Abstract: PD55-04
Sources of Funding: None

Introduction

The safety of active surveillance (AS) remains topic of debate, but must be evaluated in light of results from the &[prime]golden standard&[prime] therapies, e.g. radiotherapy (RT) and radical prostatectomy (RP). The ProtecT study published 10-yr outcomes after randomization to active monitoring (AM), RT or RP; with higher risk patients and a less strict follow-up protocol than contemporary AS. In the European Randomized study of Screening for Prostate Cancer (ERSPC) Rotterdam, a subgroup of patients also received AM/AS, although more often according to a strict protocol (e.g. PRIAS).

Methods

We evaluated death rates among men with low to intermediate risk prostate cancer (PC) treated with AS, RT or RP in the ERSPC and compared these to ProtecT. Men with low risk (Gleason score (GS) 6, cT1C/cT2A) and intermediate risk (GS ≤3+4, cT1c/cT2) PC, diagnosed in the 1st and 2nd screening round (1993-2003) were included. Controlling for age, PSA, clinical stage, GS and comorbidities, we performed cox proportional hazard analyses.

Results

Of the 2280 PC patients, 905 and 1275 had low and intermediate risk PC, resp. Median age and PSA were 66.4 yrs and 4.3 ng/mL; 66,6 yrs and 4.5 ng/mL, resp. Median follow-up was 13 yrs._x000D_ In the low risk group, the hazard ratio (HR) for PC specific death for RT/RP (n=370/312) vs AS (n=223) was 0.61 (95%CI 0.18-2, p=0.41). The HR for overall death was 1.29 (95% CI 0.97-1.72). _x000D_ In the intermediate risk group, the HR for PC specific death for RT/RP (n=501/526) vs AS (n=248) was 0.65 (95%CI 0.25-1.64, p=0.36). The HR for overall death was 1.23 (95% CI 0.95-1.59). See Figure 1._x000D_ In the ProtecT study, the HR for PC specific death for RT vs. AM was 0.51 (95% CI 0.15-1.69) and for RP vs. AM 0.63 (95% CI 0.21-1.93), p=0.48. The HR for overall death was not specified (p=0.87 across treatment groups)._x000D_

Conclusions

The HR for PC specific death for AS vs immediate active therapy, between the ERSPC Rotterdam and ProtecT, seem comparable. Although the ERSPC was not randomized, but includes 13 yr complete follow-up and consensus based cause of death assignment, these data confirm that AS as an initial treatment, as compared to immediate active therapy, results in similar low PC specific death rates. In the end, quality of life and hence the personal treatment preference of the patient should be decisive.

Funding

None