Trial Outcomes & Findings for HDR Brachytherapy 68-Ga-RM2 PET, 68-Ga-PSMA-11 PET &Multi Parametric MRI in Prostate Cancer (NCT NCT04264208)

Last Updated: 2024-02-01

Results Overview

Assessment of whether 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 PSMA11 and 68Ga RM2 PET scans.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment

Results posted on

2024-02-01

Participant Flow

4 participants signed consent and three participants were randomized to treatment.

Participant milestones

Participant milestones
Measure	68Ga-RM2 PET MRI Then 68Ga PSMA 11 PET/MRI Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PSMA 11 PET/MRI.	68Ga-PSMA-11 PET MRI Then 68Ga-RM2 PET MRI Subjects will undergo 68Ga PSMA 11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI.
Pre-HDR Scan Sequence STARTED	1	2
Pre-HDR Scan Sequence Received First Scan in Sequence	1	2
Pre-HDR Scan Sequence Received Second Scan in Sequence	0	1
Pre-HDR Scan Sequence COMPLETED	1	2
Pre-HDR Scan Sequence NOT COMPLETED	0	0
HDR Treatment at 2 Months STARTED	1	2
HDR Treatment at 2 Months COMPLETED	1	2
HDR Treatment at 2 Months NOT COMPLETED	0	0
Post-HDR Scan Sequence at 10 Months STARTED	1	2
Post-HDR Scan Sequence at 10 Months Received First Scan in Sequence	0	1
Post-HDR Scan Sequence at 10 Months Received Second Scan in Sequence	0	1
Post-HDR Scan Sequence at 10 Months COMPLETED	1	2
Post-HDR Scan Sequence at 10 Months NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	68Ga-RM2 PET MRI Then 68Ga PSMA 11 PET/MRI n=1 Participants Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PSMA11 PET/MRI.	68Ga-PSMA-11 PET MRI Then 68Ga-RM2 PET MRI n=2 Participants Subjects will undergo 68Ga PSMA 11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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
Region of Enrollment United States	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment

Population: Participants with pre HDR treatment scan data

Assessment of whether 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 PSMA11 and 68Ga RM2 PET scans.

Outcome measures

Outcome measures
Measure	68Ga-RM2 PET MRI n=2 Participants Subjects receive 68Ga RM2 PET/MRI.	68Ga-PSMA-11 PET MRI n=2 Participants Subjects receive 68Ga PSMA11 PET/MRI.
Number of Participants With Successful Assessment of PET Based PC Lesions	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment

Population: Participants who received post HDR scan

Assessment of whether 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. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	68Ga-RM2 PET MRI n=1 Participants Subjects receive 68Ga RM2 PET/MRI.	68Ga-PSMA-11 PET MRI n=1 Participants Subjects receive 68Ga PSMA11 PET/MRI.
Number of Participants for Which an Assessment of PET Based Therapeutic Response to HDR is Successfully Obtained	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 24 months

Population: No participant had month 24 data (all discontinued prior)

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.

Outcome measures

Outcome data not reported

Adverse Events

68Ga-RM2 PET MRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

68Ga-PSMA-11 PET MRI

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

Andrei Iagaru, MD

Stanford University

Phone: (650) 725-4711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place