The use of apalutamide (Erleada) improved radiographic progression-free survival with a 52% reduction in risk of death or radiographic progression; that benefit was observed across all subgroups analyzed in the TITAN TRIAL for men with progressing prostate cancer that is still hormone sensitive. The median radiographic progression-free survival was not reached in the apalutamide group and was 22.1 months in the placebo group.
At the recent ASCO GU conference, we learned the results from the ARAMUS phase III trial which evaluated Darolutamide, an androgen receptor (AR) antagonist (a drug that prevents androgens from affecting prostate and prostate cancer cells). The trial studied the efficacy and safety of darolutamide in men with nmCRPC men.
The 10-year outcomes from the RADAR phase 3 trial were recently published. The results showed that men with locally advanced prostate cancer who were treated with six months of androgen suppression therapy (ADT) and prostatic radiotherapy did not do as well as those who were treated with 18 months of ADT and radiation.
In an analysis of the NRG Oncology clinical trial NRG-RTOG 9202 it was shown that the interval of time to biochemical reoccurrence (PSA only or BCR), or the time it takes for previously treated prostate cancer to return as indicated by a prostate-specific antigen (PSA) rise, could be used as a surrogate endpoint for survival for men with locally advanced prostate cancer.
According to Anthony V. D’Amico, MD, Ph.D., who is chief of the Division of Genitourinary Radiation Oncology and an institute physician at Dana-Farber Cancer Institute at Brigham and Women’s Hospital in Boston, “It makes logical sense that in these very aggressive prostate cancers, you need a multi-modality approach.”
PSA doubling time and the proximal PSA value are excellent predictors of the timing to the formation of metastatic prostate cancer in men who experience a biochemical recurrence (PSA only after surgery).
At the recent ASCO meeting there were two abstracts presented that discuss two potential clinical trial endpoints for survival. If they can be validated it would save research money and move FDA drug approval at a faster pace.
Two game changing trials demonstrated that the early use of Zytiga along with hormone therapy (ADT) can provide a significant survival advantage for men with aggressive, hormone naive prostate cancer. The data is very clear for men with metastatic disease, but there remains some controversy if this holds up for men who are not metastatic.