NCT02559115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Sep 2015

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 18, 2021

Completed
Last Updated

May 18, 2021

Status Verified

June 1, 2020

Enrollment Period

4.7 years

First QC Date

September 22, 2015

Results QC Date

April 27, 2021

Last Update Submit

April 27, 2021

Conditions

Prostate Cancer

Keywords

68Ga-RM2PET/CT scanGastrin Releasing Peptide Receptor (GRPr)14-146

Outcome Measures

Primary Outcomes (1)

  • Localizing Tumors

    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.

    within two weeks prior to the planned prostatectomy

Study Arms (1)

PET/CT imaging with 68Ga-RM2

EXPERIMENTAL

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

Interventions

68Ga-RM2 (RM2)RADIATION
PET/CT imaging with 68Ga-RM2
PET/CT ScanDEVICE
PET/CT imaging with 68Ga-RM2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

BAY 86-7548Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Results Point of Contact

Title
Dr. Hebert A. Vargas Alvarez , MD
Organization
Memorial Sloan Kettering Cancer Center
vargasah@mskcc.org
646-888-5410

Study Officials

  • Herbert Vargas Alvarez, MD, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 24, 2015

Study Start

September 21, 2015

Primary Completion

June 18, 2020

Study Completion

June 18, 2020

Last Updated

May 18, 2021

Results First Posted

May 18, 2021

Record last verified: 2020-06

Locations

US(1)