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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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.

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

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.

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 groups in NCT02964988
Study groupRoleWhat they receive
uPAR PET/CTExperimentalInjection 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.

  1. 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

  2. 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)

  1. uPAR PET/CT as prognostic factor for overall survival

    Patients will be followed for 12 months after uPAR PET/CT

    Measured: 12 months

  2. 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.

  1. First posted16 Nov 2016 (estimated)
  2. Study startJan 2017
  3. Primary completion11 Oct 2019
  4. Study completion11 Oct 2019

Why it stopped: Recruitment issues and interim results

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT02964988.

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.

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