Prospective Comparative Study for Patients With Biochemical Recurrence Prostate Cancer Detecting by 18F-JK-PSMA-7

The present study in patients with Prostate cancer and biochemical failure after surgery and/or radical-postoperative Radio Therapy (RT) will evaluate if PET/CT with 18F-JK-PSMA-7 compared to PET-CT 18F-Choline is able to identify the early pattern of biochemical recurrence and/or metastatic sites, so that the patient could be better managed, with a benefit in survival.

Inclusion Criteria:Histological confirmation of prostate malignancyPatient must have had their primary PCa treated with surgery and/or radiation therapy; salvage radiation to the prostate bed or pelvis is allowedPatient must be ≥ 18 years of agePatient must have an Eastern Cooperative Oncology Group performance status ≤ 2For patients treated with radical prostatectomy: arise of PSA ≥ 0.2 ng/mL (performed in the last month) or a rise of 2 ng/mL or more above the nadir PSA after definitive radiation therapy defined by two subsequent PSA assessments performed over a 3-month period in the same laboratoryAbsence of any of the exclusion criteriaSigned informed consentExclusion Criteria:Absence of any of the inclusion criteria;More than 3 years of androgen deprivation therapy (ADT), with less than 3 months from the last treatmentSpinal cord compression or impending spinal cord compressionReceipt of any other investigational agents in the previous 3 monthsInability to lie flat during or tolerate PET/CTHypersensitivity to active substance or any of excipients of Investigational Medicinal Product or ComparatorLife expectancy <6 monthsECOG performance status >2Refusal to sign informed consentParticipation in a concurrent clinical trialConcomitant active malignancySubject deprived of its freedom by administrative or legal decision or who is under guardianship