Spots Global Cancer Trial Database for Safety of Prodencel in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC)

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Trial Identification

Brief Title: Safety of Prodencel in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC)

Official Title: A Multicenter, Non-randomized, Open-label, and Dose-escalation Phase I Study to Evaluate the Safety of Prodencel Treatment in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Study ID: NCT05533203

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

Prodencel; an autologous dendritic cell therapeutic tumor vaccine

Study Description

Brief Summary: This phase I clinical trial is to evaluate the safety of Prodencel (an autologous dendritic cell therapeutic tumor vaccine.) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Detailed Description: This is a single arm pilot study to evaluate the safety of delivering a dendritic cell vaccine in fifteen to twenty-four (n=15-24) adult patients diagnosed with prostate adenocarcinoma after novel androgen-deprived therapy and docetaxel chemotherapy failure. The study is constructed in a 3+3 design for three steps of dose escalation with rigorous and mandatory safety monitoring. Subjects received the vaccine at a dose of 5-15×10\^6 cells every two weeks for a total of 3 doses. A dose from cohort 1-3 is recommended for booster immunization every 4 weeks until disease progression or intolerance, to evaluate the safety and tolerability of the booster immunization of Prodencel. Subjects will be monitored for adverse events as dictated by CTCAE version 5.