Clinical trial NCT03113617: 68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer
Official title: 68Ga-RM2 PET/CT for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stage II Prostate Adenocarcinoma
Stage III Prostate Adenocarcinoma
Stage IV Prostate Adenocarcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 44
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity, Specificity, Positive, and Negative Predictive Value of 68Ga-RM2 PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
timeFrame: week 1 study visit following radiopharmaceutical administration, up to 2 hours to assess
Secondary outcomes:
measure: Sensitivity, Specificity, Negative and Positive Predictive Value for Detection of Regional Nodal Metastases in Comparison to Cross Sectional Imaging Performed Contemporaneously With the 68Ga-RM2 PET
timeFrame: week 1 study visit following radiopharmaceutical administration, up to 2 hours to assess
Other outcomes:
measure: Incidence of Osseous and Distant Metastatic Lesions
timeFrame: Up to 3 years
measure: Maximum Standardized Uptake Value (SUVmax) From 68Ga-RM2 PET
timeFrame: Up to 3 years
measure: PSA Progression Free Survival
timeFrame: At 1 year
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford Cancer Institute
name: Andrei Iagaru
role: PRINCIPAL_INVESTIGATOR
References: