Prostate cancer recurrent 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)
Conditions
Interventions
Product Name: 18F-labeled prostate-specific membrane antigen-1007
Product Code: 18F-PSMA-1007
Pharmaceutical Form: Injection
Trade Name: [18F]CHOLINE/BIOKOSMOS
Product Name: [18F] FLUOROCHOLINE
Prod
Sponsors
BIOKOSMOS S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male with original diagnosis of prostate carcinoma with prior definitive therapy 2. Suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after prostatectomy) 3. Life expectancy of 6 months or more as judged by the investigator 4. Willing and able to undergo all study procedures 5. Informed consent in writing (dated and signed) 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 114 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 76
Exclusion criteria
Exclusion criteria: 1. Age: less than18 years 2. Contraindications for F-18-Fluorocholine 3. Contraindications for any of the ingredients of F-18-PSMA-1007 4. Close affiliation with the investigational site; e.g. first-degree relative of the investigator 5. Participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial 6. Having been previously enrolled in this clinical trial 7. Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial 8. Being clinically unstable or requiring emergency treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show, in an independent assessment by 2 readers blinded to clinical data and tracer, the superiority of 18-F-PSMA-1007 over 18-F-Fluorocholine regarding the detection rate of metastatic prostate cancer lesions (patient-based analysis);Secondary Objective: 1. To compare the detection rate of the clinical investigator for F-18-PSMA-1007 and F-18- Fluorocholine for metastatic prostate cancer lesions (patient-based analysis) 2. To assess sensitivity, specificity, accuracy, positive and negative predictive value of F-18- PSMA-1007 and F-18-Fluorocholine for prostate cancer lesions (region-based analysis: prostate bed, pelvic lymph nodes, extra-pelvic lymph nodes, bone, organ metastases; reads by investigator and 3 independent blinded readers) 3. To assess the impact on diagnostic thinking, therapeutic decision making, and adequacy of therapy changes (F-18-PSMA-1007 and F-18-Fluorocholine) 4. To assess the safety profile of F-18-PSMA-1007;Primary end point(s): Detection rate of prostate cancer lesions (patient-based, independent read).;Timepoint(s) of evaluation of this end point: At the end of the two PET/CT scans | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Detection rate of prostate cancer lesions (patient-based: local investigator) 2. Per body region: sensitivity and specificity for detection of prostate cancer lesions (expert panel assessment as standard of truth) 3. Diagnostic thinking and therapeutic decisions (local investigators and independent experts) 4. Appropriateness of therapeutic decisions 5. Adverse events;Timepoint(s) of evaluation of this end point: At the end of the study | — |
Countries
Greece
Contacts
Public ContactIoannis Emmanouilidis
BIOKOSMOS S.A.
Outcome results
None listed