Introduction: The aim of this study is to evaluate the early oncologic benefit of a strict surveillance protocol and early salvage radiotherapy (sRT) in the postoperative management of prostate cancer (PCa) patients with intermediate-high risk of recurrence after radical prostatectomy (RP).
Material and methods: We prospectively enrolled all the PCa patients submitted to RP between October 2016 and December 2018 at our Institution and included in a IRB-approved follow-up protocol (EASY-1: EArly Salvage RadiotherapY-1). Inclusion criteria were: PCa patients treated with RP; pT2 PCa with positive surgical margins (R1) or pT3a regardless surgical margins status or pT3b with negative surgical margins (R0); PSA undetectable at 40 days after surgery. Lymph node invasion was considered as exclusion criteria. The surveillance protocol included PSA dosage every two months after surgery during the first year, then every three months during the second and third year, followed by PSA every 4 months till the fifth year. Early sRT has been performed for patients with biochemical relapse (two consecutive values of PSA ≥0.2 ng/ml) and PSA value £ 0.5 ng/ml.
Results: Of the initial cohort of 229 patients, 7 were excluded from our study, due to PSA values at 40 days higher than 0,1 ng/mL and scheduled for adjuvant RT.
Our analyses included 222 patients with a minimum follow up of 2 months. Patients were stratified into two groups according to presence of BCR. Men who experienced BCR (n=21, 9.5%) were younger (p=0.02) and had a significantly higher clinical Gleason grade groups compared to individual without BCR (p=0.03, Table 1). Between two group we did not found any other significant difference concerning perioperative characteristics. Overall 63 (28.4%), 97 (43.7%), 43 (19.4%) and 19 (8.6%) patients revealed pT2R1, pT3aR0, pT3a R1 and pT3bR0 disease, respectively (Table 2). The median (IQR) follow-up of the entire population was 16 (9-24) months, and it was found to be significantly higher for the patients who had BCR (15 vs. 22; p=0.004). The median (IQR) time to BCR was 10 (7-18) months, with a median PSA at BCR of 0.2 ng/mL (0.17 – 0.4). Out of the 21 (9.5%) patients scheduled to sRT, 4 have not met the criteria for early sRT due to PSA values > 0,5 ng/mL (Table 3). The overall BCR free survival (BCR-FS) rate was 94.1% at 1 year (Figure 1). After stratifying according to pathologic characteristics, the BCR-FS rates were 95.2%, 96.9%, 88.9% and 89.5% in pT2 R1, pT3a R0, pT3a R1 and pT3b R0, respectively (Figure 2; p=0.1).
Conclusions: Strict surveillance with PSA monitoring every two months during the first year after surgery and early detection of BCR can spare immediate aRT and defer sRT within 1 years in a consistent proportion of PCa patients with intermediate-high risk of recurrence after RP. The survival benefit of such aggressive surveillance and modulated early sRT needs to be evaluated at longer follow up.
