Trial Outcomes & Findings for Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence (NCT NCT02918357)

NCT ID: NCT02918357

Last Updated: 2019-12-02

Results Overview

PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 385 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2019-12-02

Participant Flow

Participant milestones

Measure	Ga-68 Labeled PSMA-11 Positron Emission Tomography (PET) Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the 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.
Overall Study STARTED	385
Overall Study Investigational Drug Administration	385
Overall Study PET/CT Scan	385
Overall Study COMPLETED	385
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

Baseline characteristics by cohort

Measure	Ga-68 Labeled PSMA-11 PET n=385 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the 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.
Age, Customized Age	70 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	385 Participants n=5 Participants
Race/Ethnicity, Customized White	318 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants
Race/Ethnicity, Customized Native American and Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	15 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian	0 Participants n=5 Participants
Race/Ethnicity, Customized Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	14 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	29 Participants n=5 Participants
Region of Enrollment United States	385 participants n=5 Participants
Initial therapy Prostatectomy only	132 Participants n=5 Participants
Initial therapy Radiotherapy only	124 Participants n=5 Participants
Initial therapy Prostatectomy and Salvage Radiotherapy	129 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: All subjects who received a 68Ga-PSMA-11 injection, had their 68Ga-PSMA-11 scan independently and blindly interpreted on a per patient basis. Per patient analyses included an evaluation of positive or negative for presence of localized prostate cancer (PCa).

PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.

Outcome measures

Measure	Pet Positive (Per Patient) n=125 Participants Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy	PSA 0.5 - <1.0 Patients whom have a PSA nadir value of 0.5 to \<1.0	PSA 1.0 - <2.0 Patients whom have a PSA nadir value of 1.0 to \<2.0	PSA 2.0 - <5.0 Patients whom have a PSA nadir value of 2.0 - \<5.0	PSA ≥5.0 Patients whom have a PSA nadir value of ≥5.0
Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation	0.90 percentage of times value is true Interval 0.84 to 0.94	—	—	—	—

PRIMARY outcome

Timeframe: 1 month

Population: All subjects who received a 68Ga-PSMA-11 injection, had their 68Ga-PSMA-11 scan independently and blindly interpreted on a per region basis. Per region analyses included an evaluation of positive or negative for presence of PCa. Regional analyses included prostate bed, pelvic nodes, extrapelvic non-bone, and bone.

PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.

Outcome measures

Measure	Pet Positive (Per Patient) n=120 Participants Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy	PSA 0.5 - <1.0 Patients whom have a PSA nadir value of 0.5 to \<1.0	PSA 1.0 - <2.0 Patients whom have a PSA nadir value of 1.0 to \<2.0	PSA 2.0 - <5.0 Patients whom have a PSA nadir value of 2.0 - \<5.0	PSA ≥5.0 Patients whom have a PSA nadir value of ≥5.0
Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation	0.91 percentage of times value is true Interval 0.85 to 0.95	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: One hundred and twenty-five patients had confirmed imaging at follow-up for this analysis

PPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.

Outcome measures

Measure	Pet Positive (Per Patient) n=125 Participants Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy	PSA 0.5 - <1.0 Patients whom have a PSA nadir value of 0.5 to \<1.0	PSA 1.0 - <2.0 Patients whom have a PSA nadir value of 1.0 to \<2.0	PSA 2.0 - <5.0 Patients whom have a PSA nadir value of 2.0 - \<5.0	PSA ≥5.0 Patients whom have a PSA nadir value of ≥5.0
PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up	0.81 percentage of times value is true Interval 0.69 to 0.89	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Two-hundred and forty-nine patients had confirmed regional imaging in follow up for this sample.

PPVs on a per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.

Outcome measures

Measure	Pet Positive (Per Patient) n=249 Participants Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy	PSA 0.5 - <1.0 Patients whom have a PSA nadir value of 0.5 to \<1.0	PSA 1.0 - <2.0 Patients whom have a PSA nadir value of 1.0 to \<2.0	PSA 2.0 - <5.0 Patients whom have a PSA nadir value of 2.0 - \<5.0	PSA ≥5.0 Patients whom have a PSA nadir value of ≥5.0
PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up	0.92 percentage of times value is true Interval 0.88 to 0.95	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Seventy-nine patients had confirmed patient histopathology validation for this analysis

Sensitivity, on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.

Outcome measures

Measure	Pet Positive (Per Patient) n=79 Participants Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy	PSA 0.5 - <1.0 Patients whom have a PSA nadir value of 0.5 to \<1.0	PSA 1.0 - <2.0 Patients whom have a PSA nadir value of 1.0 to \<2.0	PSA 2.0 - <5.0 Patients whom have a PSA nadir value of 2.0 - \<5.0	PSA ≥5.0 Patients whom have a PSA nadir value of ≥5.0
Sensitivity on a Per-patient Basis	0.92 percentage of sensitivity Interval 0.84 to 0.96	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Eighty-four patients had confirmed histopathology region validation for this analysis

Sensitivity, on a per-region basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.

