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

Phase 1

• 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; MedDRA version: 19.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10068979Term: Imaging procedureSystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2016-000842-79-BE
• Lead Sponsor: Institut Jules Bordet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-04
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 75

Inclusion Criteria

•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.
•Signed informed consent prior to any study related procedure.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

•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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified