Prospective evaluation of 68Ga-PSMA PET-CT for Recurrence detection of Prostate Cancer and its impact on patient management The ProsPERo Trial - PROSPERO

Institut Jules Bordet0 sites75 target enrollmentJuly 4, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Males 18 years of age or older with histologically-proven prostate adenocarcinoma and biochemical relapse with rising PSA level after initial treatment with radical curative intent, not yet on palliative systemic treatment and considered for further salvage therapy
Sponsor: Institut Jules Bordet
Enrollment: 75
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

July 4, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

Institut Jules Bordet

•Age \= 18 years old.
•Histologically\-proven prostate adenocarcinoma.
•Biochemical recurrence after initial treatment with radical curative intent based on PSA values 1:
•a) Following Radical Prostatectomy (RP) \+/\- Radiotherapy (RT): 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.
•b) Following primary RT: PSA value of 2 ng/ml above the nadir.
•c) A continued rise in PSA level despite treatment with curative intent.
•Patients with negative, inconclusive or oligometastatic disease on the RIW and susceptible to be treated with curative radical intent (salvage treatment).
•RIW 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 UTB and available before the PSMA\-PET/CT.
•ECOG performance status \= 2\.

•Previous malignancy other than PCa (except basocellular or squamous cell skin cancer).
•Patients previously 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).
•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)