Outcome measures

Measure	Pet Positive (Per Patient) n=84 Participants Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy	PSA 0.5 - <1.0 Patients whom have a PSA nadir value of 0.5 to \<1.0	PSA 1.0 - <2.0 Patients whom have a PSA nadir value of 1.0 to \<2.0	PSA 2.0 - <5.0 Patients whom have a PSA nadir value of 2.0 - \<5.0	PSA ≥5.0 Patients whom have a PSA nadir value of ≥5.0
Sensitivity on a Per-region Basis	0.90 percentage of sensitivity Interval 0.82 to 0.95	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Portion of patients with 68Ga-PSMA-11 PET positive findings were stratified by PSA range and disease location in accordance with Prostate Magnetic Resonance Imaging Study (PROMIS)

Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-<0.5; 0.5-<1.0; 1.0-<2.0; 2.0-<5.0, and ≥5.0).

Outcome measures

Measure	Pet Positive (Per Patient) n=82 Participants Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy	PSA 0.5 - <1.0 n=41 Participants Patients whom have a PSA nadir value of 0.5 to \<1.0	PSA 1.0 - <2.0 n=53 Participants Patients whom have a PSA nadir value of 1.0 to \<2.0	PSA 2.0 - <5.0 n=103 Participants Patients whom have a PSA nadir value of 2.0 - \<5.0	PSA ≥5.0 n=106 Participants Patients whom have a PSA nadir value of ≥5.0
Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value	40 percentage detected	51 percentage detected	87 percentage detected	83 percentage detected	96 percentage detected

SECONDARY outcome

Timeframe: 1 month

Population: Patients included in the analyses were scanned to include all regions under review

Inter-reader reproducibility for positivity at region level was reported using the Fleiss' Kappa test for multiple readers. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).

Outcome measures

Measure	Pet Positive (Per Patient) n=385 Participants Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy	PSA 0.5 - <1.0 n=385 Participants Patients whom have a PSA nadir value of 0.5 to \<1.0	PSA 1.0 - <2.0 n=385 Participants Patients whom have a PSA nadir value of 1.0 to \<2.0	PSA 2.0 - <5.0 n=385 Participants Patients whom have a PSA nadir value of 2.0 - \<5.0	PSA ≥5.0 Patients whom have a PSA nadir value of ≥5.0
Inter-reader Agreement Per-region	0.65 kappa Interval 0.61 to 0.7	0.73 kappa Interval 0.69 to 0.78	0.70 kappa Interval 0.65 to 0.74	0.78 kappa Interval 0.73 to 0.82	—

SECONDARY outcome

Timeframe: Up to 1 year

Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET.

Outcome measures

Measure	Pet Positive (Per Patient) n=382 Participants Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy	PSA 0.5 - <1.0 Patients whom have a PSA nadir value of 0.5 to \<1.0	PSA 1.0 - <2.0 Patients whom have a PSA nadir value of 1.0 to \<2.0	PSA 2.0 - <5.0 Patients whom have a PSA nadir value of 2.0 - \<5.0	PSA ≥5.0 Patients whom have a PSA nadir value of ≥5.0
Percentage of Participants With Change in Clinical Management	72 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 1 day

Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.

Outcome measures

Measure	Pet Positive (Per Patient) n=385 Participants Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy	PSA 0.5 - <1.0 n=385 Participants Patients whom have a PSA nadir value of 0.5 to \<1.0	PSA 1.0 - <2.0 n=385 Participants Patients whom have a PSA nadir value of 1.0 to \<2.0	PSA 2.0 - <5.0 Patients whom have a PSA nadir value of 2.0 - \<5.0	PSA ≥5.0 Patients whom have a PSA nadir value of ≥5.0
Safety Assessment - Heart Rate	67.8 beats per minute Standard Deviation 13.3	66.9 beats per minute Standard Deviation 13.6	0.9 beats per minute Standard Deviation 11.2	—	—

SECONDARY outcome

Timeframe: 1 day

Population: Pressure exerted by a 1 millimeter vertical column of mercury (Hg) at 0 degree Celsius is defined as (mmHg)

Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.

Outcome measures

Measure	Pet Positive (Per Patient) n=385 Participants Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy	PSA 0.5 - <1.0 n=385 Participants Patients whom have a PSA nadir value of 0.5 to \<1.0	PSA 1.0 - <2.0 n=385 Participants Patients whom have a PSA nadir value of 1.0 to \<2.0	PSA 2.0 - <5.0 Patients whom have a PSA nadir value of 2.0 - \<5.0	PSA ≥5.0 Patients whom have a PSA nadir value of ≥5.0
Safety Assessment - Blood Pressure Systolic blood pressure	137.8 mmHg Standard Deviation 17.7	137.0 mmHg Standard Deviation 17.4	1.0 mmHg Standard Deviation 18.6	—	—
Safety Assessment - Blood Pressure Diastolic blood pressure	80.3 mmHg Standard Deviation 33.8	81.1 mmHg Standard Deviation 10.6	0.6 mmHg Standard Deviation 34.0	—	—

Adverse Events

Ga-68 Labeled PSMA-11 PET

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

University of California, San Francisco

Phone: (415) 221-4810

Email: thomas.hope@ucsf.edu

Results disclosure agreements

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