Trial Outcomes & Findings for Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence (NCT NCT03396874)

Last Updated: 2023-11-03

Results Overview

Evaluation of the positive predictive value (PPV) (true positives / (true positives + false positives)) of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by histopathology on a per-patient basis. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%. The result of a histopathological examination of a PSMA positive lesion is obtained when available. Such data are collected as a single time point up to 12 months following the scan.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1435 participants

Primary outcome timeframe

Up to 12 months after 68Ga-PSMA scan

Results posted on

2023-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	68Ga-PSMA Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate.	Physicians Participants were the ordering physicians/practitioners of the patient participants in the 68Ga-PSMA study arm.
Overall Study STARTED	1181	254
Overall Study 68Ga-PSMA Scan	1181	0
Overall Study COMPLETED	1181	254
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age data not collected for the Physicians Arm

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 12 months after 68Ga-PSMA scan

Population: The participants analyzed were all those who had histopathological confirmation. Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate.

Outcome measures

Outcome measures
Measure	68Ga-PSMA n=151 Participants PET/CT imaging 68Ga-PSMA: PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).	Treatment Plans At The End of the Study (One Year Post Scan) Final treatment plan based on surveys or the electronic medical record (obtained between 3 - 12 months after the 68Ga-PSMA-11 PET scan).
Positive Predictive Value (PPV) of 68Ga PSMA PET/CT for Detecting Prostate Cancer on a Per-patient Basis Confirmed by Histopathology.	87.3 percentage of times value is true Interval 81.58 to 100.0	—

SECONDARY outcome

Timeframe: Up to 12 months after 68Ga-PSMA scan

Population: Participants analyzed were all those where either conventional imaging, clinical follow-up, or histopathology was available. Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate.

The sensitivity and PPV of 68Ga-PSMA PET/CT is determined on a per-patient and per-region-basis for the detection of tumor location. Confirmation is obtained by conventional imaging, clinical follow-up, and/or histopathology/biopsy where available. Results of conventional imaging, clinical follow-up, and/or histopathology is collected as a single time point up to 12 months following the scan.

Outcome measures

Outcome measures
Measure	68Ga-PSMA n=516 Participants PET/CT imaging 68Ga-PSMA: PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).	Treatment Plans At The End of the Study (One Year Post Scan) Final treatment plan based on surveys or the electronic medical record (obtained between 3 - 12 months after the 68Ga-PSMA-11 PET scan).
Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. PPV, Per-Participant Basis	92.3 percentage of times value is true Interval 90.0 to 100.0	—
Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. Sensitivity, Per-Participant Basis	95.29 percentage of times value is true Interval 93.3 to 100.0	—
Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. PPV, prostate or prostate bed	91.1 percentage of times value is true Interval 86.2 to 100.0	—
Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. Sensitivity, prostate or prostate bed	91.72 percentage of times value is true Interval 86.74 to 100.0	—
Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. PPV, pelvic lymph nodes	90.78 percentage of times value is true Interval 85.74 to 100.0	—
Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. Sensitivity, pelvic lymph nodes	96.97 percentage of times value is true Interval 93.2 to 100.0	—
Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. PPV, soft tissues	91.25 percentage of times value is true Interval 84.19 to 100.0	—
Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. Sensitivity, soft tissues	93.59 percentage of times value is true Interval 86.99 to 100.0	—
Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. PPV, bone	95.17 percentage of times value is true Interval 91.12 to 100.0	—
Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. Sensitivity, bone	100 percentage of times value is true Interval 97.85 to 100.0	—

SECONDARY outcome

Timeframe: 24 - 72 hours post administration

Population: Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate and received a 68Ga-PSMA-11 PET/CT scan.

The number of adverse events were determined through clinical assessment and categorized by CTCAE 4.0.

Outcome measures

Outcome measures
Measure	68Ga-PSMA n=1181 Participants PET/CT imaging 68Ga-PSMA: PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).	Treatment Plans At The End of the Study (One Year Post Scan) Final treatment plan based on surveys or the electronic medical record (obtained between 3 - 12 months after the 68Ga-PSMA-11 PET scan).
Adverse Events of 68Ga-PSMA Administration Serious adverse events	1 events	—
Adverse Events of 68Ga-PSMA Administration Adverse events	2 events	—

SECONDARY outcome

Timeframe: 12 months post scan

Population: Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy, or focal therapy of the prostate.

