Trial Outcomes & Findings for 68Ga PSMA PET for Patients With Biochemical Recurrence of Prostate Cancer (NCT NCT03389451)

NCT ID: NCT03389451

Last Updated: 2024-07-12

Results Overview

Sensitivity will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

30 participants

Primary outcome timeframe

Up to 12 months after 68Ga PSMA PET scan

Results posted on

2024-07-12

Participant Flow

Participant milestones

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	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

68Ga PSMA PET for Patients With Biochemical Recurrence of Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	68Ga PSMA PET Scan n=30 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 >=65 years	23 Participants n=5 Participants
Age, Continuous	69 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants

PRIMARY outcome

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

Population: 21 of the 30 subjects had a positive PET/CT scan. 9 of the 21 positive PET/CT scan had enough information to evaluate the results.

Sensitivity will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Outcome measures

Outcome measures
Measure	68Ga PSMA PET Scan n=9 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 on a Per Patient Basis	1.0 proportion of participants

SECONDARY outcome

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

Population: 21 of the 30 subjects had a positive PET/CT scan. 9 of the 21 positive PET/CT scan had enough information to evaluate the results.

Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Outcome measures

Outcome measures
Measure	68Ga PSMA PET Scan n=9 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 Tumor Location on a Per Patient Basis	1.0 proportion of true positives

SECONDARY outcome

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

Population: 21 of the 30 subjects had a positive PET/CT scan. Five of the 21 positive PET/CT scan had prostate bed lesions, however, only 1 subject had histopathology or Conventional Imaging to confirm positivity.

Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Outcome measures

Outcome measures
Measure	68Ga PSMA PET Scan n=1 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 Prostate Bed Lesions on a Per Patient Basis	1.0 proportion of true positives

SECONDARY outcome

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

Population: 21 of the 30 subjects had a positive PET/CT scan. Fifteen of the 21 positive PET/CT scan had regional pelvic nodal metastases, however, only 7 subjects had histopathology or Conventional Imaging to confirm positivity.

Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Outcome measures

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 Regional Pelvic Nodal Metastases on a Per Patient Basis	1.0 proportion of true positives

SECONDARY outcome

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

Population: 21 of the 30 subjects had a positive PET/CT scan. 0 of the 21 positive PET/CT scan had detected Extra-pelvic/Visceral Nodal Metastases

Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: 21 of the 30 subjects had a positive PET/CT scan. Six of the 21 positive PET/CT scan had osseous metastases, however, only 2 subject had histopathology or Conventional Imaging to confirm positivity.

Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Outcome measures

Outcome measures
Measure	68Ga PSMA PET Scan n=2 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	1.0 proportion of true positives

Adverse Events

68Ga PSMA PET Scan

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. Michael Graham

University of Iowa Health Care

Phone: 319-356-4302

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place