Prostate CancerPREOP-PSMANCT04745871
Diagnostic Performance of PSMA PET/CT for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer (PREOP-PSMA ).
A study testing PSMA PET/CT in people with Prostate Cancer, run by University Hospital, Brest at 1 site in France.
Trial summary
In France, prostate cancer is the most common cancer in men over 50 years of age (nearly 50,000 new cases per year) and is the second most common cause of cancer death in men (approximately 9,000 deaths per year). 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?
- PSMA PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2021to 21 Nov 2025
- Phase
- Interventional
- 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
- Histologically confirmed prostate cancer;
- Intermediate-risk prostate cancer (PSA level of 10- 20 ng/mL and/or Clinical tumor stage ≥ T2b and/or ISUP 2 or 3, AND with risk of lymph node extension > 5% according to the Briganti nomogram) or high-risk prostate cancer (PSA ≥ 20 ng/mL and/or TR ≥ T2c and/or ISUP 4 or 5) according to d'Amico classification;
- Curative treatment by radical prostatectomy chosen by the multidisciplinary consultation meeting.
Who cannot join
- Refusal or inability to participate in the study ;
- Low-risk prostate cancer according to D'Amico's classification, or an intermediate-risk but with a risk of lymph node extension <5% according to Briganti's nomogram;
- Curative treatment other than surgical treatment chosen;
- Life expectancy < 12 months;
- Karnofsky score < 70 or ECOG score > 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer.
In France, prostate cancer is the most common cancer in men over 50 years of age (nearly 50,000 new cases per year) and is the second most common cause of cancer death in men (approximately 9,000 deaths per year). Although mortality has been declining since the end of the 1990s (about 7%/year), about 30 to 35% of them will have a biological recurrence.
Accurate assessment of local, regional and distant spread of the disease is therefore needed to design optimal personalised care for each patient, either curative or palliative.
Read more
Currently, in France, recommended disease assessment includes bone scintigraphy and Abdomino-Pelvic Magnetic Resonance Imaging. However, conventional imaging has limited performance with regard to lymph node extension.
Node dissection is the best way to assess node status. Currently, no imaging exam allows this level of accuracy.
Recently, molecular imaging has emerged as a promising tool to improve the initial extensional assessment of prostate cancer. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein, specific to the prostate, which is over-expressed on the surface of prostate cancer cells.
Recent studies of PSMA PET/CT as part of the initial extension assessment of prostate cancer report superior diagnostic performance in terms of sensitivity and specificity compared to conventional tests, as well as an impact of PSMA PET/CT on patient management.
- Conditions
- Prostate Cancer
- Being tested
- PSMA PET/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET/CTDiagnostic test
The PSMA PET/CT will be performed on an outpatient in the nuclear medicine department of the Brest University Hospital (CHRU). For this exam, the administration of 2-4 MBq/kg of 68Ga-HBED-CC-PSMA or 1,8-2,2 MBq/kg of 68Ga-PSMA-11 will be performed to patient by a single intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All patients with prostate cancer undergo PSMA PET/CT as part of the trial in addition to standard methods (abdo-pelvic MRI and a bone scan). Receives: Diagnostic Test: PSMA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of PSMA PET/CT
The main objective of the trial is to determine the diagnostic performance of Positron Emission Tomography of Prostate Specific Membrane Antigen Ligands (PET-PSMA) for the detection of lymph node metastases in intermediate- and high-risk prostate neoplasia, whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting.
Measured: Month 12
Secondary outcomes (4)
Impact of PSMA-PET in the surgical strategy of lymph node dissection.
To assess the impact of PSMA PET/CT in the surgical strategy of lymph node dissection, assessing the number of patients in whom lymph node dissection will be extended to a resectable PSMA-PET/CT suspicious area at the prostatic level.
Measured: Month 12
Comparison of prostate tumor index lesion location on PSMA PET/CT and MRI with prostate histopathology after prostatectomy.
To compare MRI and PSMA PET/CT with histopathology at the prostate level (Pathological focal uptake detected on the 3 examinations (PSMA PET/CT and MRI vs. pathology = gold standard) for each of the 6 following prostate locations: base, middle, apex (right and left)).
Measured: Month 12
Diagnostic performance of PSMA PET/CT for distant metastasis
To determine the positive predictive value of PSMA PET/CT to detect distant metastases in patients whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting.
Measured: Month 12
68Ga-HBED-CC-PSMA and et du 68Ga- PSMA-11 tolerance
The 68Ga-HBED-CC-PSMA tolerance and the et du 68Ga- PSMA-11 tolerance will be evaluated recording serious adverse events and adverse events during follow-up.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start20 May 2021
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Why it stopped: In the PREOP-PSMA protocol, written before 68Ga-PSMA-11 obtained Marketing Authorization. Today, PSMA PET/CT has become routine and is performed before MTB review.
