Diagnostic Accuracy and Performance of 18F-PSMA-1007

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04986280
• Other study ID #: 2020-01383
• Status: Completed
• Start date: July 13, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: June 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: March 30, 2024
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• [18F]PSMA-1007
PSMA PET/CT using the intervention.

Locations

Country	Name	City	State
Switzerland	Inselspital, Universitätsspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	• 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
Secondary	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