Scan detection rates (in %) on a per-patient basis are given for specific PSA value ranges (a) 0.2\<0.5, b) 0.5\<1.0, c) 1.0\<2.0, d) 2.0\<5.0, e) \>=5.0 ng/mL. Ideally, the 68Ga-PSMA-11 PET/CT scan detection rate would be 100% at any PSA range.

Outcome measures

Outcome measures
Measure	68Ga-PSMA n=1181 Participants PET/CT imaging 68Ga-PSMA: PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).	Treatment Plans At The End of the Study (One Year Post Scan) Final treatment plan based on surveys or the electronic medical record (obtained between 3 - 12 months after the 68Ga-PSMA-11 PET scan).
Detection Rates on a Per-patient Basis of 68Ga-PSMA-11 PET/CT PSA range 0.2 - < 0.5 ng/mL.	55.1 percentage of positive scans	—
Detection Rates on a Per-patient Basis of 68Ga-PSMA-11 PET/CT PSA range 0.5 - < 1.0 ng/mL.	71.2 percentage of positive scans	—
Detection Rates on a Per-patient Basis of 68Ga-PSMA-11 PET/CT PSA range 1.0 - < 2.0 ng/mL.	85.5 percentage of positive scans	—
Detection Rates on a Per-patient Basis of 68Ga-PSMA-11 PET/CT PSA range 2.0 - < 5.0 ng/mL.	91.1 percentage of positive scans	—
Detection Rates on a Per-patient Basis of 68Ga-PSMA-11 PET/CT PSA range 5.0 and above ng/mL.	95.4 percentage of positive scans	—

SECONDARY outcome

Timeframe: 2 days to 12 months following the scan.

Population: The intention was to count the number of prostate cancer patients and whether their treatment plans changed post scan based on physician survey responses and the participant's electronic medical record. Not all the physicians responded to surveys, and electronic records were not available for all participants, meaning data are missing for some patients.

The results of this outcome measure were evaluated using a treatment plan questionnaire given to the treating physician or practitioner before the scan, at approximately 1 month (2-30 days) after the 68Ga-PSMA-11 PET scan, and at approximately 6 months (range 3 - 12 months) after the 68Ga-PSMA-11 PET scan. The treatment plan questionnaire was provided with 11 choice options. Responses to the questionnaire were compared to determine whether physicians changed their treatment plans following the PET scan.

Outcome measures

Outcome measures
Measure	68Ga-PSMA n=1181 Participants PET/CT imaging 68Ga-PSMA: PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).	Treatment Plans At The End of the Study (One Year Post Scan) n=1181 Participants Final treatment plan based on surveys or the electronic medical record (obtained between 3 - 12 months after the 68Ga-PSMA-11 PET scan).
Impact of 68Ga-PSMA-11 PET on Clinical Management in BCR Patients Change in management from time before the scan	886 Participants	374 Participants
Impact of 68Ga-PSMA-11 PET on Clinical Management in BCR Patients No change in management from time before the scan	294 Participants	594 Participants
Impact of 68Ga-PSMA-11 PET on Clinical Management in BCR Patients Missing Data	1 Participants	213 Participants

Adverse Events

68Ga-PSMA

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	68Ga-PSMA n=1181 participants at risk Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate.
Cardiac disorders Coronary artery disease	0.08% 1/1181 • Number of events 1 • Patients were monitored for adverse events during and for 90 minutes after 68Ga-PSMA-11 administration. Patients were also contacted by phone to assess for the development of delayed adverse events up 3 days after 68Ga-PSMA-11 administration. Physicians received no intervention; therefore no adverse event data were collected.

Other adverse events

Other adverse events
Measure	68Ga-PSMA n=1181 participants at risk Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate.
Cardiac disorders Dizziness	0.08% 1/1181 • Number of events 1 • Patients were monitored for adverse events during and for 90 minutes after 68Ga-PSMA-11 administration. Patients were also contacted by phone to assess for the development of delayed adverse events up 3 days after 68Ga-PSMA-11 administration. Physicians received no intervention; therefore no adverse event data were collected.
General disorders Pain	0.08% 1/1181 • Number of events 1 • Patients were monitored for adverse events during and for 90 minutes after 68Ga-PSMA-11 administration. Patients were also contacted by phone to assess for the development of delayed adverse events up 3 days after 68Ga-PSMA-11 administration. Physicians received no intervention; therefore no adverse event data were collected.

