COMBINED ORCHIECTOMY AND EXTERNAL RADIOTHERAPY VERSUS RADIOTHERAPY ALONE FOR NONMETASTATIC PROSTATE-CANCER WITH OR WITHOUT PELVIC LYMPH-NODE INVOLVEMENT - A PROSPECTIVE RANDOMIZED STUDY

Purpose: We compare the combination of orchiectomy and radiotherapy to radiotherapy alone as treatment for pelvic confined prostate cancer, that is T1-4, pN0-3, M0 (TNM classification). Materials and Methods: I n this prospective study 91 patients with clinically localized prostat e cancer were, after surgical lymph node staging, randomized to receiv e definitive external beam radiotherapy (46) or combined orchiectomy a nd radiotherapy (45). Patients treated with radiotherapy alone had and rogen ablation at clinical disease progression. The effects on progres sion-free, disease specific and overall survival rates were calculated . Results: After a median followup of 9.3 years (range 6.0 to 11.4) cl inical progression was seen in 61% of the radiotherapy only patients ( group 1) and in 31% of the combined treatment patients (group 2) (p = 0.005). The mortality was 61 and 38% (p = 0.02), and cause specific mo rtality was 44 and 27%, respectively (p = 0.06), in groups 1 and 2. Th e differences in favor of combined treatment were mainly caused by lym ph node positive tumors. For node negative tumors there was no signifi cant difference in survival rates. Conclusions: The progression-free, disease specific and overall survival rates for patients with prostate cancer and pelvic lymph node involvement are significantly better aft er combined androgen ablation and radiotherapy than after radiotherapy alone. These results strongly suggest that early androgen deprivation is better than deferred endocrine treatment for these patients.