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

Not Recruiting

Trial ID: NCT02678351

Age - 18 Years-N/A Condition - Prostate Cancer, Prostate - Localized Gender - Male Accepting Healthy Volunteers - No

Purpose

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.

Official Title

68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer

Stanford Investigator(s)

Andrei Iagaru
Andrei Iagaru

Professor of Radiology (Nuclear Medicine)

Eligibility


INCLUSION CRITERIA

   - Biopsy-proven prostate adenocarcinoma

   - Planned prostatectomy with lymph node dissection

   - 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)

   - Karnofsky performance status of ≥ 50 [or Eastern Cooperative Oncology Group
   (ECOG)/World Health Organization (WHO) equivalent]

   - Diagnostic CT or MRI performed within 90 days of the research PET

   - Able to provide written consent

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 (HiFu)

   - Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and
   surgery

   - Metallic implants (contraindicated for MRI)

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Intervention(s):

drug: 68Ga-PSMA-11

procedure: Magnetic resonance imaging (MRI)

procedure: Positron Emission Tomography (PET)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pranav Hegde
650-721-4080

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