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NCT Number: NCT03113617

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

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.

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Key information

Conditions

Stage II Prostate Adenocarcinoma Stage III Prostate Adenocarcinoma Stage IV Prostate Adenocarcinoma

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Procedure

Undergo PET/CT

Other names: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

Gallium Ga 68-labeled GRPR Antagonist BAY86-7548

Drug

Given IV

Other names: (68)Ga-DOTA-4-amino-1-carboxymethylpiperidine-d-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2, 68Ga-Bombesin Antagonist BAY86-7548, 68Ga-DOTA RM2, 68Ga-DOTA-Bombesin Analog BAY86-7548, [68Ga]-labeled Bombesin Analog BAY86-7548, [68Ga]RM2, BAY 86-7548, Ga-68-labeled Bombesin Antagonist BAY 86-7548, Gallium Ga68-labeled GRPR Antagonist RM2

laboratory biomarker analysis

Other

Correlative studies

Positron Emission Tomography

Procedure

Undergo PET/CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Primary outcomes

  1. Sensitivity, Specificity, Positive, and Negative Predictive Value of 68Ga-RM2 PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy

    Time frame: week 1 study visit following radiopharmaceutical administration, up to 2 hours to assess

    True positive patient is defined as PET positive for regional nodes, pathology at prostatectomy positive for regional nodes or PET positive for regional nodes, pathology negative for regional nodes, imaging after prostatectomy demonstrates node was not removed at surgery, and follow-up biopsy or imaging demonstrates presence of nodal disease. True negative patient is defined as PET negative for regional nodes, pathology at prostatectomy negative for regional nodes. False positive patient is defined as PET positive for regional nodes, pathology at prostatectomy is negative, and imaging after prostatectomy

Secondary outcomes

  1. 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

    Time frame: week 1 study visit following radiopharmaceutical administration, up to 2 hours to assess

    True positive patient is defined as PET positive for regional nodes, pathology at prostatectomy positive for regional nodes or PET positive for regional nodes, pathology negative for regional nodes, imaging after prostatectomy demonstrates node was not removed at surgery, and follow-up biopsy or imaging demonstrates presence of nodal disease. True negative patient is defined as PET negative for regional nodes, pathology at prostatectomy negative for regional nodes. False positive patient is defined as PET positive for regional nodes, pathology at prostatectomy is negative, and imaging after prostatectomy

Other outcomes

  1. Incidence of Osseous and Distant Metastatic Lesions

    Time frame: Up to 3 years

  2. Maximum Standardized Uptake Value (SUVmax) From 68Ga-RM2 PET

    Time frame: Up to 3 years

    Correlation between SUVmax from gallium Ga 68-labeled GRPR antagonist BAY86-7548 PET and short axis diameter of nodal disease on cross sectional imaging correlate to presence of true pathology will be performed.

  3. PSA Progression Free Survival

    Time frame: At 1 year

    Patients with and without pelvic nodal metastases will be compared.

Sponsors and collaborators

Lead sponsor

Andrei Iagaru

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2017
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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