NCT03388346

68Ga PSMA in Preprostatectomy Patients

Completed Phase 2, PHASE3 Results posted Last updated 15 February 2024

What this trial tests

Phase 2, PHASE3 trial testing Ga-68 PSMA-HBED-CC PET in Prostate Cancer in 22 participants. Completed in 22 July 2021.

Timeline

16 February 2018

Primary endpoint
22 July 2021

22 July 2021

Quick facts

Lead sponsor	Michael Graham PhD, MD
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	22
Start date	16 February 2018
Primary completion	22 July 2021
Estimated completion	22 July 2021
Sites	1 location across United States

Drugs / interventions tested

• Ga-68 PSMA-HBED-CC PET — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →
• Prostatic Neoplasm — all drugs for Prostatic Neoplasm →
• Prostatic Neoplasms, Castration-Resistant — all drugs for Prostatic Neoplasms, Castration-Resistant →
• Prostatic Neoplasm of Uncertain Behavior — all drugs for Prostatic Neoplasm of Uncertain Behavior →

Sponsor

Michael Graham PhD, MD — full company profile →

Who can join

18 and older, male only, with Prostate Cancer or Prostatic Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sensitivity 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 Primary · within 2 weeks of prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Group	Value	95% CI
68Ga PSMA PET Scan	.5

Specificity 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 Primary · within 2 weeks of prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Group	Value	95% CI
68Ga PSMA PET Scan	.89

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 Primary · within 2 weeks of prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Group	Value	95% CI
68Ga PSMA PET Scan	.33

Negative Predictive Value (NPV) 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 Primary · within 2 weeks of prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Group	Value	95% CI
68Ga PSMA PET Scan	.94

Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis Secondary · Within 12 months of prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Group	Value	95% CI
68Ga PSMA PET Scan	0

Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis Secondary · Within 12 months of prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Group	Value	95% CI
68Ga PSMA PET Scan	0.71

Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis Secondary · Within 12 months of prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Group	Value	95% CI
68Ga PSMA PET Scan	0

Negative Predictive Value (NPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis Secondary · Within 12 months of prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Group	Value	95% CI
68Ga PSMA PET Scan	1.0

Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis Secondary · Within 12 months of prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Group	Value	95% CI
68Ga PSMA PET Scan	0

Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis Secondary · Within 12 months of prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Group	Value	95% CI
68Ga PSMA PET Scan	1.0

Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis Secondary · Within 12 months of prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Group	Value	95% CI
68Ga PSMA PET Scan	0

Negative Predictive Value (NPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis Secondary · Within 12 months of prostatectomy

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.

Group	Value	95% CI
68Ga PSMA PET Scan	1.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 hours. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

68Ga PSMA PET Scan

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (1 terms — click to expand)

Reaction	System	68Ga PSMA PET Scan
Surgical and medical procedures - Other, specify	Surgical and medical procedures	—

Data from ClinicalTrials.gov NCT03388346 adverse events section.

Sponsor's own description

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker.

To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Review of Gallium-68 PSMA PET/CT Imaging in the Management of Prostate Cancer.
   Lenzo NP, Meyrick D, Turner JH. · · 2018 · cited 71× · PMID 29439481 · DOI 10.3390/diagnostics8010016
2. Early Diagnosis of Prostate Cancer from the Perspective of Chinese Physicians.
   Yu W, Zhou L. · · 2020 · cited 9× · PMID 32231732 · DOI 10.7150/jca.36697