Biochemical recurrence in patients with prostate cancer after radical prostatectomy and/or radiotherapy, no CRPC status MedDRA version: 21.0 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR
Conditions
Interventions
Product Name: 68Ga-HBED-CC-PSMA
Product Code: 68Ga-PSMA
Pharmaceutical Form: Solution for injection
Sponsors
AZIENDA USL DELLA VALLE D'AOSTA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Age>45 2.Ability to provide informed written consent. All subjects must sign an informed consent form indicating their understanding investigationale nature of study 3.ECOG 0-1 4.Hystologically confirmed prostate cancer 5.Previous prostatectomy and/or radiotherapy 6.Biochemical recurrence confirmed by elevated PSA value following initial therapy (recent blood test results up to 4 weeks): - For patients status post prostatectomy, a PSA >/= 0.2 ng/ml and =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1.Inability to stay lay for the entire imaging time (e.g. cough, severe arthritis, etc) 2.Inability to complete the needed investigational due to others reasons (severe claustrophobia unresponsive to oral anxiolytics, radiation phobia, etc) 3.Patients with known CRPC status, as defined by EAU Guidelines and urologists or medical oncologists evaluation 4.Prior or concomitant chemotherapy 5.Partecipation in another clinical trial with any investigational agents within 4 weeks prior to study screening or within five half-lives of the drug 6.Patients exceeding the weight limitations of the scanner ore are not able to enter the bore of the PET scanner due to BMI 7.Other concomitant or previous malignancies, with the exception of basal cell skin tumors/superficial bladder cancer and any cancer that has been in complete remission for > 5 years. 8.Recovery from major trauma including surgery within 4 weeks prior to PET imaging 9.Presence of active infections (e.g. requiring antibimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 months;Main Objective: Sensitivity of 68Ga-PSMA PET/CT imaging in detection of recurrent prostate cancer in patient with low PSA level (<4 ng/ml);Secondary Objective: Correlation of detection rate with PSA value, primary Gleason Score and antiandrogen therapy Clinical management changes based on PET imaging findings ;Primary end point(s): Ability of 68Ga-PSMA PET/CT to identify prostate cancer recurrence in patient with low PSA level (<4 ng/ml) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Correlation of detection rate with PSA value, primary Gleason Score and antiandrogen therapy;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactS.C. Medicina Nucleare
Azienda Ospedaliera della Valle d'Aosta
Outcome results
None listed