Objective
To evaluate risk of prostate cancer biochemical recurrence (BCR) after radical prostatectomy (RP) in men receiving vs not receiving testosterone replacement therapy (TRT).
Patients and Methods
A total of 850 patients underwent RP by a single surgeon. All patients had preoperative testosterone and sex hormone‐binding globulin levels determined; free testosterone was calculated prospectively. In all, 152 (18%) patients with low preoperative calculated free testosterone (cFT) levels and delayed postoperative sexual function recovery were placed on TRT and proportionately matched to 419 control patients by pathological Gleason Grade Group (GGG) and stage. Rates and time to BCR [two consecutive prostate‐specific antigen (PSA) levels of ≥0.2 ng/mL] were compared in univariate and multivariate regression; Cox regression was used to generate a survival function at the mean of covariates.
Results
The median follow‐up was 3.5 years. There were no statistically significant differences in demographics or general health complications between groups. BCR occurred in 11/152 (7.2%) and 53/419 (12.6%) patients in the TRT and control groups, respectively. In adjusted time‐to‐event analysis, TRT was an independent predictor of recurrence‐free survival. After accounting for GGG, pathological stage, preoperative PSA level, and cFT, patients on TRT were ~54% less likely to recur (hazard ratio 0.54, 95% confidence interval 0.292–0.997). In men destined to recur, TRT delayed time to recurrence by an average of 1.5 years.
Conclusion
In our experience, TRT after RP significantly reduced BCR and delayed time to BCR. There was no identifiable general health complications associated with TRT. These findings are hypothesis‐generating and require confirmation with multi‐centred, prospective randomised controlled trials.
Biochemical recurrence (BCR) following radical prostatectomy (RP) has a limited ability to predict prostate cancer (PC) progression, leading to overtreatment, decreased quality of life, and additional expenses. Previously, we established that one-third of men with BCR in our group experienced low-risk recurrences that were safely observed without treatment. Our retrospective cohort analysis of 407 BCR patients post RP validates the use of PSA doubling time (DT) kinetics to direct active observation (AO) versus treatment following RP. The primary outcome was no need for treatment according to the predictive value of models of ROC analysis. The secondary outcome was PC-specific mortality (PCSM) according to Kaplan–Meier analysis. A total of 1864 men underwent RP (June 2002–September 2019); 407 experienced BCR (PSA > 0.2 ng/dL, ×2), with a median follow-up of 7.6 years. In adjusted regression analysis, initial PSADT > 12 months and increasing DT were significant predictors for AO (p < 0.001). This model (initial PSADT and DT change) was an excellent predictor of AO in ROC analysis (AUC = 0.83). No patients with initial PSADT > 12 months and increasing DT experienced PCSM. In conclusion, the combination of PSADT > 12 months and increasing DT was an excellent predictor of AO. This is the first demonstration that one-third of BCRs are at low risk of PCSM and can be managed without treatment via DT kinetics.
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