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

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Primary Purpose

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Computed Tomography

Gallium Ga 68-labeled GRPR Antagonist BAY86-7548

Laboratory Biomarker Analysis

Positron Emission Tomography

About this trial

This is an interventional diagnostic trial for Stage II Prostate Adenocarcinoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (68Ga-RM2 PET/CT)

Arm 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.

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

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

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

Full Information

NCT ID

NCT03113617

First Posted

April 10, 2017

Last Updated

May 22, 2023

Sponsor

Andrei Iagaru

1. Study Identification

Unique Protocol Identification Number

NCT03113617

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 10, 2017 (Actual)

Primary Completion Date

December 19, 2021 (Actual)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andrei Iagaru

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (68Ga-RM2 PET/CT)

Arm Type

Experimental

Arm 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.

Intervention Type

Procedure

Intervention Name(s)

Computed Tomography

Other Intervention Name(s)

CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

Intervention Description

Undergo PET/CT

Intervention Type

Drug

Intervention Name(s)

Gallium Ga 68-labeled GRPR Antagonist BAY86-7548

Other Intervention Name(s)

(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

Intervention Description

Given IV

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Other Intervention Name(s)

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

Intervention Description

Undergo PET/CT

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Incidence of Osseous and Distant Metastatic Lesions

Time Frame

Up to 3 years

Title

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

Description

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.

Time Frame

Up to 3 years

Title

PSA Progression Free Survival

Description

Patients with and without pelvic nodal metastases will be compared.

Time Frame

At 1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrei Iagaru

Organizational Affiliation

Stanford Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University, School of Medicine

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

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

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial