Clinical Trial · NCT02678351

68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery

Overview

This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer, and reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.

Sponsor

Stanford University

Phase

Phase 2/3

Contacts

Andrei Iagaru (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02678351

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Eligibility

Inclusion

Biopsy-proven prostate adenocarcinoma
Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery
Planned prostatectomy with lymph node dissection
Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal ablation techniques (HiFu)
Intermediate- to high-risk disease (as determined by elevated prostate-specific antigen (PSA) \[PSA \> 10\], T stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors)
Diagnostic CT or MRI performed within 90 days of the research PET
Karnofsky performance status of ≥ 50 \[or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent\]

Exclusion

Exclusion criteria not yet provided.