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Completed

NCT Number: NCT04102553

F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence

This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Centre Jean Perrin Clermont-Ferrand, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male with original diagnosis of prostate carcinoma with prior definitive therapy
  • suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after prostatectomy)
  • life expectancy of 6 months or more as judged by the investigator
  • willing and able to undergo all study procedures
  • informed consent in writing (dated and signed)

Exclusion criteria

  • age: less than18 years
  • contraindications for F-18-Fluorocholine
  • contraindications for any of the ingredients of F-18-PSMA-1007
  • close affiliation with the investigational site; e.g. first-degree relative of the investigator
  • at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
  • having been previously enrolled in this clinical trial
  • mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
  • being clinically unstable or requiring emergency treatment
  • being considered a vulnerable person

Treatment and study plan

F-18-PSMA-1007

Drug

Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.

F-18-Fluorocholine

Drug

Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.

Primary outcomes

  1. To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine

    Time frame: Within 6 months after PET/CT

Sponsors and collaborators

Lead sponsor

ABX advanced biochemical compounds GmbH

Industry

Registry information

Official study title

Phase III Study of F-18-PSMA-1007 vs F-18-Fluorocholine PET to Compare the Detection Rate of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 25, 2019
Registry last updated
Jun 29, 2021

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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