Diagnostic Performance of PSMA PET/CT for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer (PREOP-PSMA ).

NCT04745871 | Recruiting DMC

• 1 other identifier: 29BRC20.0203
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 12

Secondary Outcomes (4)

• Impact of PSMA-PET in the surgical strategy of lymph node dissection.

  Month 12

• Comparison of prostate tumor index lesion location on PSMA PET/CT and MRI with prostate histopathology after prostatectomy.

  Month 12

• Diagnostic performance of PSMA PET/CT for distant metastasis

  Month 12

• 68Ga-HBED-CC-PSMA and et du 68Ga- PSMA-11 tolerance

  Month 12

Study Arms (1)

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).

Diagnostic Test: PSMA PET/CT

Interventions

PSMA PET/CT DIAGNOSTIC_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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Philippe ROBIN

CONTACT

+33298223327; philippe.robin@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: TEP-PSMA

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: February 9, 2021
• Study Start: May 20, 2021
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)