Prostatic NeoplasmsRB-PSMANCT04983459
PSMA PET/CT for Biochemical Recurrence Detection in Patients With Prostate Cancer
An observational study of Prostatic Neoplasms and Recurrence, run by University Hospital, Brest at 1 site in France.
Trial summary
The aim of this study is to evaluate PSMA-PET for the detection of occult biological recurrence in patients with prostatic cancer referred to the Brest University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Neoplasms, Recurrence
- How many people
- 205 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2018to 31 Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred to the nuclear medicine department of Brest University Hospital for a biological recurrence of a prostatic cancer.
Who may be able to join
- Patients aged 18 years old or older
- Patients referred for a PSMA PET/CT for biochemical recurrence in the nuclear medicine department of Brest University Hospital
Who cannot join
- Patients for whom PET-PSMA was performed for other reasons.
- Patient's refusal to have their data used for clinical research purposes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positron Emission Tomography/Computed Tomography With Prostate Specific Membrane Antigen Ligands for Occult Biochemical Recurrence Detection in Patients With Prostate Cancer: a Single Centre Experience
The aim of this study is to evaluate PSMA-PET for the detection of occult biological recurrence in patients with prostatic cancer referred to the Brest University Hospital.
Read the detailed description
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 third leading cause of cancer-related death in men (approximately 9,000 deaths per year).
Among patients who have undergone a curative treatment strategy for localized prostate cancer, between 27% and 53% of them will have a biochemical recurrence within 10 years.
Biochemical recurrence is defined as :
- After total prostatectomy by the persistence of a detectable PSA or the reappearance of a detectable PSA above 0.2 ng/ml after a more or less long period of undetectability.
- After conservative treatment (radiotherapy or brachytherapy) by an increase in PSA above a threshold set at nadir +2 ng/ml Biological recurrence precedes the occurrence of symptomatic metastases by an average of 7-8 years.
Currently, after prostatectomy, when the PSA is < 1 ng/mL, no imaging test is recommended for the assessment of recurrence (grade A recommendation).
The sensitivity of currently available tests does not provide sufficiently discriminating information for this PSA value.
Multiparametric MRI performs well in detecting local recurrence, particularly in the case of PSA > 1 ng/mL (sensitivity of 98%, specificity of 94% for the detection of 5 mm lesions).
18F-choline positron emission tomography (PET-choline) is of interest in the detection of distant lymph node and/or visceral recurrences; indeed, PET-choline has proven its superiority in detection compared with conventional examinations, particularly for PSA values above 2ng/ml with a detection rate of up to 90%.
However, the performance of this examination remains dependent on the PSA level and is low when the PSA level is below 1 ng/ml (sensitivity around 5-24% for a PSA below 1 ng/ml).
The performance of PET-choline is optimised for low PSA by taking into account the PSA doubling time and velocity.
Recently, prostate specific membrane antigen ligand positron emission tomography (PET-PSMA) has emerged as the most promising new molecular imaging modality for the management of prostate cancer.
Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein selectively overexpressed in 90-100% of prostate cancer lesions, as well as in metastatic lymph nodes and bone metastases, making it an ideal target for molecular imaging of prostate cancer.
This tracer appears to perform better than other imaging modalities, particularly for low PSA values, with a detection rate of 50% for a PSA level below 0.5 ng/ml compared to 5-20% with PET-choline. Indeed, a 2019 meta-analysis evaluating the value of PSMA-PET in patients with biologic recurrence of prostate adenocarcinoma reported detection rates of 45%, 59%, 75% and 95% for PSA levels < 0.5 ng/mL, between 0.5 and 0.9 ng/mL, between 1 and 1.9 ng/mL and 2 ng/mL respectively.
The aim of this study is to evaluate PSMA ligand PET for the detection of occult biological recurrence in patients with prostatic neoplasia referred to the Brest University Hospital .
- Conditions
- Prostatic Neoplasms, Recurrence
- Keywords
- PSMA PET/CT
- Medical subject headings
- Prostatic Neoplasms, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate per patient of PET-PSMA for the detection of biochemical recurrence.
