68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer

Andrei Iagaru

Status and phase: Completed; Phase 2

Conditions: Stage III Prostate Adenocarcinoma; Stage IV Prostate Adenocarcinoma; Stage II Prostate Adenocarcinoma

Treatments: Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Laboratory Biomarker Analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03113617

NCI-2017-00547 (Registry Identifier)

IRB-40373 (Other Identifier)

PROS0077 (Other Identifier)

Details and patient eligibility

About

This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed tomography (CT) works in detecting regional nodal and distant metastases in patients with intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller tumors than the standard of care CT or magnetic resonance imaging scan.

Full description

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-RM2 PET/CT for detection of intermediate and high-risk prostate cancer prior to prostatectomy.

OUTLINE:

Patients receive 68Ga-RM2 intravenously (IV). Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician.

After completion of study, patients are followed up at 24-48 hours and within 3-12 months.

Enrollment: 44 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy proven prostate adenocarcinoma
• Planned prostatectomy with lymph node dissection
• Intermediate to high-risk disease (as determined by elevated PSA [PSA > 10], 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)
• Diagnostic CT or magnetic resonance imaging (MRI) performed within 30 days prior to the 68Ga-RM2 PET

Exclusion criteria

• Inability to lie still for the entire imaging time (approximately 30 minutes)
• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
• Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

44 participants in 1 patient group

Diagnostic (68Ga-RM2 PET/CT)

Experimental group

Description:

Patients receive 68Ga-RM2 IV. Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician.

Treatment:

Procedure: Positron Emission Tomography

Procedure: Computed Tomography

Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548

Other: Laboratory Biomarker Analysis