Phase II trial: uPAR-PET/CT in prostate cancer patients treated with Radium-223-dichloride

Phase II trial: uPAR-PET/CT in Radium-223-dichloride treatment of patients with metastatic castration-resistant prostate cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002184-34-DK

Enrollment

Registered

2016-08-17

Start date

2016-09-14

Completion date

Unknown

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic castration resistant prostate cancer MedDRA version: 19.0 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: 68Ga-NOTA-AE105 Product Code: 68Ga-NOTA-AE105 Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN: 68Ga-NOTA-AE105 Current Sponsor code: 68Ga-NOTA

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate 68Ga-NOTA-AE105 PET/CT for response evaluation of Radium-223 therapy in patients with metastatic castration resistant prostate cancer. ;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	—

Measure

Time frame

Main Objective: Investigate 68Ga-NOTA-AE105 PET/CT for response evaluation of Radium-223 therapy in patients with metastatic castration resistant prostate cancer. ;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

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Secondary

Measure	Time frame
Secondary end point(s): - Overall survival (defined as time from first dose of Radium therapy to death of any cause) - 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	—

Measure

Time frame

Secondary end point(s): - Overall survival (defined as time from first dose of Radium therapy to death of any cause) - 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

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Countries

Denmark

Contacts

Public ContactMarie Øbro Fosbøl

Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET

marie.oebro.fosboel@regionh.dk004531508808

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026