Clinical Trials Logo
  1. Home
  2. Bone Metastases
  3. NCT02964988
  4. Details
NCT02964988 Clinical Trial

uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

Bone Metastases Clinical Trial

Official title:
uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02964988
Other study ID # AK-2016-PC-1
Secondary ID 2016-002184-34
Status Terminated
Phase Phase 2
First received
Last updated
Start date January 2017
Est. completion date October 11, 2019

Study information
Verified date October 2019
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / CT molecular imaging in patients with metastatic castration-resistant prostate cancer (mCRPC)

Description:

68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/CT will be applied in patients with mCRPC during treatment with Radium-223. PET/CT will be performed before initiation of Radium therapy and after two treatment cycles. The initial semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in metastases as well as the change in these parameters after therapy will be correlated with overall survival and progression free survival.

Recruitment information / eligibility
Status Terminated
Enrollment 17
Est. completion date October 11, 2019
Est. primary completion date October 11, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Metastatic castration resistant prostate cancer

- Approved to receive Radium-223 therapy

- Written and oral consent

Exclusion Criteria:

- Lack of communication skills

- Other known malignant disease

- Known allergy towards IMP

- Severe claustrophobia

- If a participant exhibits allergic reaction i the IMP, the participant will be excluded from further participation in the study

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Injection of PET tracer 68Ga-NOTA-AE105
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to whole body PET/CT
Device:
• PET/CT
Whole body PET/CT

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary uPAR PET/CT imaging Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105 1 hour post injection
Primary Change in uPAR PET/CT after two cycles of Radium-223 Change in Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/CT scan performed after 2 cycles of Radium-223 therapy 8 weeks
Secondary uPAR PET/CT as prognostic factor for overall survival Patients will be followed for 12 months after uPAR PET/CT 12 months
Secondary uPAR PET/CT as prognostic factor for progression free survival Patients will be followed for 12 months after uPAR PET/CT 12 months
See also
  Status Clinical Trial Phase
Terminated NCT03986593 - Cryoablation of Bone Metastases From Endocrine Tumors N/A
Active, not recruiting NCT01996046 - FDG PET/CT in Breast Cancer Bone Mets
Completed NCT01358539 - Palliation: the Effect of Education on Pain Phase 3
Terminated NCT00981578 - ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain N/A
Terminated NCT00757757 - A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases Phase 1/Phase 2
Completed NCT00762346 - Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis Phase 4
Completed NCT00420433 - Bone Response in Metastatic Breast Cancer Involving Bones N/A
Completed NCT02826382 - Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041 Early Phase 1
Terminated NCT05301062 - A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
Recruiting NCT06367491 - National Database of Bone Metastases
Completed NCT03223727 - Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223
Completed NCT00830180 - Open Label Extension In Cancer Patients Phase 2
Active, not recruiting NCT03305224 - The Combination Therapy With Ra-223 and Enzalutamide Phase 2
Withdrawn NCT04109937 - External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy Trial N/A
Active, not recruiting NCT02880943 - Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL) Phase 1/Phase 2
Completed NCT01696760 - Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology N/A
Completed NCT00958477 - A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer Phase 1
Completed NCT03979118 - Exercise Prescription in Patients With Bone Metastases
Completed NCT03353090 - Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients N/A
Recruiting NCT05167669 - Pain Relief in Symptomatic Bone Metastases With Adjuvant Hyperthermia MR Guided HIFU Early Phase 1