prostate cancer MedDRA version: 20.0 Level: LLT Classification code 10001186 Term: Adenocarcinoma of prostate System Organ Class: 100000004864
Conditions
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: COHORT 1: Men aged 45 to 75 years old with clinically-suspected PCa candidated for either initial or repeat TRUS-guided prostate biopsy; COHORT 2: Men consenting to enter the PRIAS MRI side-study COHORT 3a: Male with cyto/histological confirmation of high risk PCa, willing to undergo radical prostatectomy and pelvic lymph node dissection. COHORT 3b: Male with cyto/histological confirmation of PCa, willing to undergo nerve-sparing radical prostatectomy Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 186
Exclusion criteria
Exclusion criteria: 1. Hormone androgen deprivation therapy of any type within 6 months prior to enrollment. 2. Prior pelvic radiotherapy; 3. Sickle cell disease; 4. Insufficient renal function (eGFR < 30 mL/min/1.73 m2); 5. Hip prosthesis, vascular grafting or other conditions affecting imaging; 6. Contraindication to MRI; 7. History of allergic reactions attributed to compounds of similar chemical or biologic com-position to 68Ga-PSMA or Gadolinium-based contrast agents used in the study. 8. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: COHORTS 1 and 2: TO ASSESS THE SEPARATE DIAGNOSTIC ACCURACY OF 68GA-PSMA PET/CT AND MP-3TMRI FOR IMAGING-GUIDED DIAGNOSIS / EXCLUSION OF CLINICALLY-SIGNIFICANT PCA. COHORT 3a: To characterize the detection rate and intra-prostatic localization of primary CS-PC foci by separate pelvic mp-3TMRI, whole-body 68Ga-PSMAHBED PET/CT and comparing to pathology outcomes in men with biopsy-proven PCa. COHORT 3b: to characterize the staging accuracy of pelvic mp-3TMRI in the pre-surgical work-up of PCa patients who are candidates for nerve-sparing surgery (NSS);Secondary Objective: COHORTS 1 and 2: Safety / Toxicity of BIOPSTAGE interventional imaging procedures, namely 68Ga-PSMA ad-ministration (the PET tracer) and Gadoteric Acid (the MRI contrast agent) and of BIOPSTAGE TRUS-guided prostate biopsies sessions. COHORT 3a: - To determine separate diagnostic accuracy of 68Ga-PSMA PET/CT and mp-3TMRI for detecting and localizing N1 disease (lesion-based analysis); - Safety / Toxicity profile of 68Ga-PSMA administration (PET radiopharmaceutical) and of Gadoteric Acid / Dotarem administration (MRI contrast agent). COHORT 3b: - mp-3TMRI-based feasibility of mono-/bi-lateral nerve-sparing expressed as the concordance between the feasibility of nerve-sparing approach between mp-3TMRI and surgical evidence; - Safety / Toxicity profile of Gadoteric Acid / Dotarem administration (MRI contrast agent) ;Primary end point(s): COHORTS 1 and 2: •68Ga-PSMA PET/CT Sensitivity, Specificity, Positive Predictive Value; Negative Predic-tive Value, Diagnostic Accuracy for clinically-significant PCa (lesion-based and 12-prostate region-based analysis); •mp-3TMRI Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Diagnostic Accuracy for clinically-significant PCa (lesion-based and | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): COHORT 3b: Safety / Toxicity profile of Gadoteric Acid / Dotarem administration (MRI contrast agent).;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Italy
Contacts
Public ContactCentro di Coordinamento Studi IRST
IRST IRCCS
Outcome results
None listed