This phase 2 trial is examining the effectiveness and safety of sacituzumab govitecan (IMMU-132)in patients with metastatic castration-resistant prostate cancer (mCRPC) who are having cancer progression on abiraterone (Zytiga) or enzalutamide (Xtandi). The main outcome to be measured will be the PSA (a protein in the blood that rises in prostate cancer) response rate. This trial is recruiting in New York and Wisconsin, US.
A treatment option for patients with mCRPC (the cancer is able to grow and continue to spread despite using hormone therapy) is with abirateroneor enzalutamide. They both work to inhibit male sex hormones. This helps stop the tumor from growing and spreading. For patients who are progressing on this treatment, newer drugs are being developed. One such option is sacituzumab govitecan (a type of immunotherapy which may induce changes in the body’s immune system and may interfere with the ability of tumor cells to grow and spread).
This study is being done to investigate the effectiveness and safety of sacituzumab govitecan in patients with mCRPC who are having cancer progression on abiraterone or enzalutamide. The main outcome to be measured will be the PSA response rate at 9 weeks follow-up.
Who are they looking for?
55 participants with mCRPC will be recruited. Patients must have a biopsy to confirm adenocarcinoma of the prostate, confirmed metastases (tumors outside the prostate), have disease progression, have normal organ function, and be on effective birth control.
Patients cannot participate if they have had previous chemotherapy for CRPC or radiotherapy within 4 weeks of starting the trial. They cannot be on any herbal products, have active brain metastases, other invasive cancer, heart problems, diabetes mellitus acute complications, previous strokes, active HIV, or hepatitis B or C.
How will it work
There will be only one group. All patients will receive sacituzumab govitecan on day 1 and day 8 of a 21-day cycle, for a minimum of 3 cycles.