Clinical Trials

Inclusion Criteria:

• Male with original diagnosis of adenocarcinoma of the prostate following definitive therapy.
• Men with Biochemical Recurrence (defined below) and planned to undergo PSMA PET imaging:
  • 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 (American Urological Association).
• 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 than 18 years.
• Variant prostate pathology including but not limited to :
  • Small cell prostate cancer;
  • Ductal prostate cancer;
  • Neuroendocrine prostate cancer.
• Prior focal therapy for prostate cancer.
• Prior neoadjuvant therapy for prosate cancer.
• Contraindications to any of the ingredients of PET.
• Close affiliation with the investigational site; e.g., first-degree relative of the investigator.
• 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 unable to undergo a PET/CT scan (e.g., patients who are extremely obese, unable to lie flat or remain still, or have uncontrollable claustrophobia).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/25/23.  Questions regarding updates should be directed to the study team contact.