NCT03949517

Brief Summary

This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 prostate-cancer

Timeline
Completed

Started Apr 2019

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

April 9, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2022

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

2.9 years

First QC Date

May 10, 2019

Results QC Date

December 1, 2023

Last Update Submit

January 26, 2024

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained

    Positron emission tomography (PET) based of Assessment of Local Therapeutic Response. Therapeutic response to HIFU will be assessed by 68-Ga PSMA 11 and 68-Ga RM2 PET scans.

    Up to approximately 2 hours to complete each scan

Study Arms (2)

68-Ga RM2+68-Ga PSMA11

EXPERIMENTAL

68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11

Drug: 68-Ga RM2Drug: 68-Ga PSMA11Device: Investigational software and coils in PET/MR ScanProcedure: PET/MRI

68-Ga PSMA11+68-Ga RM2

EXPERIMENTAL

68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11

Drug: 68-Ga RM2Drug: 68-Ga PSMA11Device: Investigational software and coils in PET/MR ScanProcedure: PET/MRI

Interventions

68-Ga RM2DRUG

Radioactive agent

Also known as: 68Ga-DOTA-4-amino-1-carboxymethyl-piperidine-DPhe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2, 68Ga-DOTA-Bombesin, BAY86-7548
68-Ga PSMA11+68-Ga RM268-Ga RM2+68-Ga PSMA11
68-Ga PSMA11DRUG

Radioactive agent

Also known as: DFKZ 11, HBED CC PSMA, Heidelberg compound
68-Ga PSMA11+68-Ga RM268-Ga RM2+68-Ga PSMA11
Investigational software and coils in PET/MR ScanDEVICE

Investigational software and coils in PET/MR Scan by General Electric Healthcare

68-Ga PSMA11+68-Ga RM268-Ga RM2+68-Ga PSMA11
PET/MRIPROCEDURE

Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan

Also known as: Positron emission tomography (PET)/Magnetic resonance imaging (MRI)
68-Ga PSMA11+68-Ga RM268-Ga RM2+68-Ga PSMA11

Eligibility Criteria

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

You may qualify if:

  • Known prostate cancer
  • Planned HIFU or HDR local therapy
  • Able to provide written consent
  • Karnofsky performance status of 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)

You may not qualify if:

  • Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
  • Metallic implants (contraindicated for MRI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Duan H, Ghanouni P, Daniel B, Rosenberg J, Davidzon GA, Aparici CM, Kunder C, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Evaluation of Prostate Cancer Response to High-Intensity Focused Ultrasound Therapy. J Nucl Med. 2023 Apr;64(4):592-597. doi: 10.2967/jnumed.122.264783. Epub 2022 Nov 3.

    PMID: 36328488RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

BAY 86-7548gallium 68 PSMA-11Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Dr. Andrei Iagaru, MD
Organization
Stanford University
aiagaru@stanford.edu
650-725-4711

Study Officials

  • Andrei H Iagaru, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Radiology (Nuclear Medicine)

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 14, 2019

Study Start

April 9, 2019

Primary Completion

March 7, 2022

Study Completion

March 7, 2022

Last Updated

January 30, 2024

Results First Posted

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)