Studying Apalutamide With ADT in High-Risk Localized Prostate Cancer

Vitaly Margulis, MD, professor of urology at UT Southwestern Medical Center, discusses the Apa-RP study (NCT04523207) of adjuvant treatment consisting of apalutamide and androgen deprivation therapy (ADT) in patients with high-risk localized prostate cancer.

Investigators sought to determine if this combination improved the biochemical recurrence (BCR)-free rate among these patients who had undergone radical prostatectomy vs prior findings from patients treated with radical prostatectomy alone.

What they found was there to be a confirmed BCR-free rate of 100% at 24 months (90% CI, 93.0-100.0), suggesting the potential of treatment intensification with 12 months of apalutamide with ADT as an option for patients with high-risk localized prostate cancer undergoing radical prostatectomy.

Transcription:

0:09 | This study addresses specifically patients with high-risk adenocarcinoma prostate after a definitive local therapy. And we know that these are mainly patients with high Gleason scores. It is a Gleason 8 or 9, and 10, high PSAs, evidence of locally advanced disease and imaging. But the point here is that 50% or more of these patients will experience disease recurrence. This is a population that is especially high-risk.

0:41 | Currently, there are no really approved adjuvant treatment options, at least systemic treatment options post surgery, for localized high-risk prostate cancers. The current standard of care in most cases will be simply observation, but yet, knowing that a significant proportion of these patients will experience disease recurrence.

1:00 | This particular trial concentrated on an end point of biochemical disease recurrence looking at 2 years. Patients in this study underwent local treatment. They had surgery and lymph node dissection for high-risk prostate cancer. And then for one year, they received ADT in the form of leuprolide, etc, plus apalutamide for 1 year, and the investigators looked at biochemical disease recurrence at 2 years. And remarkably, there were essentially no biochemical disease recurrences. So the entirety of the population remained biochemically disease recurrence free.