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

• Status: Withdrawn
• Trial end date: 2017-01-20
• Target enrollment: 0
• Participant gender: Male

Summary

Single arm, phase II exploratory trial to prospectively evaluate the impact of 68Ga-PSMA-PET/CT on the therapeutic management of patients with biological recurrent prostate cancer and negative, equivocal or oligometastatic disease after routine imaging diagnostic work-up.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jules Bordet Institute
• Treatments: Edetic Acid; Gallium 68 PSMA-11

Criteria

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)