68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02559115
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arm: 1
• Actual Duration (Months): 56.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to see if a new diagnostic research agent named 68Ga-RM2 can show prostate cancer on a PET/CT scan. 68Ga-RM2 stands for Galium-68 labeled DOTA-4-amino-1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2. This study is being done because there are unmet medical needs to improve the current ways of detecting prostate cancers before surgery.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: 68Ga-RM2 (RM2); Device: PET/CT Scan	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Phase II Study of 68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer
• Actual Study Start Date: Sep 21, 2015
• Actual Primary Completion Date: Jun 18, 2020
• Actual Study Completion Date: Jun 18, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: PET/CT imaging with 68Ga-RM2 The intervention is the administration of a single dose of 150-200 MBq 68Ga-RM2 (mass <= 30 μg) for imaging purposes. This will be followed by a 30-40 min PET/CT study after a waiting period of 60 min (+/- 10 min). Prior clinical experience suggests that imaging can be performed within 1 hour post injection (27, 28). MR imaging and prostatectomy will be performed as standard of care at MSKCC.

Radiation: 68Ga-RM2 (RM2); Device: PET/CT Scan

Outcome Measures

Primary Outcome Measures

1. Localizing Tumors [within two weeks prior to the planned prostatectomy]

   Localization will be defined using a total of 12 regions within the prostate: right and left base, midgland and apex in both peripheral and transition zones. The uptake on each region will be assessed by a radiologist blinded to standard of care imaging and clinical characteristics. Histopathological confirmation will be used as the gold standard.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥18 years

• Biopsy proven adenocarcinoma of the prostate

• Patients with low-risk, intermediate-risk and high-risk tumors according to NCCN guidelines (2.2014) will be included

• Planned radical prostatectomy at MSKCC

• Multiparametric MRI of the pelvis (performed or planned) as routine care

Exclusion Criteria:

• Patients meeting any of the following exclusion criteria will not be eligible for study entry:

• Hematologic

• Platelets <75K/mcL

• ANC <1.0 K/mcL

• Hepatic laboratory values

• Bilirubin >2.0 x ULN (institutional upper limits of normal)

• AST/ALT >2.5 x ULN

• Renal laboratory values

o Creatinine > 2.0 x ULN

• Claustrophobia interfering with MRI and PET/CT imaging

• Prior pelvic radiation

• Prior androgen deprivation therapy

• Patients deemed not surgical candidates due to prohibitive co-morbidities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Herbert Vargas Alvarez, MD, PhD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 5, 2018

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT02559115
• Other Study ID Numbers: 14-146
• First Posted: Sep 24, 2015
• Last Update Posted: May 18, 2021
• Last Verified: Jun 1, 2020

• Keywords provided by Memorial Sloan Kettering Cancer Center: 68Ga-RM2; PET/CT scan; Gastrin Releasing Peptide Receptor (GRPr); 14-146
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	PET/CT Imaging With 68Ga-RM2
Arm/Group Description	The intervention is the administration of a single dose of 150-200 MBq 68Ga-RM2 (mass <= 30 μg) for imaging purposes. This will be followed by a 30-40 min PET/CT study after a waiting period of 60 min (+/- 10 min). Prior clinical experience suggests that imaging can be performed within 1 hour post injection (27, 28). MR imaging and prostatectomy will be performed as standard of care at MSKCC. 68Ga-RM2 (RM2) PET/CT Scan
Period Title: Overall Study
STARTED	19
COMPLETED	16
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	PET/CT Imaging With 68Ga-RM2
Arm/Group Description	The intervention is the administration of a single dose of 150-200 MBq 68Ga-RM2 (mass <= 30 μg) for imaging purposes. This will be followed by a 30-40 min PET/CT study after a waiting period of 60 min (+/- 10 min). Prior clinical experience suggests that imaging can be performed within 1 hour post injection (27, 28). MR imaging and prostatectomy will be performed as standard of care at MSKCC. 68Ga-RM2 (RM2) PET/CT Scan
Overall Participants	19
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	60
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	19 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5.3%
Not Hispanic or Latino	18 94.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 10.5%
White	15 78.9%
More than one race	0 0%
Unknown or Not Reported	2 10.5%
Region of Enrollment (Count of Participants)
United States	19 100%

Outcome Measures

1. Primary Outcome

Title	Localizing Tumors
Description	Localization will be defined using a total of 12 regions within the prostate: right and left base, midgland and apex in both peripheral and transition zones. The uptake on each region will be assessed by a radiologist blinded to standard of care imaging and clinical characteristics. Histopathological confirmation will be used as the gold standard.
Time Frame	within two weeks prior to the planned prostatectomy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PET/CT Imaging With 68Ga-RM2
Arm/Group Description	The intervention is the administration of a single dose of 150-200 MBq 68Ga-RM2 (mass <= 30 μg) for imaging purposes. This will be followed by a 30-40 min PET/CT study after a waiting period of 60 min (+/- 10 min). Prior clinical experience suggests that imaging can be performed within 1 hour post injection (27, 28). MR imaging and prostatectomy will be performed as standard of care at MSKCC. 68Ga-RM2 (RM2) PET/CT Scan
Measure Participants	19
Measure Areas Analyzed	192
Containing cancer	128
Not containing cancer	64

Adverse Events

Time Frame	Up to 1 day following study intervention.
Arm/Group Title	PET/CT Imaging With 68Ga-RM2
Arm/Group Description	The intervention is the administration of a single dose of 150-200 MBq 68Ga-RM2 (mass <= 30 μg) for imaging purposes. This will be followed by a 30-40 min PET/CT study after a waiting period of 60 min (+/- 10 min). Prior clinical experience suggests that imaging can be performed within 1 hour post injection (27, 28). MR imaging and prostatectomy will be performed as standard of care at MSKCC. 68Ga-RM2 (RM2) PET/CT Scan
All Cause Mortality
	PET/CT Imaging With 68Ga-RM2
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Serious Adverse Events
	PET/CT Imaging With 68Ga-RM2
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Other (Not Including Serious) Adverse Events
	PET/CT Imaging With 68Ga-RM2
	Affected / at Risk (%)	# Events
Total	6/19 (31.6%)
Investigations
Lymphocyte count decreased	4/19 (21.1%)
Metabolism and nutrition disorders
Hypocalcemia	1/19 (5.3%)
Hyponatremia	1/19 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.