Diagnostic Accuracy and Performance of 18F-PSMA-1007

NCT04986280 | Completed

• 1 other identifier: 2020-01383
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

PSMA; Recurrent prostate cancer; Diagnostic accuracy; 18F-PSMA-1007; [18F]PSMA-1007

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• • To determine the patient-based detection rate of pathologic scans (sensitivity) for the new tracer

  Within one week of scan

• To explore the regional based PPV

  At one year follow up

Other Outcomes (3)

• To calculate the inter-reader reliability

  Within one month of scan

• Frequency of diagnostic pitfalls or indeterminate lesions requiring follow-up

  Within one month of scan

• Number of patients with adverse events.

  Up to 48 hours follow up post scan

Study Arms (1)

Single Arm

Arm 1 - All patients will undergo PET/CT with 18F-PSMA-1007

Diagnostic Test: [18F]PSMA-1007

Interventions

[18F]PSMA-1007 DIAGNOSTIC_TEST

PSMA PET/CT using the intervention.

Also known as: F-18-PSMA-1007

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, Universitätsspital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ali Afshar-Oromieh, MD

  Deputy Clinic Director

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: August 2, 2021
• Study Start: July 13, 2021
• Primary Completion: September 12, 2022
• Study Completion: March 30, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)