Diagnostic Accuracy and Performance of 18F-PSMA-1007

NCT ID: NCT04986280

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

174 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-13

Study Completion Date

2024-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Arm

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

[18F]PSMA-1007

Intervention Type DIAGNOSTIC_TEST

PSMA PET/CT using the intervention.

Interventions

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[18F]PSMA-1007

PSMA PET/CT using the intervention.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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F-18-PSMA-1007

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Afshar-Oromieh, MD

Role: STUDY_CHAIR

Deputy Clinic Director

Locations

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Inselspital, Universitätsspital Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2020-01383

Identifier Type: -

Identifier Source: org_study_id

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