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NCT Number: NCT04986280

Diagnostic Accuracy and Performance of 18F-PSMA-1007

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Inselspital, Universitätsspital Bern

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[18F]PSMA-1007

Diagnostic Test

PSMA PET/CT using the intervention.

Other names: F-18-PSMA-1007

Primary outcomes

  1. Primary objective: To confirm the PPV of the new tracer (patient-based PPV)

    Time frame: At one year follow up

    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.

Secondary outcomes

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

    Time frame: Within one week of scan

    Patient based detection (PET-positivity) rate (stratified by PSA value)

  2. To explore the regional based PPV

    Time frame: At one year follow up

    Region-based PPV (prostate bed, pelvic lymph nodes, extra-pelvic lymph nodes, extra-pelvic viscera and bone metastases)

Other outcomes

  1. To calculate the inter-reader reliability

    Time frame: Within one month of scan

    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.

  2. Frequency of diagnostic pitfalls or indeterminate lesions requiring follow-up

    Time frame: Within one month of scan

    The frequency of indeterminate lesions requiring follow up / indeterminate lesions will be recorded by all readers and analysed by descriptive statistics

  3. Number of patients with adverse events.

    Time frame: Up to 48 hours follow up post scan

    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.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Aug 2, 2021
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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