Neoadjuvant hormone therapy beneficial for patients with high-risk prostate cancer: Study
Intense neoadjuvant hormone therapy in patients with high-risk prostate cancer shows favorable pathologic responses, suggested a study published in The Journal of Urology.
A multicenter randomized phase 2 trial was conducted by McKay R et. al to investigate the influence of intense androgen deprivation on radical prostatectomy pathologic response and radiographic and tissue biomarkers in localized prostate cancer.
The researchers selected eligible patients with a Gleason score of ≥4+3=7, prostate-specific antigen >20 ng/mL or T3 disease and lymph nodes <20 mm.
The researchers recruited a total of 118 patients at 4 sites.
With the median age of 61 years, 94% of patients showed high-risk disease.
In Part 1, patients were randomized in the ratio of 1:1 to apalutamide, abiraterone acetate, prednisone, and leuprolide (AAPL) or abiraterone, prednisone, leuprolide (APL) for 6 cycles (1 cycle=28 days) followed by radical prostatectomy. Surgical specimens also were centrally reviewed. The primary outcome was to determine the rate of pathologic complete response or minimum residual disease (minimum residual disease, tumor ≤5 mm).
While, the secondary endpoints included prostate-specific antigen response, positive margin rate, and safety.
Magnetic resonance imaging and tissue biomarkers of pathologic outcomes were explored.
The results of the study are as follows:
· The combined pathologic complete response or minimum residual disease rate was 22% in the AAPL arm and 20% in the APL arm.
· No new safety signals were observed.
· There was low concordance and correlation between post-therapy magnetic resonance imaging assessed and pathologically assessed tumor volume.
· PTEN-loss, ERG positivity and the presence of intraductal carcinoma was associated with an extensive residual tumor.
Thus, the researchers concluded that Intense neoadjuvant hormone therapy in high-risk prostate cancer resulted in favorable pathologic responses (tumor <5 mm) in 21% of patients, which were similar between both the treatment arms.
A study titled, "Results of a Randomized Phase II Trial of Intense Androgen Deprivation Therapy before Radical Prostatectomy in Men with High-Risk Localized Prostate Cancer" by McKay R et. al published in The Journal of Urology.