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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Richard Pougnet

    Brest, 29609

Other trials in France

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 .

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.

  1. 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)
  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.

  1. First posted30 Jul 2021
  2. Study start1 Oct 2018
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

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)
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

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.

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