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

Conditions

Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v7, Stage III Prostate Cancer AJCC v7, Stage IV Prostate Cancer AJCC v7

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.

Loïc Djaileb, Wesley R. Armstrong, Daniel Thompson, Andrei Gafita, Andrea Farolfi et al. (15 authors)

Journal of Clinical Oncology2024-02-01

10.1200/jco.2024.42.4_suppl.285

Presurgical 68Ga-PSMA-11 Positron Emission Tomography for Biochemical Recurrence Risk Assessment: A Follow-up Analysis of a Multicenter Prospective Phase 3 Imaging Trial.

Djaïleb L, Armstrong WR, Thompson D, Gafita A, Farolfi A, Rajagopal A, Grogan TR, Nguyen K, Benz MR, Hotta M, Barbato F, Ceci F, Schwarzenböck 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.

2023-07-2115 citations

10.1016/j.eururo.2023.06.022

Pre-surgical 68Ga-PSMA-11 PET for biochemical recurrence risk assessment: A surrogate of pelvic lymph node dissection? Follow-up analysis of a multicenter prospective phase 3 imaging trial.

Loïc Djaileb, Wesley R. Armstrong, Daniel Thompson, Andrei Gafita, Andrea Farolfi et al. (16 authors)

Journal of Clinical Oncology2023-06-01

10.1200/jco.2023.41.16_suppl.5090

Predictive value of extra-prostatic disease detection by pre-operative PSMA-PET for biochemical recurrence-free survival in patients treated with radical prostatectomy: Follow-up analysis of a multicenter prospective phase 3 imaging trial.

Loïc Djaileb, Wesley R. Armstrong, Daniel Thompson, Kathleen Nguyen, Andrei Gafita et al. (15 authors)

Journal of Clinical Oncology2022-06-011 citations

10.1200/jco.2022.40.16_suppl.5088

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.

Ting Martin Ma, Andrei Gafita, David Shabsovich, Jesus Juarez, Tristan R Grogan et al. (26 authors)

PubMed2022-02-019 citations

10.1016/j.euo.2021.01.006

Head-to-Head Comparison of68Ga-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

Ida Sonni, Ely Felker, Andrew T. Lenis, Anthony Sisk, Shadfar Bahri et al. (16 authors)

Journal of Nuclear Medicine2021-10-14122 citations

10.2967/jnumed.121.262398

Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection

Thomas A. Hope, Matthias Eiber, Wesley R. Armstrong, Roxanna Juarez, Vishnu Murthy et al. (24 authors)

JAMA Oncology2021-09-16321 citations

10.1001/jamaoncol.2021.3771

Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography Compared with Conventional Imaging for Initial Staging of Treatment-naïve Intermediate- and High-risk Prostate Cancer: A Retrospective Single-center Study.

Lenis AT, Pooli A, Lec PM, Sadun TY, Johnson DC, Lebacle C, Fendler WP, Eiber M, Czernin J, Reiter RE, Calais J.

2020-09-1817 citations

10.1016/j.euo.2020.08.012

Accuracy of 68Ga-PSMA-11 for pelvic nodal metastasis detection prior to radical prostatectomy and pelvic lymph node dissection: A multicenter prospective phase III imaging study.

Thomas A. Hope, Wesley R. Armstrong, Vishnu Murthy, Courtney Lawhn-Heath, Spencer C. Behr et al. (20 authors)

Journal of Clinical Oncology2020-05-2022 citations

10.1200/jco.2020.38.15_suppl.5502

LBA02-05 ACCURACY OF 68GA-PSMA-11 FOR PELVIC NODAL METASTASIS DETECTION PRIOR TO RADICAL PROSTATECTOMY AND PELVIC LYMPH NODE DISSECTION: A MULTICENTER PROSPECTIVE PHASE 3 IMAGING STUDY

Thomas M.H. Hope, Wesley R. Armstrong, Vishnu Murthy, Roxanna Juarez, Courtney Lawhn-Heath et al. (23 authors)

The Journal of Urology2020-04-01

10.1097/ju.0000000000000958.05

Total-Body 68Ga-PSMA-11 PET/CT for Bone Metastasis Detection in Prostate Cancer Patients: Potential Impact on Bone Scan Guidelines

Kelsey L. Pomykala, Johannes Czernin, Tristan Grogan, Wesley R. Armstrong, John Williams et al. (6 authors)

Journal of Nuclear Medicine2019-09-2047 citations

10.2967/jnumed.119.230318

PD40-11 THE ROLE OF 68GA-PSMA PET-CT IN INITIAL STAGING OF TREATMENT-NAïVE HIGH RISK PROSTATE CANCER.

Aydin Pooli, Taylor Y. Sadun, David C. Johnson, C. Lebâcle, Wolfgang P. Fendler et al. (9 authors)

The Journal of Urology2019-04-01

10.1097/01.ju.0000556543.86104.2a

Interventions

PROCEDUREComputed Tomography

Undergo PET/CT scan

RADIATIONGallium Ga 68 Gozetotide

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT scan

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Healthy volunteers

No

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 \[HiFu\])

Design outcomes

Primary

Measure	Time frame	Description
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	Up to 12 months	Will be summarized by descriptive statistics.
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	Up to 12 months	Will be summarized by descriptive statistics.
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	Up to 12 months	Will be summarized by descriptive statistics.
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	Up to 12 months	Will be summarized by descriptive statistics.

Secondary

Measure	Time frame	Description
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	Up to 12 months	Will be summarized by descriptive statistics.
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	Up to 12 months	Will be summarized by descriptive statistics.
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	Up to 12 months	Will be summarized by descriptive statistics.
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	Up to 12 months	Will be summarized by descriptive statistics.

Other

Measure	Time frame	Description
Incidence of adverse events	Up to 3 days	Assessed per Common Terminology Criteria for Adverse Events version 4.03.
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	—
Sensitivity for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography	Up to 12 months	Will be summarized by descriptive statistics.
Gross-tumor-volume using 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging	Up to 12 months	Will be compared to tumor extent in histopathology.
Lesional standardized uptake value maximum from 68Ga-PSMA-11	Up to 12 months	Will be correlated with immunohistochemical stainings (e.g. PSMA, PI3K, Akt) and Gleason score.
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	—
Specificity for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography	Up to 12 months	Will be summarized by descriptive statistics.
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	Up to 12 months	Will be summarized by descriptive statistics.
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	Up to 12 months	Will be summarized by descriptive statistics.
PSA progression free survival	Up to 1 year	Will compare patients with and without pelvic nodal metastases.
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	—

Countries

United States

Outcome results

None listed