Clinical trial NCT03368547: 68Ga-PSMA-11 PET/CT in Imaging Patients With Intermediate or High Risk Prostate Cancer Before Surgery
Official title: 68Ga-PSMA-11 PET/CT for Staging of Intermediate and High Risk Prostate Cancer Prior to Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Adenocarcinoma
Stage IIB Prostate Cancer AJCC v7
Stage III Prostate Cancer AJCC v7
Stage IV Prostate Cancer AJCC v7
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 400
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 \[HiFu\])

Primary outcomes:
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
timeFrame: Up to 12 months
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
timeFrame: Up to 12 months
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
timeFrame: Up to 12 months
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
timeFrame: Up to 12 months
Secondary outcomes:
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
timeFrame: Up to 12 months
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
timeFrame: Up to 12 months
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
timeFrame: Up to 12 months
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
timeFrame: Up to 12 months
Other outcomes:
measure: Sensitivity for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography
timeFrame: Up to 12 months
measure: Specificity for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography
timeFrame: Up to 12 months
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
timeFrame: Up to 12 months
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
timeFrame: Up to 12 months
measure: PSA progression free survival
timeFrame: 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
timeFrame: Up to 12 months
measure: Incidence of osseous and distant metastatic lesions
timeFrame: Up to 12 months
measure: Impact of 68Ga-PSMA-11 positron emission tomography on clinical management
timeFrame: Up to 12 months
measure: Incidence of adverse events
timeFrame: Up to 3 days
measure: Inter-reader reproducibility
timeFrame: Up to 12 months
measure: Sensitivity and specificity on lesions level for 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging
timeFrame: 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
timeFrame: Up to 12 months
measure: Gross-tumor-volume using 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging
timeFrame: Up to 12 months
measure: Lesional standardized uptake value maximum from 68Ga-PSMA-11
timeFrame: Up to 12 months
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Johannes Czernin
role: PRINCIPAL_INVESTIGATOR
References:
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.
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