Diagnostic Accuracy and Performance of 18F-PSMA-1007

Diagnostic Accuracy and Performance of 18F-PSMA-1007 in the Detection of Recurrent Prostate Cancer - a Prospective, Single-arm Study

Whereas 18F-PSMA-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. The purpose of this study is to determine the diagnostic performance for this radiotracer.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: [18F]PSMA-1007

Detailed Description

In this prospective, single-armed diagnostic imaging study men undergoing standard-of-care PSMA PET/CT using [18F]PSMA-1007 shall be studied. The primary objective is to confirm the positive predictive value (PPV) of this tracer at a patient-based level by recruiting until 53 patients with follow-up to a composite reference standard are available. Secondary outcomes shall include patient based rate of pathological-scans stratified by PSA, the PPV stratified by region , interrelate agreement, frequency of indeterminate lesions and the safety and tolerability of the examination.

• Study Type: Observational
• Enrollment (Actual): 174

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitätsspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The data will be obtained prospectively from patients referred for routine 18F-PSMA-11 PET/CT for recurrent prostate cancer at the university clinic for nuclear medicine, Inselspital Bern. Follow up data (further imaging, laboratory parameters and details of further treatment) will be collected up to 12 months' follow up from the date of examination.

Description

Inclusion Criteria:

• Adult Patients referred for investigation of recurrent PC by PSMA PET/CT.
• Patients with known biochemical recurrence of a histologically confirmed primary prostate cancer, defined as:

Post prostatectomy: two consecutive PSA > 0.2 ng/ml Post-radiotherapy: a rise of 2ng/mL > post-therapy nadir (ASTRO consensus definition)

• Male patients >18 years old
• PSA measured ± 4 weeks of the PSMA-PET/CT
• Patients willing and able to consent to the informed consent document

Exclusion Criteria:

• Patients with ADT within 6 months prior to the PSMA-PET/CT
• Inability to provide informed, written consent
• Patients undergoing active treatment for a second non-prostatic malignancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Arm; Arm 1 - All patients will undergo PET/CT with 18F-PSMA-1007	Diagnostic test: [18F]PSMA-1007; PSMA PET/CT using the intervention.; Other Names: F-18-PSMA-1007

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary objective: To confirm the PPV of the new tracer (patient-based PPV)	The primary end point is the per patient PPV for the detection of PSMA-positive tumour lesions as confirmed by either a) histology or b) a composite reference standard of imaging and/or PSA fall following focal therapy in the absence of systemic therapy.	At one year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• To determine the patient-based detection rate of pathologic scans (sensitivity) for the new tracer	Patient based detection (PET-positivity) rate (stratified by PSA value)	Within one week of scan
To explore the regional based PPV	Region-based PPV (prostate bed, pelvic lymph nodes, extra-pelvic lymph nodes, extra-pelvic viscera and bone metastases)	At one year follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To calculate the inter-reader reliability	The interrater agreement (ordinal scale, no units) for PET-findings will be determined. The joint-interrate reliability will be compared by a combined assessment of Fleiss' kappa and Krippendorf's alpha.	Within one month of scan
Frequency of diagnostic pitfalls or indeterminate lesions requiring follow-up	The frequency of indeterminate lesions requiring follow up / indeterminate lesions will be recorded by all readers and analysed by descriptive statistics	Within one month of scan
Number of patients with adverse events.	Patients will be contacted by phone one to three days post imaging and assessed for adverse events (AE). Any reported events will be followed up by a physician in the clinic for study related adverse events requiring further evaluation. Adverse events are as defined in supplementary materials and will be recorded using the AE form in the eCRF.	Up to 48 hours follow up post scan

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Chair: Ali Afshar-Oromieh, MD, Deputy Clinic Director

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Actual): September 12, 2022
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: PSMA; Diagnostic accuracy; 18F-PSMA-1007; [18F]PSMA-1007; Recurrent prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2020-01383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No