A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer - PYTHO

Curium PET France0 sites217 target enrollmentApril 9, 2020

Overview

No summary available.

Registry

who.int

Start Date

April 9, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•2\. Age superior or equal to 18 years.
•3\. Histopathological proven prostate adenocarcinoma per original diagnosis.
•4\. First suspected recurrence of prostate cancer based on rising prostate\-specific antigen (PSA) after initial curative therapy with radical prostatectomy of PSA \= 0\.2 ng/mL confirmed by a subsequent PSA value of \=0\.2 ng/mL or with radiation therapy (external beam or brachytherapy) of PSA \> 2 ng/mL above the nadir after therapy regardless of the serum concentration of the nadir.
•5\. Able and willing to provide informed consent and comply with protocol requirements
•6\. Patient who can undergo all study procedures per Investigator’s point of view
•7\. Patient with social insurance cover.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 43

•1\. ECOG \> 2
•2\. History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection)
•3\. History of adjuvant radiotherapy
•4\. History of cryotherapy, high\-intensity focused ultrasound (HIFU)
•5\. Other active malignant tumour
•6\. Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or ongoing
•7\. Treatment with colchicine in the past 8 days or ongoing
•8\. Treatment with hematopoietic colony stimulating factors (CSF) in the past 5 days or ongoing
•9\. Unable to lie supine for imaging
•10\. Known allergy to investigational or reference products or to any excipients