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.

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Prostate-Specific Membrane Antigen PET/CT
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHRU de Brest
RECRUITING
Brest
Contact Information
Primary
Philippe ROBIN
philippe.robin@chu-brest.fr
+33298223327
Time Frame
Start Date: 2021-05-20
Estimated Completion Date: 2027-05-20
Participants
Target number of participants: 159
Treatments
Experimental: Intervention
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).
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Brest

This content was sourced from clinicaltrials.gov