96 patients are expected to participate in the PROter trial which is an open label, multi-center, dose escalation expansion trial evaluating treatment with 177Lu-Psma-R2 RadioLigand Therapy in patients with PSMA positive progressive metastatic castration resistant prostate cancer following previous systemic treatment. Phase I objectives included characterizing drug safety profile and tolerability, and identifying dosage for Phase II dose trials. Phase II primary objective is assessing antitumor activity measured by radiographic progression free survival, prostate specific antigen response, time to PSA progression and survival.
30 patients are expected to participate in the PROfind trial which will evaluate positron emission tomography imaging with 68Ga-PSMA-R2 in patients with biochemical relapse and metastatic prostate cancer to assess safety and tolerability of administration of 68Ga-PSMA-R2, and evaluate pharmacokinetics, biodistribution and dosimetry of 68Ga-PSMA-R2.
Prostate cancer is the second most common type of cancer worldwide among male populations leading to substantial morbidity and mortality, representing the second most common cause of cancer death in the male population within the USA and third most common cause of death in developed countries. Prostate cancer can be curable if found and diagnosed at an early stage. 40% of patients with prostate cancer develop biochemical relapse within 10 years after initial local treatment and some patients progress to metastatic prostate cancer; patients living long enough eventually succumb to metastatic castration resistant prostate cancer.
