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

Jonsson Comprehensive Cancer Center

Status

Completed

Conditions

Stage IV Prostate Cancer AJCC v7

Stage III Prostate Cancer AJCC v7

Prostate Adenocarcinoma

Stage IIB Prostate Cancer AJCC v7

Treatments

Procedure: Positron Emission Tomography

Procedure: Computed Tomography

Radiation: Gallium Ga 68 Gozetotide

Study type

Interventional

Funder types

Other

Identifiers

NCT03368547

NCI-2016-01768 (Registry Identifier)

16-001684

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 patients

Sex

Male

Volunteers

No Healthy Volunteers

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])