Prostate CancerPhase 3NCT06122584
Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer
A Phase 3 study testing [18F]PSMA-1007 in people with Prostate Cancer, run by ABX advanced biochemical compounds GmbH at 19 sites in 6 countries.
Trial summary
This study assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- [18F]PSMA-1007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 19 sitesin 6 countries
- Study dates
- 13 Jun 2024to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- The patient (male) is aged 18 years or above.
- The patient is able to understand the information presented to him concerning the nature, scope, and consequences of the trial as set out in the information provided to the patient AND has provided written informed consent to participate.
- The patient has newly diagnosed, biopsy-proven, clinically localized prostate adenocarcinoma, and curative prostatectomy with extended pelvic lymph node dissection is his preferred course of treatment.
- The patient has at least high-risk disease as defined by the NCCN guidelines (version 1.2023). That is, the presence of any one or more of the following:
- Overall ISUP grade group 4 or 5,
- Clinical category T3a or greater,
- Serum PSA level greater than 20 ng/ml.
- The patient has undergone conventional imaging (CT or MRI, and bone scan if clinically indicated) to detect the presence of pelvic nodal involvement and bone or visceral metastases within 60 days of the planned PET-CT procedure.
Who cannot join
- Patients for whom radical prostatectomy is not clinically appropriate or the patient is otherwise unlikely to undergo radical prostatectomy with extensive pelvic lymph node dissection.
- The patient has received any therapy - be it radiation, surgical or drug therapy - for his prostate cancer.
- The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of [18F]PSMA-1007.
- The patient is not able to have PET-CT scans (for example, because of weight, claustrophobia, or inability to lie still for the duration of the scan).
- The patient is closely affiliated to the investigation site; e.g. is a first-degree relative of the investigator.
- At the time of screening, the patient is receiving any other investigational agent(s), or he has received any such agent(s) within the previous 30 days, or he is scheduled to receive any such agent(s) in the period up to the planned date for the last study visit.
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- The patient has previously been enrolled in this trial.
- The patient has previously undergone PET imaging with any PSMA-avid product.
- The patient has histological evidence of small-cell carcinoma of the prostate.
- The patient is clinically unstable or requires emergency treatment.
- The patient has any mental condition rendering him incapable of understanding the nature, scope, and consequences of the trial as set out in the information given to the patient.
Trial locations and contacts
19 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 6 countries
Germany8 sites, 7 recruiting
- Recruiting
Carl Gustav Carus Faculty of Medicine, TUD Dresden
Dresden
- Recruiting
University Hospital Düsseldorf
Düsseldorf
- Recruiting
St. Antonius Hospital
Gronau
- Recruiting
University Hospital Hamburg-Eppendorf
Hamburg
- Recruiting
University Hospital Leipzig
Leipzig
- Completed
Klinikum rechts der Isar, TUM
München
- Recruiting
University Hospital Münster
Münster
- Recruiting
Universitätsmedizin Rostock
Rostock
Japan3 sites, 3 recruiting
- Recruiting
The University of Osaka Hospital
Osaka
- Recruiting
Jikei University Hospital
Tokyo
- Recruiting
National Cancer Center
Tokyo
Spain3 sites, 1 recruiting
- Recruiting
Hospital Del Mar
Barcelona
- Active, not recruiting
Hospital Vall d'Hebron
Barcelona
- Active, not recruiting
Hospital Vithas Valencia 9 de Octubre
Valencia
Italy2 sites, 1 recruiting
- Completed
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
Meldola
- Recruiting
IRCCS Ospedale Sacro Cuore-Don Calabria
Verona
Netherlands2 sites, 2 recruiting
- Recruiting
CWZ
Nijmegen
- Recruiting
Radboud UMC
Nijmegen
About this study
Official title: Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer
This study assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer
- Conditions
- Prostate Cancer
- Being tested
- [18F]PSMA-1007
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]PSMA-1007Drug
Diagnostic radiopharmaceutical for PET scan
| Study group | Role | What they receive |
|---|---|---|
| [18F]PSMA-1007 | Experimental | Single intravenous administration of [18F]PSMA-1007 for Positron Emission Tomography (PET) scan Receives: Drug: [18F]PSMA-1007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of [18F]PSMA-1007 PET/CT for the detection of pelvic nodal disease (N1) compared to histology as the standard of reference
Measured: 6 to 8 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start13 Jun 2024
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ABX advanced biochemical compounds GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122584
- Sponsor's protocol ID
- EAGLE-i
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT06122584
- Acronym / sponsor ID
- EAGLE-i
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- ABX advanced biochemical compounds GmbHIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Nov 2023 (actual)
- 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.
This study assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]PSMA-1007 | Experimental | Drug: [18F]PSMA-1007Single intravenous administration of [18F]PSMA-1007 for Positron Emission Tomography (PET) scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient (male) is aged 18 years or above.
- The patient is able to understand the information presented to him concerning the nature, scope, and consequences of the trial as set out in the information provided to the patient AND has provided written informed consent to participate.
- The patient has newly diagnosed, biopsy-proven, clinically localized prostate adenocarcinoma, and curative prostatectomy with extended pelvic lymph node dissection is his preferred course of treatment.
- The patient has at least high-risk disease as defined by the NCCN guidelines (version 1.2023). That is, the presence of any one or more of the following:
- The patient has undergone conventional imaging (CT or MRI, and bone scan if clinically indicated) to detect the presence of pelvic nodal involvement and bone or visceral metastases within 60 days of the planned PET-CT procedure.
Key exclusion criteria (11 listed)
- Patients for whom radical prostatectomy is not clinically appropriate or the patient is otherwise unlikely to undergo radical prostatectomy with extensive pelvic lymph node dissection.
- The patient has received any therapy - be it radiation, surgical or drug therapy - for his prostate cancer.
- The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of [18F]PSMA-1007.
- The patient is not able to have PET-CT scans (for example, because of weight, claustrophobia, or inability to lie still for the duration of the scan).
- The patient is closely affiliated to the investigation site; e.g. is a first-degree relative of the investigator.
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 |
|---|---|---|
| [18F]PSMA-1007Diagnostic radiopharmaceutical for PET scan | Drug | [18F]PSMA-1007 |
Primary outcome
Sensitivity and specificity of [18F]PSMA-1007 PET/CT for the detection of pelvic nodal disease (N1) compared to histology as the standard of reference
Time frame: 6 to 8 weeks post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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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.
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [18F]PSMA-1007 in people with Prostate Cancer, run by ABX advanced biochemical compounds GmbH at 19 sites in 6 countries.
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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Japan, Spain, Italy, Netherlands and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Hoepping, Dr. (+49 3528 4041 60, cd@abx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of [18F]PSMA-1007 PET/CT for the detection of pelvic nodal disease (N1) compared to histology as the standard of reference (time frame: 6 to 8 weeks post-surgery). 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 4 Nov 2026.