Trial Outcomes & Findings for 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer (NCT NCT03809078)

NCT ID: NCT03809078

Last Updated: 2024-01-11

Results Overview

Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: Up to approximately 2 hours to complete each scan
• Results posted on: 2024-01-11

Participant Flow

Participant milestones

Measure	68Ga PSMA11 First Followed by 68Ga RM2 Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2.	68Ga RM2 First Followed by 68Ga PSMA11 Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11.
First Scan STARTED	7	7
First Scan COMPLETED	7	7
First Scan NOT COMPLETED	0	0
Second Scan STARTED	6	7
Second Scan COMPLETED	6	7
Second Scan NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

Baseline characteristics by cohort

Measure	68Ga PSMA11 First Followed by 68Ga RM2 n=7 Participants Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2.	68Ga RM2 First Followed by 68Ga PSMA11 n=7 Participants Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11.	Total n=14 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 4.4 • n=5 Participants	55.7 years STANDARD_DEVIATION 7.3 • n=7 Participants	59.6 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 2 hours to complete each scan

Population: Participants who completed both scans and who had biopsy done are included in the analysis.

Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).

Outcome measures

Measure	68Ga PSMA11 n=13 Participants 68Ga PSMA11 scan prior to biopsy	68Ga RM2 n=13 Participants 68Ga RM2 scan prior to biopsy
Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings	13 Participants	13 Participants

Adverse Events

68Ga PSMA11

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

68Ga RM2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrei Iagaru, MD

Stanford University

Phone: 650-725-4711

Email: aiagaru@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place