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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01768 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (68Ga-PSMA-11, PET/CT) | Experimental | Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET/CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Will be summarized by descriptive statistics. | Up to 12 months |
| 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 | Will be summarized by descriptive statistics. | Up to 12 months |
| 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 | Will be summarized by descriptive statistics. | Up to 12 months |
| 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 | Will be summarized by descriptive statistics. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Will be summarized by descriptive statistics. | Up to 12 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography | Will be summarized by descriptive statistics. | Up to 12 months |
| Specificity for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Czernin | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37482512 | Derived | 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. | |
| 34649942 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2023 | |
| Reset | Jul 6, 2023 |
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| Gallium Ga 68 Gozetotide | Radiation | Given IV |
|
|
| Positron Emission Tomography | Procedure | Undergo PET/CT scan |
|
|
Will be summarized by descriptive statistics. |
| Up to 12 months |
| 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 | Will be summarized by descriptive statistics. | Up to 12 months |
| 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 | Will be summarized by descriptive statistics. | Up to 12 months |
Will be summarized by descriptive statistics. |
| Up to 12 months |
| 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 | Will be summarized by descriptive statistics. | Up to 12 months |
| 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 | Will be summarized by descriptive statistics. | Up to 12 months |
| PSA progression free survival | Will compare patients with and without pelvic nodal metastases. | Up to 1 year |
| Standardized uptake value maximum and short axis diameter of nodal disease on cross sectional imaging correlated to presence of true pathology | Up to 12 months |
| Incidence of osseous and distant metastatic lesions | Up to 12 months |
| Impact of 68Ga-PSMA-11 positron emission tomography on clinical management | Up to 12 months |
| Incidence of adverse events | Assessed per Common Terminology Criteria for Adverse Events version 4.03. | Up to 3 days |
| Inter-reader reproducibility | Up to 12 months |
| Sensitivity and specificity on lesions level for 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging | Up to 12 months |
| Quantitative parameters for malignant and benign lesions (BPH, hgPIN, inflammation) in 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging | Up to 12 months |
| Gross-tumor-volume using 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging | Will be compared to tumor extent in histopathology. | Up to 12 months |
| Lesional standardized uptake value maximum from 68Ga-PSMA-11 | Will be correlated with immunohistochemical stainings (e.g. PSMA, PI3K, Akt) and Gleason score. | Up to 12 months |
| Derived |
| 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. |
| 34529005 | Derived | 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. |
| 33602654 | Derived | 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. |
| 32958451 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2023 | Jul 6, 2023 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
| C000622699 | 68Ga-DKFZ-PSMA-11 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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