LUNAR: A Randomized Trial of 177 Lu-PSMA Neoadjuvant Radiotherapy for Oligorecurrent Prostate Cancer

What is it about?

The LUNAR trial is a Phase 2 clinical trial that aims to determine the efficacy and safety of 177 Lu-PNT2002, a radiolabeled small molecule that binds to the prostatespecific membrane antigen (PSMA), in combination with stereotactic body radiotherapy (SBRT), versus SBRT alone, in men with oligorecurrent metastatic hormone-sensitive prostate cancer (mHSPC). The trial is randomized, stratified, and single-centered, with a 1:1 ratio between the two treatment arms. The primary endpoint is progression-free survival, and secondary endpoints include radiographic and prostate-specific antigen-based progression, acute and late physician-scored toxicity, patient-reported quality of life, ADT-free survival, time to progression, overall survival, locoregional control, and duration of response. The addition of 177 Lu-PNT2002 to metastasis-directed therapy alone may further forestall disease progression. The study was open to enrolment on 7 September 2022.

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Why is it important?

The study aims to determine the efficacy and safety of adding 177 Lu-PSMA to metastasis-directed therapy in men with oligorecurrent metastatic hormone-sensitive prostate cancer. This approach has the potential to improve treatment outcomes by further forestalling disease progression and prolonging patient survival. Key Takeaways: 1. The LUNAR trial is an open-label, randomized, two-arm, single-center Phase 2 trial comparing the efficacy and safety of neoadjuvant 177 Lu-PNT2002 plus stereotactic body radiotherapy (SBRT) to SBRT alone in men with oligorecurrent mHSPC. 2. The primary endpoint is progression-free survival, with secondary endpoints including radiographic and PSA-based progression, toxicity, quality of life, and various survival outcomes. 3. The study's design and inclusion criteria aim to partially mitigate the heterogeneity in the treated patient population, excluding patients with de novo metastatic disease and focusing on oligorecurrent disease. 4. The study's unique feature is the dose-adapted SBRT based on the response after two cycles of 177 Lu-PSMA, which may potentially decrease treatment toxicity. 5. The results of this study will provide a greater understanding of the efficacy and toxicity of 177 Lu-PSMA when combined with SBRT and may pave the way for its use in the mHSPC setting.