
- sex
- MALE
- std Ages
- CHILD
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on day 1.
- intervention Names
- Procedure: Computed Tomography
- Radiation: Gallium Ga 68 Gozetotide
- Procedure: Positron Emission Tomography
- label
- Diagnostic (68Ga-PSMA-11, PET/CT)
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Diagnostic (68Ga-PSMA-11, PET/CT)
- description
- Undergo PET/CT scan
- name
- Computed Tomography
- other Names
- CAT
- CAT Scan
- Computerized Axial Tomography
- Computerized Tomography
- CT
- CT Scan
- tomography
- type
- PROCEDURE
- arm Group Labels
- Diagnostic (68Ga-PSMA-11, PET/CT)
- description
- Given IV
- name
- Gallium Ga 68 Gozetotide
- other Names
- (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
- (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
- (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
- (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
- (68Ga)Glu-urea-Lys(Ahx)-HBED-CC
- 68Ga-DKFZ-PSMA-11
- 68Ga-HBED-CC-PSMA
- 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
- 68Ga-PSMA
- 68Ga-PSMA-11
- 68Ga-PSMA-HBED-CC
- [68Ga] Prostate-specific Membrane Antigen 11
- type
- RADIATION
- arm Group Labels
- Diagnostic (68Ga-PSMA-11, PET/CT)
- description
- Undergo PET/CT scan
- name
- Positron Emission Tomography
- other Names
- Medical Imaging, Positron Emission Tomography
- PET
- PET Scan
- Positron Emission Tomography Scan
- Positron-Emission Tomography
- proton magnetic resonance spectroscopic imaging
- type
- PROCEDURE
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- DIAGNOSTIC
Enrollment
- count
- 400
- type
- ACTUAL
Registered outcome plans (not posted results)
- other Outcomes
- description
- Will be summarized by descriptive statistics.
- measure
- Sensitivity for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography
- time Frame
- Up to 12 months
- description
- Will be summarized by descriptive statistics.
- measure
- Specificity for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography
- time Frame
- Up to 12 months
- description
- Will be summarized by descriptive statistics.
- measure
- Positive predictive value for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography
- time Frame
- Up to 12 months
- description
- Will be summarized by descriptive statistics.
- measure
- Negative predictive value for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography
- time Frame
- Up to 12 months
- description
- Will compare patients with and without pelvic nodal metastases.
- measure
- PSA progression free survival
- time Frame
- Up to 1 year
- measure
- Standardized uptake value maximum and short axis diameter of nodal disease on cross sectional imaging correlated to presence of true pathology
- time Frame
- Up to 12 months
- measure
- Incidence of osseous and distant metastatic lesions
- time Frame
- Up to 12 months
- measure
- Impact of 68Ga-PSMA-11 positron emission tomography on clinical management
- time Frame
- Up to 12 months
- description
- Assessed per Common Terminology Criteria for Adverse Events version 4.03.
- measure
- Incidence of adverse events
- time Frame
- Up to 3 days
- measure
- Inter-reader reproducibility
- time Frame
- Up to 12 months
- measure
- Sensitivity and specificity on lesions level for 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging
- time Frame
- Up to 12 months
- measure
- Quantitative parameters for malignant and benign lesions (BPH, hgPIN, inflammation) in 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging
- time Frame
- Up to 12 months
- primary Outcomes
- description
- Will be summarized by descriptive statistics.
- measure
- Sensitivity of 68Ga-PSMA-11 positron emission tomography for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis and using nodal regional correlation
- time Frame
- Up to 12 months
- description
- Will be summarized by descriptive statistics.
- measure
- Specificity of 68Ga-PSMA-11 positron emission tomography for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis and using nodal regional correlation
- time Frame
- Up to 12 months
- description
- Will be summarized by descriptive statistics.
- measure
- Positive predictive value of 68Ga-PSMA-11 positron emission tomography for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis and using nodal regional correlation
- time Frame
- Up to 12 months
- description
- Will be summarized by descriptive statistics.
- measure
- Negative predictive value of 68Ga-PSMA-11 positron emission tomography for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis and using nodal regional correlation
- time Frame
- Up to 12 months
- secondary Outcomes
- description
- Will be summarized by descriptive statistics.
- measure
- Sensitivity of 68Ga-PSMA-11 positron emission tomography for the detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases compared to biopsy and imaging follow-up
- time Frame
- Up to 12 months
- description
- Will be summarized by descriptive statistics.
- measure
- Specificity of 68Ga-PSMA-11 positron emission tomography for the detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases compared to biopsy and imaging follow-up
- time Frame
- Up to 12 months
- description
- Will be summarized by descriptive statistics.
- measure
- Positive predictive value of 68Ga-PSMA-11 positron emission tomography for the detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases compared to biopsy and imaging follow-up
- time Frame
- Up to 12 months
- description
- Will be summarized by descriptive statistics.
- measure
- Negative predictive value of 68Ga-PSMA-11 positron emission tomography for the detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases compared to biopsy and imaging follow-up
- time Frame
- Up to 12 months
Full study description
- brief Summary
- This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with intermediate or high risk prostate cancer before surgery. Diagnostic procedures, such as PET/CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread.
- detailed Description
- PRIMARY OBJECTIVE: 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.
Source references
- references
- citation
- 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.
- pmid
- 37482512
- type
- DERIVED
- citation
- 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.
- pmid
- 34649942
- type
- DERIVED
- citation
- 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.
- pmid
- 34529005
- type
- DERIVED
- citation
- 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.
- pmid
- 33602654
- type
- DERIVED
- citation
- 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.
- pmid
- 32958451
- type
- DERIVED
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