Immediate hormones in men with positive lymph nodes after radical prostatectomy is associated with a progression free survival benefit of 14 years versus 2.4 years if just watched and better overall and prostate cancer specific survival at 12 years
In this landmark study 100 men with positive lymph nodes at pelvic lymph node dissection during a radical prostatectomy operation were randomsied to either immediate hormone therapy with continuous 3.6mg monthly goserelin or bilateral orchiectomy or to be observed and have delayed hormones if needed. The follow up was 12 years. The pathological outcomes of these 100 men were interesting in that 60-70% had either seminal vesicle invasion or positive surgical margins making the cohort 2/3 pT3 disease. The average number of lymph nodes harvested from the standard pelvic node dissection carried out was 10-11, and most often 2 nodes were positive. The pre operative mean PSA is not given. The Gleason grades for both groups were 22% 6, 55% 7, <15% 8-10. The overall survival, cancer specific survival and progression free survival were all significantly better in men who got immediate hormones. The pre operative CT scan in the 100 men were all normal with no lymph nodes detected pre operatively. So patients with positive nodes at radical prostatectomy should go onto immediate hormones. To sum up all results favored immediate hormones over the 12 years:
- overall mortality was lower 36% immediate hormones v 55% death if observed
- death from prostate cancer 15% immediate hormones v 49% if observed
- PSA recurrence rates 47% immediate hormones v 86% if observed
- Mean progression free survival with immediate hormones was 14 years v 2.4 years if watched.