Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer
Trial Parameters
Brief Summary
Prostate cancer is the third leading cause of cancer-related death in men in the United States and Europe. The treatment of metastatic castration-resistant prostate cancer (mCRPC) has evolved with the arrival of the radioligand \[177Lu\]Lu-PSMA-617, which specifically targets PSMA-expressing cancer cells. The randomized phase III VISION study showed that \[177Lu\]Lu-PSMA-617 significantly improved progression-free survival and overall survival with an acceptable toxicity profile. The ReaLuP study will evaluate the efficacy of a re-treatment of \[177Lu\]Lu-PSMA-617 in patients with progressive PSMA-positive mCRPC and who have been previously treated with \[177Lu\]Lu-PSMA without evidence of progression during this first course of treatment. Patients will be treated until disease progression, unacceptable toxicity or death, or alternatively up to 9 months after the last dose of treatment. At the end of this follow up period, patients will enter the " long term follow up ", at least for 2 years after the end of the last active follow-up.
Eligibility Criteria
Inclusion Criteria: * Males ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 assessed within 7 days of study treatment initiation * Histologically or cytologically confirmed adenocarcinoma of prostate (Patients with small cell carcinoma of the prostate may be included) * Metastatic disease documented by at least one lesion on bone scan or abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigator. Patients without bone metastasis must have measurable lesions in extra-pelvic lymph nodes or in soft-tissues as defined by RECIST 1.1 criteria * Confirmed progression mCRPC despite ongoing androgen deprivation with serum testosterone \< 50ng/dl (1.7nM) within 3 months prior to screening. Progression is defined by the presence of at least one of the following criteria : * PSA progression using local laboratory values as defined by a minimum of 2 consecutive rising PSA levels with an interval of ≥1 week b