Prospective Evaluation of 68Ga-PSMA PET-CT for Recurrence Detection of Prostate Cancer and Its Impact on Patient Management

Inclusion Criteria:

* Age ≥ 18 years old.
* Histologically-proven prostate adenocarcinoma.
* Biochemical recurrence (BCR) after local treatment with radical curative intent based on PSA values 1:

  * Following Radical Prostatectomy +/- Radiotherapy: a serum PSA increase confirmed by a second PSA measurement higher than the first one with a value of 0.2 ng/mL or more within minimum of one week.
  * Following primary Radiotherapy: PSA value of 2 ng/ml above the nadir.
  * A continued rise in PSA level despite treatment with curative intent.
* Patients with negative, inconclusive or oligometastatic disease on the Routine Imaging Workup and susceptible to be treated with curative radical intent (salvage treatment).

  * Routing Imaging Workup exams are accepted when performed within 1 month before PSMA-PET/CT (this includes WB-MRI, prostatic/pelvic MRI, and/or Bone Scintigraphy).
* Patient treatment strategy based on routine diagnostic work-up needs to be recorded after discussion at the Urologic Tumor Board and available before the PSMA PET/CT.
* ECOG performance status ≤ 2
* Signed informed consent prior to any study related procedure.

Exclusion Criteria:

* Previous malignancy other than Prostate Cancer (except basocellular or squamous cell skin cancer).
* Patients treated with palliative chemotherapy or new hormonal therapies like Abiraterone/Enzalutamide.
* PSA rise while on active treatment (LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen). A minimal time window of 1 month is required.
* Medical castration with Testosterone \< 50 ng/dl (1.7 nmol/L).
* Metastatic patients before inclusion not considered for targeted therapy.
* Previous treatment with isotopes (Radium, Samarium, Strontium, etc.)
* All medical conditions that might interfere with the correct performance of imaging scans.
* Known allergy/sensitivity to 68Ga or HBED-CC coupled substance, or any of the ingredient(s) or excipient(s) of the study medication(s)