Using PSMA PET/CT to assess lymph nodes in prostate cancer before surgery
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.
NA · University Hospital, Brest · NCT04745871
This study is testing if a new type of imaging called PSMA PET/CT can better identify lymph node involvement in men with intermediate and high-risk prostate cancer before they have surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 159 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Brest (other) |
| Locations | 1 site (Brest) |
| Trial ID | NCT04745871 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of PSMA PET/CT imaging for assessing lymph node involvement in patients with intermediate and high-risk non-metastatic prostate cancer prior to surgery. The study aims to improve the accuracy of lymph node assessment compared to conventional imaging methods, which have limitations in detecting lymph node extension. By utilizing advanced molecular imaging techniques, the trial seeks to provide better personalized treatment options for patients based on their disease status.
Who should consider this trial
Good fit: Ideal candidates include men with histologically confirmed intermediate or high-risk prostate cancer who are planning to undergo radical prostatectomy.
Not a fit: Patients with low-risk prostate cancer or those whose lymph node extension risk is below 5% may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate pre-operative assessments and improved treatment planning for prostate cancer patients.
How similar studies have performed: Other studies have shown promise in using molecular imaging for cancer assessment, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Brest
- CHRU de Brest — Brest, France (RECRUITING)
Study contacts
- Study coordinator: Philippe ROBIN
- Email: philippe.robin@chu-brest.fr
- Phone: +33298223327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer