Trial Outcomes & Findings for 68Ga PSMA in Preprostatectomy Patients (NCT NCT03388346)

NCT ID: NCT03388346

Last Updated: 2024-02-15

Results Overview

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 22 participants
• Primary outcome timeframe: within 2 weeks of prostatectomy
• Results posted on: 2024-02-15

Participant Flow

Participant milestones

Measure	68Ga PSMA PET Scan Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

68Ga PSMA in Preprostatectomy Patients

Baseline characteristics by cohort

Measure	68Ga PSMA PET Scan n=22 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	64.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 2 weeks of prostatectomy

Population: 21 of the 22 subjects had a prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=21 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Regional Pelvic Nodal Metastases on a Per Patient Basis	.5 proportion of participants

PRIMARY outcome

Timeframe: within 2 weeks of prostatectomy

Population: 21 of the 22 subjects had a prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=21 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Regional Pelvic Nodal Metastases on a Per Patient Basis	.89 proportion of participants

PRIMARY outcome

Timeframe: within 2 weeks of prostatectomy

Population: 21 of the 22 subjects had a prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=21 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Regional Pelvic Nodal Metastases on a Per Patient Basis	.33 proportion of true positives

PRIMARY outcome

Timeframe: within 2 weeks of prostatectomy

Population: 21 of the 22 subjects had a prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=21 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Negative Predictive Value (NPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Regional Pelvic Nodal Metastases on a Per Patient Basis	.94 proportion of true negative

SECONDARY outcome

Timeframe: Within 12 months of prostatectomy

Population: 15 of the 22 subjects had no standard of care follow-up imaging, which removed a large proportion of patients from imaging follow-up analysis.

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=7 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis	0 proportion of participants

SECONDARY outcome

Timeframe: Within 12 months of prostatectomy

Population: 15 of the 22 subjects had no standard of care follow-up imaging, which removed a large proportion of patients from imaging follow-up analysis.

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=7 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis	0.71 proportion of participants

SECONDARY outcome

Timeframe: Within 12 months of prostatectomy

Population: 15 of the 22 subjects had no standard of care follow-up imaging, which removed a large proportion of patients from imaging follow-up analysis.

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=7 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis	0 proportion of true positives

SECONDARY outcome

Timeframe: Within 12 months of prostatectomy

Population: 15 of the 22 subjects had no standard of care follow-up imaging, which removed a large proportion of patients from imaging follow-up analysis.

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=7 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Negative Predictive Value (NPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis	1.0 proportion of true negatives

SECONDARY outcome

Timeframe: Within 12 months of prostatectomy

Population: 15 of the 22 subjects had no standard of care follow-up imaging, which removed a large proportion of patients from imaging follow-up analysis.

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=7 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis	0 proportion of participants

SECONDARY outcome

Timeframe: Within 12 months of prostatectomy

Population: 15 of the 22 subjects had no standard of care follow-up imaging, which removed a large proportion of patients from imaging follow-up analysis.

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=7 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis	1.0 proportion of participants

SECONDARY outcome

Timeframe: Within 12 months of prostatectomy

Population: 15 of the 22 subjects had no standard of care follow-up imaging, which removed a large proportion of patients from imaging follow-up analysis.

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=7 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis	0 proportion of true positives

SECONDARY outcome

Timeframe: Within 12 months of prostatectomy

Population: 15 of the 22 subjects had no standard of care follow-up imaging, which removed a large proportion of patients from imaging follow-up analysis.

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=7 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Negative Predictive Value (NPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis	1.0 proportion of true negatives

SECONDARY outcome

Timeframe: Within 12 months of prostatectomy

Population: 14 of the 22 subjects had no standard of care follow-up imaging, which removed a large proportion of patients from imaging follow-up analysis.

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=8 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Osseous Metastases on a Per Patient Basis	0 proportion of participants

SECONDARY outcome

Timeframe: Within 12 months of prostatectomy

Population: 14 of the 22 subjects had no standard of care follow-up imaging, which removed a large proportion of patients from imaging follow-up analysis.

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=8 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Osseous Metastases on a Per Patient Basis	1.0 proportion of participants

SECONDARY outcome

Timeframe: Within 12 months of prostatectomy

Population: 14 of the 22 subjects had no standard of care follow-up imaging, which removed a large proportion of patients from imaging follow-up analysis.

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=8 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Osseous Metastases on a Per Patient Basis	0 proportion of true positives

SECONDARY outcome

Timeframe: Within 12 months of prostatectomy

Population: 14 of the 22 subjects had no standard of care follow-up imaging, which removed a large proportion of patients from imaging follow-up analysis.

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Outcome measures

Measure	68Ga PSMA PET Scan n=8 Participants Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Negative Predictive Value (NPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Osseous Metastases on a Per Patient Basis	1.0 proportion of true negatives

Adverse Events

68Ga PSMA PET Scan

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	68Ga PSMA PET Scan n=22 participants at risk Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Surgical and medical procedures Surgical and medical procedures - Other, specify	4.5% 1/22 • Number of events 1 • 24 hours

Additional Information

Dr. Michael Graham

UIHC

Phone: 319-356-4302

Email: michael-graham@uiowa.edu

Results disclosure agreements

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