Prospective Comparative Study for Patients With Biochemical Recurrence Prostate Cancer Detecting ā¦ (NCT05622162) | Clinical Trial Compass
Active ā Not RecruitingPhase 3
Prospective Comparative Study for Patients With Biochemical Recurrence Prostate Cancer Detecting by 18F-JK-PSMA-7
Italy106 participantsStarted 2022-12-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
ā. Histological confirmation of prostate malignancy
ā. Patient must have had their primary PCa treated with surgery and/or radiation therapy; salvage radiation to the prostate bed or pelvis is allowed
ā. Patient must be ā„ 18 years of age
ā. Patient must have an Eastern Cooperative Oncology Group performance status ā¤ 2
ā. For patients treated with radical prostatectomy: arise of PSA ā„ 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 laboratory
Exclusion criteria
ā. Signed informed consent
ā. Absence of any of the inclusion criteria;
ā. More than 3 years of androgen deprivation therapy (ADT), with less than 3 months from the last treatment
ā. Spinal cord compression or impending spinal cord compression
ā. Receipt of any other investigational agents in the previous 3 months
ā. Inability to lie flat during or tolerate PET/CT
ā. Hypersensitivity to active substance or any of excipients of Investigational Medicinal Product or Comparator