Prostate Cancer MetastaticPhase 2NCT02964988
uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
A Phase 2 study testing Injection of PET tracer 68Ga-NOTA-AE105 and PET/CT in people with Prostate Cancer Metastatic and Bone Metastases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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) Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic, Bone Metastases
- What is being tested?
- Injection of PET tracer 68Ga-NOTA-AE105 and PET/CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2017to 11 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic castration resistant prostate cancer
- Approved to receive Radium-223 therapy
- Written and oral consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the detailed 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.
- Conditions
- Prostate Cancer Metastatic, Bone Metastases
- Being tested
- Injection of PET tracer 68Ga-NOTA-AE105, PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of PET tracer 68Ga-NOTA-AE105Drug
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to whole body PET/CT
PET/CTDevice
Whole body PET/CT
| Study group | Role | What they receive |
|---|---|---|
| uPAR PET/CT | Experimental | Injection of 68Ga-NOTA-AE105 followed by PET/CT scan. Administration will be performed twice in approximately 8 weeks. Receives: Drug: Injection of PET tracer 68Ga-NOTA-AE105; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour post injection
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
Measured: 8 weeks
Secondary outcomes (2)
uPAR PET/CT as prognostic factor for overall survival
Patients will be followed for 12 months after uPAR PET/CT
Measured: 12 months
uPAR PET/CT as prognostic factor for progression free survival
Patients will be followed for 12 months after uPAR PET/CT
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startJan 2017
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
Why it stopped: Recruitment issues and interim results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Øbro Fosbøl, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Marie Fosboel, MD, Principal investigator, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964988
- Sponsor's protocol ID
- AK-2016-PC-1
- Other IDs
- 2016-002184-34, 2016
- Status last verified
- Oct 2019
- First submitted
- 14 Nov 2016
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02964988
- Acronym / sponsor ID
- AK-2016-PC-1
- Conditions
- Prostate Cancer Metastatic, Bone Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues and interim results
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uPAR PET/CT | Experimental | Drug: Injection of PET tracer 68Ga-NOTA-AE105, Device: PET/CTInjection of 68Ga-NOTA-AE105 followed by PET/CT scan. Administration will be performed twice in approximately 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Metastatic castration resistant prostate cancer
- Approved to receive Radium-223 therapy
- Written and oral consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of PET tracer 68Ga-NOTA-AE105Following injection of 68Ga-NOTA-AE105 the patients will be subjected to whole body PET/CT | Drug | uPAR PET/CT |
| PET/CTWhole body PET/CT | Device | uPAR PET/CT |
Primary outcome
uPAR PET/CT imaging
Time frame: 1 hour post injection
Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105
Change in uPAR PET/CT after two cycles of Radium-223
Time frame: 8 weeks
Change in Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/CT scan performed after 2 cycles of Radium-223 therapy
2 secondary outcomes
uPAR PET/CT as prognostic factor for overall survival
Time frame: 12 months
uPAR PET/CT as prognostic factor for progression free survival
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Recruitment issues and interim results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Fosboel, MD principal investigator
Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Injection of PET tracer 68Ga-NOTA-AE105 and PET/CT in people with Prostate Cancer Metastatic and Bone Metastases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment issues and interim results). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uPAR PET/CT imaging (time frame: 1 hour post injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.