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HDR Brachytherapy 68-Ga-RM2 PET, 68-Ga-PSMA-11 PET &Multi Parametric MRI in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
68-Ga RM2.
68-Ga PSMA11
PET/MRI
Sponsored by
Andrei Iagaru
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must be at least 18 years of age;
  • Patients must be able to provide informed consent;
  • Histologically proven low-grade or intermediate-grade prostate cancer (PC)
  • Scheduled to undergo targeted local therapy (HDR brachytherapy).

Exclusion Criteria:

  • Inability to lie still for the entire imaging time;
  • 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;
  • Metallic implants (contraindicated for MRI).

Sites / Locations

  • Stanford Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

68Ga-RM2 PET MRI/68Ga PMSA11 PET/MRI

68Ga-PSMA-11 PET MRI/68Ga-RM2 PET MRI

Arm Description

Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PMSA11 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)

Subjects will undergo 68Ga PMSA11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)

Outcomes

Primary Outcome Measures

68-Ga-RM2 and 68-Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI
Detection of PC lesions will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. The outcome is the number of participants without dispersion, by randomization schedule, for which an assessment of PET based PC lesions is successfully obtained.
68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment
Therapeutic response to HDR will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. The outcome is the number of participants without dispersion, by randomization schedule, for which an assessment of PET based therapeutic response to HDR is successfully obtained.
Progression free survival (PFS)
Progression-free survival (PFS) will be assessed as survival without progression at 24 months. The outcome is reported as the number (without dispersion) of the participants alive without progression.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2020
Last Updated
September 18, 2023
Sponsor
Andrei Iagaru
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04264208
Brief Title
HDR Brachytherapy 68-Ga-RM2 PET, 68-Ga-PSMA-11 PET &Multi Parametric MRI in Prostate Cancer
Official Title
Evaluation of Patients With Low-Risk and Intermediate-Risk Prostate Cancer Scheduled for High-Dose Rate Brachytherapy Using 68-Ga-RM2 PET, 68Ga-PSMA-11 PET and Multi Parametric MRI
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
November 22, 2022 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrei Iagaru
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)

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 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 dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer (PC)
Detailed Description
Primary Objective: To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI. To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment and predict progression free survival (PFS) at 24 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
68Ga-RM2 PET MRI/68Ga PMSA11 PET/MRI
Arm Type
Experimental
Arm Description
Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PMSA11 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
Arm Title
68Ga-PSMA-11 PET MRI/68Ga-RM2 PET MRI
Arm Type
Experimental
Arm Description
Subjects will undergo 68Ga PMSA11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
Intervention Type
Drug
Intervention Name(s)
68-Ga RM2.
Other Intervention Name(s)
BAY86 7548, 68Ga DOTA Bombesin
Intervention Description
PET radiopharmaceutical
Intervention Type
Drug
Intervention Name(s)
68-Ga PSMA11
Other Intervention Name(s)
DFKZ 11, HBED CC PSMA, Heidelberg compound
Intervention Description
PET radiopharmaceutical
Intervention Type
Device
Intervention Name(s)
PET/MRI
Other Intervention Name(s)
PET/MR scanner
Intervention Description
PET/MR scanner by GE healthcare
Primary Outcome Measure Information:
Title
68-Ga-RM2 and 68-Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI
Description
Detection of PC lesions will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. The outcome is the number of participants without dispersion, by randomization schedule, for which an assessment of PET based PC lesions is successfully obtained.
Time Frame
60 months
Title
68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment
Description
Therapeutic response to HDR will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. The outcome is the number of participants without dispersion, by randomization schedule, for which an assessment of PET based therapeutic response to HDR is successfully obtained.
Time Frame
84 months
Title
Progression free survival (PFS)
Description
Progression-free survival (PFS) will be assessed as survival without progression at 24 months. The outcome is reported as the number (without dispersion) of the participants alive without progression.
Time Frame
24 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be at least 18 years of age; Patients must be able to provide informed consent; Histologically proven low-grade or intermediate-grade prostate cancer (PC) Scheduled to undergo targeted local therapy (HDR brachytherapy). Exclusion Criteria: Inability to lie still for the entire imaging time; 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; Metallic implants (contraindicated for MRI).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei H Iagaru, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HDR Brachytherapy 68-Ga-RM2 PET, 68-Ga-PSMA-11 PET &Multi Parametric MRI in Prostate Cancer

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