68Ga-PSMA-11 PET/CT in Imaging Patients With Intermediate or High Risk Prostate Cancer Before Surgery

Prostate Adenocarcinoma Clinical Trial

Official title:

68Ga-PSMA-11 PET/CT for Staging of Intermediate and High Risk Prostate Cancer Prior to Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03368547
• Other study ID #: 16-001684
• Secondary ID: NCI-2016-01768
• Status: Completed
• Phase: N/A
• Start date: December 12, 2016
• Est. completion date: June 18, 2021

Study information

• Verified date: July 2021
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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])

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostatic Neoplasms
• Stage IIB Prostate Cancer AJCC v7
• Stage III Prostate Cancer AJCC v7
• Stage IV Prostate Cancer AJCC v7

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT scan

Radiation:
• Gallium Ga 68 Gozetotide
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET/CT scan

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Specificity 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
Other	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
Other	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
Other	PSA progression free survival	Will compare patients with and without pelvic nodal metastases.	Up to 1 year
Other	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
Other	Incidence of osseous and distant metastatic lesions		Up to 12 months
Other	Impact of 68Ga-PSMA-11 positron emission tomography on clinical management		Up to 12 months
Other	Incidence of adverse events	Assessed per Common Terminology Criteria for Adverse Events version 4.03.	Up to 3 days
Other	Inter-reader reproducibility		Up to 12 months
Other	Sensitivity and specificity on lesions level for 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging		Up to 12 months
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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	Will be summarized by descriptive statistics.	Up to 12 months
Secondary	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
Secondary	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