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

Andrei Iagaru

Status and phase: Completed; Phase 3; Phase 2

Conditions: Stage III Prostate Adenocarcinoma; Stage II Prostate Adenocarcinoma

Treatments: Procedure: Positron Emission Tomography (PET); Procedure: Magnetic resonance imaging (MRI); Drug: 68Ga-PSMA-11

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02678351

IRB-35931 (Other Identifier)

PROS0075 (Other Identifier)

NCI-2016-00092 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

1. To evaluate 68Ga-PSMA-11 PET/MRI for detection of tumor metastases in patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection.
2. To assess sensitivity (positive predictive value) and specificity (negative predictive value) of 68Ga-PSMA-11 PET/MRI for the detection of regional nodal metastases compared to pathology at radical prostatectomy.

OUTLINE:

Participants will receive 68Ga-PSMA-11 intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.

After completion of study, patients are followed up at 24 to 48 hours.

Enrollment: 74 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

68Ga-PSMA PET/MRI

Experimental group

Description:

Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.

Treatment:

Drug: 68Ga-PSMA-11

Procedure: Magnetic resonance imaging (MRI)

Procedure: Positron Emission Tomography (PET)