Phase II trial: uPAR-PET/CT in prostate cancer patients treated with Radium-223-dichloride
Phase 1
- Conditions
- Metastatic castration resistant prostate cancerMedDRA version: 19.0Level: PTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2016-002184-34-DK
- Lead Sponsor
- Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 43
Inclusion Criteria
- Metastatic castration resistant prostate cancer
- Approved to receive Radium-223 therapy
- Age = 18 years
- Written and oral consent
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33
Exclusion Criteria
- Lack of communication skills, including inability to understand study protocol
- Other known malignant disease
- Severe claustrophobia
- Known allergy towards the IMP
- If a participant exhibits allergic reaction to the IMP, the participant will be excluded from further participation in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Investigate 68Ga-NOTA-AE105 PET/CT for response evaluation of Radium-223 therapy in patients with metastatic castration resistant prostate cancer.<br><br>;Secondary Objective: Investigate 68Ga-NOTA-AE105 PET/CT for prognostication in patients with metastatic castration resistant prostate cancer treated with Radium-223 therapy;Primary end point(s): Uptake of 68Ga-NOTA-AE105 in prostate cancer metastases in bone and soft tissue quantified as SUVmax and SUVmean (standardized uptake value) before treatment with Radium-223 and after two series of treatment.;Timepoint(s) of evaluation of this end point: End point is evaluated from PET/CT scans performed within one hour post injection of 68Ga-NOTA-AE105
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Overall survival (defined as time from first dose of Radium therapy to death of any cause)<br>- Time to progression: Time from first dose of Radium therapy to progression defined as development of soft tissue metastases, generel deterioration (WHO performance score > 2) or progression of bone metastases (defined as increased skeletal involvement radiologically or occurrence of symptomatic skeletal-related event (defined as occurrence of new pathological fracture or spinal cord compression or lesion progression requiring external beam radiation therapy or surgical intervention);Timepoint(s) of evaluation of this end point: End poins are evaluated by clinical follow-up 12 months after inclusion of the last participant<br>