Prostate CancerNCT04986280
Diagnostic Accuracy and Performance of 18F-PSMA-1007
An observational study of Prostate Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Whereas 18F-PSMA-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. The purpose of this study is to determine the diagnostic performance for this radiotracer. 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
- How many people
- 174 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jul 2021to 30 Mar 2024
- Phase
- Observational
- 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
Study population: The data will be obtained prospectively from patients referred for routine 18F-PSMA-11 PET/CT for recurrent prostate cancer at the university clinic for nuclear medicine, Inselspital Bern. Follow up data (further imaging, laboratory parameters and details of further treatment) will be collected up to 12 months' follow up from the date of examination.
Who may be able to join
- Adult Patients referred for investigation of recurrent PC by PSMA PET/CT.
- Patients with known biochemical recurrence of a histologically confirmed primary prostate cancer, defined as:
- Post prostatectomy: two consecutive PSA > 0.2 ng/ml Post-radiotherapy: a rise of 2ng/mL > post-therapy nadir (ASTRO consensus definition)
- Male patients >18 years old
- PSA measured ± 4 weeks of the PSMA-PET/CT
- Patients willing and able to consent to the informed consent document
Who cannot join
- Patients with ADT within 6 months prior to the PSMA-PET/CT
- Inability to provide informed, written consent
- Patients undergoing active treatment for a second non-prostatic malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy and Performance of 18F-PSMA-1007 in the Detection of Recurrent Prostate Cancer - a Prospective, Single-arm Study
Whereas 18F-PSMA-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. The purpose of this study is to determine the diagnostic performance for this radiotracer.
Read the detailed description
In this prospective, single-armed diagnostic imaging study men undergoing standard-of-care PSMA PET/CT using [18F]PSMA-1007 shall be studied. The primary objective is to confirm the positive predictive value (PPV) of this tracer at a patient-based level by recruiting until 53 patients with follow-up to a composite reference standard are available. Secondary outcomes shall include patient based rate of pathological-scans stratified by PSA, the PPV stratified by region , interrelate agreement, frequency of indeterminate lesions and the safety and tolerability of the examination.
- Conditions
- Prostate Cancer
- Being tested
- [18F]PSMA-1007
- Keywords
- PSMA, Recurrent prostate cancer, Diagnostic accuracy, 18F-PSMA-1007, [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-1007Diagnostic test
Also called F-18-PSMA-1007
PSMA PET/CT using the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Arm 1 - All patients will undergo PET/CT with 18F-PSMA-1007 Receives: Diagnostic Test: [18F]PSMA-1007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective: To confirm the PPV of the new tracer (patient-based PPV)
The primary end point is the per patient PPV for the detection of PSMA-positive tumour lesions as confirmed by either a) histology or b) a composite reference standard of imaging and/or PSA fall following focal therapy in the absence of systemic therapy.
Measured: At one year follow up
Secondary outcomes (2)
• To determine the patient-based detection rate of pathologic scans (sensitivity) for the new tracer
Patient based detection (PET-positivity) rate (stratified by PSA value)
Measured: Within one week of scan
To explore the regional based PPV
Region-based PPV (prostate bed, pelvic lymph nodes, extra-pelvic lymph nodes, extra-pelvic viscera and bone metastases)
Measured: At one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start13 Jul 2021
- Primary completion12 Sep 2022
- Study completion30 Mar 2024
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.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Afshar-Oromieh, MD, Study chair, Deputy Clinic Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986280
- Sponsor's protocol ID
- 2020-01383
- Status last verified
- Jun 2024
- First submitted
- 12 Apr 2021
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy and Performance of 18F-PSMA-1007 in the Detection of Recurrent Prostate Cancer - a Prospective, Single-arm Study
- ClinicalTrials.gov ID
- NCT04986280
- Acronym / sponsor ID
- 2020-01383
- Conditions
- Prostate Cancer
- Keywords
- PSMA, Recurrent prostate cancer, Diagnostic accuracy, 18F-PSMA-1007, [18F]PSMA-1007
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 2 Aug 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.
Whereas 18F-PSMA-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. The purpose of this study is to determine the diagnostic performance for this radiotracer.
Detailed description
In this prospective, single-armed diagnostic imaging study men undergoing standard-of-care PSMA PET/CT using [18F]PSMA-1007 shall be studied. The primary objective is to confirm the positive predictive value (PPV) of this tracer at a patient-based level by recruiting until 53 patients with follow-up to a composite reference standard are available. Secondary outcomes shall include patient based rate of pathological-scans stratified by PSA, the PPV stratified by region , interrelate agreement, frequency of indeterminate lesions and the safety and tolerability of the examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | Diagnostic Test: [18F]PSMA-1007Arm 1 - All patients will undergo PET/CT with 18F-PSMA-1007 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data will be obtained prospectively from patients referred for routine 18F-PSMA-11 PET/CT for recurrent prostate cancer at the university clinic for nuclear medicine, Inselspital Bern. Follow up data (further imaging, laboratory parameters and details of further treatment) will be collected up to 12 months' follow up from the date of examination.
Key inclusion criteria (6 listed)
- Adult Patients referred for investigation of recurrent PC by PSMA PET/CT.
- Patients with known biochemical recurrence of a histologically confirmed primary prostate cancer, defined as:
- Post prostatectomy: two consecutive PSA > 0.2 ng/ml Post-radiotherapy: a rise of 2ng/mL > post-therapy nadir (ASTRO consensus definition)
- Male patients >18 years old
- PSA measured ± 4 weeks of the PSMA-PET/CT
Key exclusion criteria (3 listed)
- Patients with ADT within 6 months prior to the PSMA-PET/CT
- Inability to provide informed, written consent
- Patients undergoing active treatment for a second non-prostatic malignancy
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-1007Also: F-18-PSMA-1007PSMA PET/CT using the intervention. | Diagnostic test | Single Arm |
Primary outcome
Primary objective: To confirm the PPV of the new tracer (patient-based PPV)
Time frame: At one year follow up
The primary end point is the per patient PPV for the detection of PSMA-positive tumour lesions as confirmed by either a) histology or b) a composite reference standard of imaging and/or PSA fall following focal therapy in the absence of systemic therapy.
2 secondary outcomes
• To determine the patient-based detection rate of pathologic scans (sensitivity) for the new tracer
Time frame: Within one week of scan
To explore the regional based PPV
Time frame: At one year follow up
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 7 Jun 2024.
- Individual participant dataSharing planned: No. Upon reasonable request
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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.
Ali Afshar-Oromieh, MD study chair
Deputy Clinic Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 6 inclusion and 3 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 7 Jun 2024. 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 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.
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?
Primary objective: To confirm the PPV of the new tracer (patient-based PPV) (time frame: At one year follow up). 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 7 Jun 2024.