EBRT + Lu-PSMA for N1M0 Prostate Cancer

Launched by THE NETHERLANDS CANCER INSTITUTE · Dec 3, 2021

Keywords

ClinConnect Summary

The EBRT + Lu-PSMA trial is studying a new treatment approach for men with a specific type of prostate cancer that has spread to nearby lymph nodes but not to other parts of the body. The goal of this study is to improve treatment effectiveness and quality of life for these patients. Currently, the standard treatment involves radiation therapy combined with hormone therapy, which can cause unwanted side effects. This trial is exploring whether adding a targeted radiation therapy called Lutetium-177-PSMA can enhance tumor control and potentially allow for a reduction or elimination of hormone therapy side effects.

To participate in this trial, men aged 18 and older with confirmed prostate cancer that meets specific criteria may be eligible. This includes having certain types of tumors and being accepted for curative treatment with radiation and hormone therapy. Participants will undergo regular check-ups and scans to monitor their health and the effectiveness of the treatment. It's important to note that those with certain health issues or previous treatments may not qualify for the study. If you're interested in learning more about this trial or think you might be eligible, please talk to your healthcare provider for guidance.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically proven prostate cancer;
• • cT2-4, partly determined by MRI;
• • N1, determined by LND/SNP and/or PSMA PET/CT;
• • iM0, determined by PSMA PET/CT;
• • Accepted for curative intent treatment with EBRT of the prostate and regional nodes + 3y ADT;
• • Visually PSMA-positive primary tumor and nodes, largest lesion ≥ average liver uptake;
• • WHO performance score 0-1;
• • Age \> 18 years;
• • For patients who have partners of childbearing potential: Willingness to use a method of birth control with adequate barrier protection during the study and for 6 months after the study drug administration; and
• • Signed written informed consen
• Exclusion Criteria:
• • Inability to comply to study procedures;
• • Inability to adhere to radiation safety measures in hospital or at home;
• • Inability to undergo the required biodistribution scans;
• • Prior or current malignant disease with potential impact on treatment outcome or survival;
• • Prior treatment with EBRT;
• • Prior treatment with ADT, already initiated \>1 month before the start of EBRT;
• • Prior treatment with radionuclide therapies, 177Lu-PSMA-617 or other;
• • Reduced bone marrow reserve (Hb\<6 mmol/L, Leukocytes\<2.5 10E9/L, or Platelets\<100 10E9/L not older than 1 month before start of EBRT);
• • Reduced renal function (GFR \< 60 not older than 1 month before start of EBRT);
• • Reduced salivary gland function (history of prior salivary gland disease); or
• • Miction problems requiring pre-treatment with ADT.