Suspicion of prostate cancer recurrence after previous definitive treatment, based on American Society for Radiation Oncology (ASTRO) criteria of 3 consecutive PSA rises and/or ASTRO/Phoenix criteria of PSA nadir above 2.0 ng/mL after radiotherapy or cryotherapy and/or greater than 0.2 ng/mL after prostatectomy MedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and po
Conditions
Interventions
Product Name: F-18-PSMA-1007
Pharmaceutical Form: Solution for injection
INN or Proposed INN: F-18-PSMA-1007
Current Sponsor code: F-18-PSMA-1007
Concentration unit: MBq/ml megabecquerel(s)/millilitre
Sponsors
ABX GmbH
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. 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) no F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 88
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. at the time of enrolment into this study, 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 3 readers blinded to clinical data and tracer, the superiority of F-18-PSMA-1007 over F-18-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 (regionbased 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): recurrence rate as detected by the two PET tracers (patient-based, independent read) using an expert panel as standard of truth;Timepoint(s) of evaluation of this end point: at the end of the trial, after completion of 6 months followup in all patients who complete the study | — |
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 (local investigators and independent read; expert panel assessment as standard of truth) 3. diagnostic thinking and therapeutic decisions (local investigators and expert panel) 4. appropriateness of therapeutic decisions (expert panel) 5. adverse events / safety 6. Dosimetry estamtes for F-18-PSMA-1007;Timepoint(s) of evaluation of this end point: at the end of the trial, after completion of 6 months followup in all patients who complete the study | — |
Countries
Austria, France, Switzerland
Contacts
Public ContactProject Mgt
pharmtrace klinische Entwicklung GmbH
Outcome results
None listed