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 University Hospital, BrestThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- TEP-PSMA
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745871
- Sponsor's protocol ID
- 29BRC20.0203
- Acronym
- PREOP-PSMA
- Status last verified
- Jun 2026
- First submitted
- 30 Nov 2020
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer.
- ClinicalTrials.gov ID
- NCT04745871
- Acronym / sponsor ID
- PREOP-PSMA / 29BRC20.0203
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In the PREOP-PSMA protocol, written before 68Ga-PSMA-11 obtained Marketing Authorization. Today, PSMA PET/CT has become routine and is performed before MTB review.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 9 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.
In France, prostate cancer is the most common cancer in men over 50 years of age (nearly 50,000 new cases per year) and is the second most common cause of cancer death in men (approximately 9,000 deaths per year). Although mortality has been declining since the end of the 1990s (about 7%/year), about 30 to 35% of them will have a biological recurrence.
Accurate assessment of local, regional and distant spread of the disease is therefore needed to design optimal personalised care for each patient, either curative or palliative.
Currently, in France, recommended disease assessment includes bone scintigraphy and Abdomino-Pelvic Magnetic Resonance Imaging. However, conventional imaging has limited performance with regard to lymph node extension.
Node dissection is the best way to assess node status. Currently, no imaging exam allows this level of accuracy.
Recently, molecular imaging has emerged as a promising tool to improve the initial extensional assessment of prostate cancer. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein, specific to the prostate, which is over-expressed on the surface of prostate cancer cells.
Recent studies of PSMA PET/CT as part of the initial extension assessment of prostate cancer report superior diagnostic performance in terms of sensitivity and specificity compared to conventional tests, as well as an impact of PSMA PET/CT on patient management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- TEP-PSMA
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: PSMA PET/CTAll patients with prostate cancer undergo PSMA PET/CT as part of the trial in addition to standard methods (abdo-pelvic MRI and a bone scan). |
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)
- Histologically confirmed prostate cancer;
- Intermediate-risk prostate cancer (PSA level of 10- 20 ng/mL and/or Clinical tumor stage ≥ T2b and/or ISUP 2 or 3, AND with risk of lymph node extension > 5% according to the Briganti nomogram) or high-risk prostate cancer (PSA ≥ 20 ng/mL and/or TR ≥ T2c and/or ISUP 4 or 5) according to d'Amico classification;
- Curative treatment by radical prostatectomy chosen by the multidisciplinary consultation meeting.
Key exclusion criteria (5 listed)
- Refusal or inability to participate in the study ;
- Low-risk prostate cancer according to D'Amico's classification, or an intermediate-risk but with a risk of lymph node extension <5% according to Briganti's nomogram;
- Curative treatment other than surgical treatment chosen;
- Life expectancy < 12 months;
- Karnofsky score < 70 or ECOG score > 2.
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 |
|---|---|---|
| PSMA PET/CTThe PSMA PET/CT will be performed on an outpatient in the nuclear medicine department of the Brest University Hospital (CHRU). For this exam, the administration of 2-4 MBq/kg of 68Ga-HBED-CC-PSMA or 1,8-2,2 MBq/kg of 68Ga-PSMA-11 will be performed to patient by a single intravenous injection. | Diagnostic test | Intervention |
Primary outcome
Diagnostic performance of PSMA PET/CT
Time frame: Month 12
The main objective of the trial is to determine the diagnostic performance of Positron Emission Tomography of Prostate Specific Membrane Antigen Ligands (PET-PSMA) for the detection of lymph node metastases in intermediate- and high-risk prostate neoplasia, whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting.
4 secondary outcomes
Impact of PSMA-PET in the surgical strategy of lymph node dissection.
Time frame: Month 12
Comparison of prostate tumor index lesion location on PSMA PET/CT and MRI with prostate histopathology after prostatectomy.
Time frame: Month 12
Diagnostic performance of PSMA PET/CT for distant metastasis
Time frame: Month 12
68Ga-HBED-CC-PSMA and et du 68Ga- PSMA-11 tolerance
Time frame: Month 12
Results and safety
The study was stopped early (reason given: In the PREOP-PSMA protocol, written before 68Ga-PSMA-11 obtained Marketing Authorization. Today, PSMA PET/CT has become routine and is performed before MTB review.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA PET/CT in people with Prostate Cancer, run by University Hospital, Brest at 1 site in France.
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 11 Jun 2026. 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 France. 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 was stopped early (reason given: In the PREOP-PSMA protocol, written before 68Ga-PSMA-11 obtained Marketing Authorization. Today, PSMA PET/CT has become routine and is performed before MTB review.). 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?
Diagnostic performance of PSMA PET/CT (time frame: Month 12). 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 11 Jun 2026.