Additional Information

Morand Piert

University of Michigan

Phone: 734-936-5385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	68Ga-PSMA n=1181 Participants Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate.	Physicians n=254 Participants Participants were the ordering physicians/practitioners of the patient participants in the 68Ga-PSMA study arm.	Total n=1435 Participants Total of all reporting groups
Age, Continuous Age	69.4 years STANDARD_DEVIATION 7.0 • n=1181 Participants • Age data not collected for the Physicians Arm	—	69.4 years STANDARD_DEVIATION 7.0 • n=1181 Participants • Age data not collected for the Physicians Arm
Sex: Female, Male Female	0 Participants n=1181 Participants • Sex: all male given disease (prostate cancer participants). Sex data not collected for the Physicians Arm.	0 Participants Sex: all male given disease (prostate cancer participants). Sex data not collected for the Physicians Arm.	0 Participants n=1181 Participants • Sex: all male given disease (prostate cancer participants). Sex data not collected for the Physicians Arm.
Sex: Female, Male Male	1181 Participants n=1181 Participants • Sex: all male given disease (prostate cancer participants). Sex data not collected for the Physicians Arm.	0 Participants Sex: all male given disease (prostate cancer participants). Sex data not collected for the Physicians Arm.	1181 Participants n=1181 Participants • Sex: all male given disease (prostate cancer participants). Sex data not collected for the Physicians Arm.
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=1181 Participants • Ethnicity data not collected for the Physicians Arm	—	6 Participants n=1181 Participants • Ethnicity data not collected for the Physicians Arm
Ethnicity (NIH/OMB) Not Hispanic or Latino	1175 Participants n=1181 Participants • Ethnicity data not collected for the Physicians Arm	—	1175 Participants n=1181 Participants • Ethnicity data not collected for the Physicians Arm
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=1181 Participants • Ethnicity data not collected for the Physicians Arm	—	0 Participants n=1181 Participants • Ethnicity data not collected for the Physicians Arm
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1181 Participants • Race data not collected for the Physicians Arm	—	0 Participants n=1181 Participants • Race data not collected for the Physicians Arm
Race (NIH/OMB) Asian	7 Participants n=1181 Participants • Race data not collected for the Physicians Arm	—	7 Participants n=1181 Participants • Race data not collected for the Physicians Arm
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1181 Participants • Race data not collected for the Physicians Arm	—	0 Participants n=1181 Participants • Race data not collected for the Physicians Arm
Race (NIH/OMB) Black or African American	99 Participants n=1181 Participants • Race data not collected for the Physicians Arm	—	99 Participants n=1181 Participants • Race data not collected for the Physicians Arm
Race (NIH/OMB) White	1060 Participants n=1181 Participants • Race data not collected for the Physicians Arm	—	1060 Participants n=1181 Participants • Race data not collected for the Physicians Arm
Race (NIH/OMB) More than one race	14 Participants n=1181 Participants • Race data not collected for the Physicians Arm	—	14 Participants n=1181 Participants • Race data not collected for the Physicians Arm
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=1181 Participants • Race data not collected for the Physicians Arm	—	1 Participants n=1181 Participants • Race data not collected for the Physicians Arm
Region of Enrollment United States	1181 Participants n=1181 Participants	254 Participants n=254 Participants	1435 Participants n=1435 Participants
Weight	91.2 kg STANDARD_DEVIATION 17.3 • n=1181 Participants • Weight data not collected for the Physicians Arm	—	91.2 kg STANDARD_DEVIATION 17.3 • n=1181 Participants • Weight data not collected for the Physicians Arm
Height	177.5 cm STANDARD_DEVIATION 8.7 • n=1181 Participants • Height data not collected for the Physicians Arm	—	177.5 cm STANDARD_DEVIATION 8.7 • n=1181 Participants • Height data not collected for the Physicians Arm