Trial Outcomes & Findings for Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients (NCT NCT03803475)

NCT ID: NCT03803475

Last Updated: 2021-08-24

Results Overview

Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

485 participants

Primary outcome timeframe

1 day

Results posted on

2021-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	Ga-68 Labeled PSMA-11 PET PSMA Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
Overall Study STARTED	485
Overall Study COMPLETED	484
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ga-68 Labeled PSMA-11 PET PSMA Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
Overall Study Physician Decision	1

Baseline Characteristics

Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ga-68 Labeled PSMA-11 PET PSMA n=485 Participants Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
Age, Continuous	70.13 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	485 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	441 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	408 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	38 Participants n=5 Participants
Region of Enrollment United States	485 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: The Number Analyzed for each Row indicates the number of participants with each detected level of PSA

Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.

Outcome measures

Outcome measures
Measure	Ga-68 Labeled PSMA-11 PET PSMA n=484 Participants Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group PSA Level of 0 to 0.19	0.38 proportion
Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group PSA Level of 0.2 to 0.49	0.45 proportion
Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group PSA Level of 0.5 to 0.99	0.76 proportion
Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group PSA Level of 1 to 1.99	0.73 proportion
Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group PSA Level of 2 to 4.99	0.82 proportion
Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group PSA Level of 5 to maximum	0.62 proportion

PRIMARY outcome

Timeframe: 1 day

Population: The Number Analyzed for each Row indicates the number of participants with each detected level of PSA

Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.

Outcome measures

Outcome measures
Measure	Ga-68 Labeled PSMA-11 PET PSMA n=484 Participants Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group PSA Level of 0 to 0.19	0.14 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group PSA Level of 0.2 to 0.49	0.09 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group PSA Level of 0.5 to 0.99	0.18 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group PSA Level of 1 to 1.99	0.37 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group PSA Level of 2 to 4.99	0.50 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group PSA Level of 5 to maximum	0.76 proportion

PRIMARY outcome

Timeframe: 1 day

Population: The Number Analyzed for each Row indicates the number of participants with each detected level of PSA

Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.

Outcome measures

Outcome measures
Measure	Ga-68 Labeled PSMA-11 PET PSMA n=484 Participants Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group PSA Level of 0 to 0.19	0.10 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group PSA Level of 0.2 to 0.49	0.27 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group PSA Level of 0.5 to 0.99	0.51 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group PSA Level of 1 to 1.99	0.24 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group PSA Level of 2 to 4.99	0.34 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group PSA Level of 5 to maximum	0.37 proportion

PRIMARY outcome

Timeframe: 1 day

Population: The Number Analyzed for each Row indicates the number of participants with each detected level of PSA

Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.

Outcome measures

Outcome measures
Measure	Ga-68 Labeled PSMA-11 PET PSMA n=484 Participants Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group PSA Level of 0 to 0.19	0.10 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group PSA Level of 0.2 to 0.49	0.09 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group PSA Level of 0.5 to 0.99	0.10 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group PSA Level of 1 to 1.99	0.18 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group PSA Level of 2 to 4.99	0.30 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group PSA Level of 5 to maximum	0.21 proportion

PRIMARY outcome

Timeframe: 1 day

Population: The Number Analyzed for each Row indicates the number of participants with each detected level of PSA

Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.

Outcome measures

Outcome measures
Measure	Ga-68 Labeled PSMA-11 PET PSMA n=484 Participants Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group PSA Level of 0 to 0.19	0.03 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group PSA Level of 0.2 to 0.49	0.09 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group PSA Level of 0.5 to 0.99	0.18 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group PSA Level of 1 to 1.99	0.22 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group PSA Level of 2 to 4.99	0.25 proportion
Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group PSA Level of 5 to maximum	0.26 proportion

Adverse Events

Ga-68 Labeled PSMA-11 PET PSMA

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. Thomas Hope, MD

University of California, San Francisco

Phone: (415) 221-4810

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place