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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03803475

Enrollment

485

Registered

2019-01-14

Start date

2018-10-11

Completion date

2020-08-25

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.

Detailed description

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. PET imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues Primary Objective: Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

Interventions

DRUGGa-68 labeled PSMA-11

DEVICEPositron emission tomography-computed tomography (PET/CT)

Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session

DEVICEPositron emission tomography-magnetic resonance imaging (PET/MRI)

A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male, age \>= 18. 2. Histopathologically proven prostate adenocarcinoma. 3. Concern for metastatic disease in one of the following settings: 1. Initial staging with intermediate to high risk prostate cancer. 2. Biochemical recurrence after initial therapy. 4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

1\. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

Design outcomes

Primary

Measure	Time frame	Description
Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group	1 day	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.
Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group	1 day	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.
Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group	1 day	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.
Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group	1 day	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.
Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group	1 day	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	485
Total	485

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Physician Decision	1

Baseline characteristics

Characteristic	Ga-68 Labeled PSMA-11 PET PSMA
Age, Continuous	70.13 years
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	441 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	28 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	26 Participants
Race (NIH/OMB) Black or African American	8 Participants
Race (NIH/OMB) More than one race	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants
Race (NIH/OMB) Unknown or Not Reported	38 Participants
Race (NIH/OMB) White	408 Participants
Region of Enrollment United States	485 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	485 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 485
other Total, other adverse events	0 / 485
serious Total, serious adverse events	0 / 485

Outcome results

Primary

Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group

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.

Time frame: 1 day