RecruitingNot ApplicableNCT04745871

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

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.


Sponsor

University Hospital, Brest

Enrollment

159 participants

Start Date

May 20, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether a specialized PET/CT scan using a PSMA tracer (which targets prostate-specific membrane antigen) can more accurately identify lymph node spread before surgery in men with intermediate or high-risk prostate cancer. **You may be eligible if...** - You have a biopsy-confirmed prostate cancer - Your cancer is classified as intermediate risk (PSA 10–20, stage T2b or higher, or Gleason/ISUP grade 2–3) or high risk (PSA ≥20, stage T2c or higher, or ISUP grade 4–5) - Your multidisciplinary team has recommended radical prostatectomy (surgical removal) as your treatment - Your risk of lymph node spread is greater than 5% based on standard predictive tools **You may NOT be eligible if...** - You are being treated with radiation rather than surgery - Your cancer is low-risk - You have already started hormone therapy - You have prior pelvic lymph node surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPSMA PET/CT

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.


Locations(1)

CHRU de Brest

Brest, France

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NCT04745871


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