Prostate CancerPhase 3NCT04742361
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
A Phase 3 study testing [18F]PSMA-1007 in people with Prostate Cancer and Prostate Cancer Recurrent, run by ABX advanced biochemical compounds GmbH at 6 sites in 3 countries.
Trial summary
This study evaluates the diagnostic performance and safety of [18F]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Recurrent
- 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
- 136 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 27 Aug 2021to 5 May 2025
- Phase
- Phase 3
- 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
- Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy
- Suspicion of recurrence or persistence
- after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)
- after prostatectomy, PSA > 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association)
- For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment.
- Life expectancy of 6 months or more as judged by the investigator
- Willing and able to undergo all study procedures
- Informed consent in writing
Who cannot join
- Age: less than18 years
- Contraindications to any of the ingredients of [18F]PSMA-1007
- Close affiliation with the investigational site
- At the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
- Having been previously enrolled in this clinical trial
- Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
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- Being clinically unstable or requiring emergency treatment
- Patients who are unwilling to consider a biopsy if clinically recommended
- Patients who are unable to undergo a PET/CT scan
- Patients for whom systemic therapy is the most likely course regardless of PET findings.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, 77042
Mayo Clinic
Rochester, Minnesota, 55905
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: Phase III Study of [18F]PSMA-1007 Positron Emission Tomography for the Detection of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer
This study evaluates the diagnostic performance and safety of [18F]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.
- Conditions
- Prostate Cancer, Prostate Cancer Recurrent
- 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.
Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT)
Measured: Within 6 months after PET/CT
Patient-level correct detection rate of [18F]PSMA-1007
Measured: Within 6 months after PET/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start27 Aug 2021
- Primary completion23 Jun 2023
- Study completion5 May 2025
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
- 136 participants (actual)
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
- NCT04742361
- Sponsor's protocol ID
- ABX-CT-303
- Status last verified
- Jul 2025
- First submitted
- 3 Feb 2021
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of [18F]PSMA-1007 Positron Emission Tomography for the Detection of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT04742361
- Acronym / sponsor ID
- ABX-CT-303
- Conditions
- Prostate Cancer, Prostate Cancer Recurrent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- ABX advanced biochemical compounds GmbHIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 8 Feb 2021 (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 evaluates the diagnostic performance and safety of [18F]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.
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)
- Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy
- Suspicion of recurrence or persistence
- For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment.
- Life expectancy of 6 months or more as judged by the investigator
- Willing and able to undergo all study procedures
Key exclusion criteria (10 listed)
- Age: less than18 years
- Contraindications to any of the ingredients of [18F]PSMA-1007
- Close affiliation with the investigational site
- At the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
- Having been previously enrolled in this clinical trial
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
Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT)
Time frame: Within 6 months after PET/CT
Patient-level correct detection rate of [18F]PSMA-1007
Time frame: Within 6 months after PET/CT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 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 and Prostate Cancer Recurrent, run by ABX advanced biochemical compounds GmbH at 6 sites in 3 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 10 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: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Netherlands, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT) (time frame: Within 6 months after PET/CT). 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 Jul 2025.