Ensayos clínicos

Inclusion Criteria:

• Age:  ≥ 18 years.
• Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy.
• Suspicion of recurrence or persistence.
• After radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix).
• After prostatectomy, PSA > 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association).
• For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment.
• Life expectancy of 6 months or more as judged by the investigator.
• Willing and able to undergo all study procedures.
• Informed consent in writing.

Exclusion Criteria:

• Age: less than 18 years.
• Contraindications to any of the ingredients of [18F]PSMA-1007.
• Close affiliation with the investigational site.
• 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.
• Patients who are unwilling to consider a biopsy if clinically recommended.
• Patients who are unable to undergo a PET/CT scan.
• Patients for whom systemic therapy is the most likely course regardless of PET findings.

Eligibility last updated 8/27/21. Questions regarding updates should be directed to the study team contact.