To evaluate the detection rate per patient of PET-PSMA for the detection of biochemical recurrence
Measured: 12 months
Secondary outcomes (1)
Detection rate per region of PSMA-PET for the detection of biochemical recurrence
To assess the detection rate per region (prostatic bed, pelvic lymph node, extra pelvic lymph node and distant of PSMA-PET for the detection of biochemical recurrence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Oct 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 205 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
- NCT04983459
- Sponsor's protocol ID
- RB-PSMA (29BRC21.0040)
- Acronym
- RB-PSMA
- Status last verified
- Jul 2021
- First submitted
- 17 Jun 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography/Computed Tomography With Prostate Specific Membrane Antigen Ligands for Occult Biochemical Recurrence Detection in Patients With Prostate Cancer: a Single Centre Experience
- ClinicalTrials.gov ID
- NCT04983459
- Acronym / sponsor ID
- RB-PSMA / RB-PSMA (29BRC21.0040)
- Conditions
- Prostatic Neoplasms, Recurrence
- Keywords
- PSMA PET/CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 30 Jul 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.
The aim of this study is to evaluate PSMA-PET for the detection of occult biological recurrence in patients with prostatic cancer referred to the Brest University Hospital.
Detailed description
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 third leading cause of cancer-related death in men (approximately 9,000 deaths per year).
Among patients who have undergone a curative treatment strategy for localized prostate cancer, between 27% and 53% of them will have a biochemical recurrence within 10 years.
Biochemical recurrence is defined as :
- After total prostatectomy by the persistence of a detectable PSA or the reappearance of a detectable PSA above 0.2 ng/ml after a more or less long period of undetectability.
- After conservative treatment (radiotherapy or brachytherapy) by an increase in PSA above a threshold set at nadir +2 ng/ml Biological recurrence precedes the occurrence of symptomatic metastases by an average of 7-8 years.
Currently, after prostatectomy, when the PSA is < 1 ng/mL, no imaging test is recommended for the assessment of recurrence (grade A recommendation).
The sensitivity of currently available tests does not provide sufficiently discriminating information for this PSA value.
Multiparametric MRI performs well in detecting local recurrence, particularly in the case of PSA > 1 ng/mL (sensitivity of 98%, specificity of 94% for the detection of 5 mm lesions).
18F-choline positron emission tomography (PET-choline) is of interest in the detection of distant lymph node and/or visceral recurrences; indeed, PET-choline has proven its superiority in detection compared with conventional examinations, particularly for PSA values above 2ng/ml with a detection rate of up to 90%.
However, the performance of this examination remains dependent on the PSA level and is low when the PSA level is below 1 ng/ml (sensitivity around 5-24% for a PSA below 1 ng/ml).
The performance of PET-choline is optimised for low PSA by taking into account the PSA doubling time and velocity.
Recently, prostate specific membrane antigen ligand positron emission tomography (PET-PSMA) has emerged as the most promising new molecular imaging modality for the management of prostate cancer.
Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein selectively overexpressed in 90-100% of prostate cancer lesions, as well as in metastatic lymph nodes and bone metastases, making it an ideal target for molecular imaging of prostate cancer.
This tracer appears to perform better than other imaging modalities, particularly for low PSA values, with a detection rate of 50% for a PSA level below 0.5 ng/ml compared to 5-20% with PET-choline. Indeed, a 2019 meta-analysis evaluating the value of PSMA-PET in patients with biologic recurrence of prostate adenocarcinoma reported detection rates of 45%, 59%, 75% and 95% for PSA levels < 0.5 ng/mL, between 0.5 and 0.9 ng/mL, between 1 and 1.9 ng/mL and 2 ng/mL respectively.
The aim of this study is to evaluate PSMA ligand PET for the detection of occult biological recurrence in patients with prostatic neoplasia referred to the Brest University Hospital .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the nuclear medicine department of Brest University Hospital for a biological recurrence of a prostatic cancer.
Key inclusion criteria (2 listed)
- Patients aged 18 years old or older
- Patients referred for a PSMA PET/CT for biochemical recurrence in the nuclear medicine department of Brest University Hospital
Key exclusion criteria (2 listed)
- Patients for whom PET-PSMA was performed for other reasons.
- Patient's refusal to have their data used for clinical research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection rate per patient of PET-PSMA for the detection of biochemical recurrence.
Time frame: 12 months
To evaluate the detection rate per patient of PET-PSMA for the detection of biochemical recurrence
1 secondary outcome
Detection rate per region of PSMA-PET for the detection of biochemical recurrence
Time frame: 12 months
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 30 Jul 2021.
- 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?
An observational study of Prostatic Neoplasms and Recurrence, 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 2 inclusion and 2 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 30 Jul 2021. 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 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?
Detection rate per patient of PET-PSMA for the detection of biochemical recurrence. (time frame: 12 months). 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 30 Jul 2021.