Phase II Randomized Study Comparing Lu-PSMA Plus Stereotactic Radiotherapy to Radiotherapy Alone for Men with Oligometastatic Prostate Cancer

What this Trial Is About

Researchers are evaluating treatments for oligometastatic prostate cancer, a condition where patients have 1 to 3 asymptomatic metastatic lesions in soft tissue or bone. This randomized phase II study aims to compare the effects of adding Lu-PSMA, a targeted radioligand therapy, to stereotactic radiotherapy versus using stereotactic radiotherapy alone. The study focuses on hormone-sensitive prostate cancer patients with metastases detected by PSMA PET-CT scans and considers recent advances in imaging and radiation therapy techniques. Participants are randomly assigned to one of two groups. One group receives ablative stereotactic radiotherapy on metastatic sites followed by two cycles of intravenous 177Lu-PSMA-I&T administered at 6-8 week intervals. The other group receives stereotactic radiotherapy alone, delivered in 1 to 5 fractions depending on lesion size and nearby tissues. This approach allows precise, high-dose radiation targeting of metastatic lesions. Treatments are tailored to individual lesion characteristics and patient condition. During the study, participants will undergo regular assessments including PSA testing to measure progression-free survival over 12 months, imaging scans for radiographic progression, and monitoring for adverse events up to 60 months. Quality of life questionnaires will also be used. Safety and overall survival will be tracked throughout the follow-up period. Participants must meet specific health and organ function criteria and use effective contraception during and after treatment. The total duration of follow-up may extend up to five years to evaluate long-term outcomes.

Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)