European Urology

3. Results

Two hundred thirty out of 250 patients met the criteria for AS (20 patients had not been followed for 12 mo). The mean age of the AS patients at diagnosis was 63.4 yr of age (median: 64; range: 42–79), with a mean PSA value of 5.07 ng/ml (median: 4.76). The mean follow-up for the cohort was 44 mo (median: 32; range: 12–208; Table 1).

Fifty percent of patients had no tumor on the first rebiopsy; 46% continued to have small-volume Gleason score 6 tumors. Six patients (2.5%) had Gleason grade 4, and three others had an increase in tumor volume. On the second rebiopsy, 15 patients had Gleason grade 4. On the third rebiopsy, three patients had Gleason grade 4. Five percent of patients who had no tumor in the first or second rebiopsy were treated, compared with 16.5% who had focal Gleason 6 on the first rebiopsy. There was no tumor in 49%, 52%, and 71% of the second, third, and fourth rebiopsies, respectively.

Of the 230 men in the AS cohort, 32 (14%) were treated over a mean follow-up of 33 mo (median: 31; range: 12–92). The mean age of the treated population at diagnosis was 65.3 yr of age; the mean PSA level (at diagnosis) was 5.66 ng/ml (Table 1). The mean age at time of treatment was 68.5 yr of age (range: 44–84).

Twelve of the 32 treated patients had TP, 14 had interstitial or external-beam RT (EBRT), and 6 underwent hormone therapy (HT; Fig. 1). Seven patients treated with TP had Gleason score 3 + 4 or 4 + 3 on the TP specimen; two had Gleason score 3 + 5 or 4 + 4 (Table 2). The mean follow-up post-surgery was 30 mo (median: 35). None of the TP patients have had biochemical recurrence (BCR). No patient has died of PCa.

A Kaplan-Meier analysis predicted that 85.7% of the entire AS cohort would be free from treatment at 5 yr (Fig. 2). Logistic regression was performed to determine which variables best predict those patients who would likely not undergo treatment. PSA doubling time (PSA DT) and clinical stage were not predictors for treatment. Any tumor at the first rebiopsy was a predictor for treatment (p = 0.011; coefficient of 1.517).

The SHIM and ICI-SF were completed by 172 of 230 patients. On the ICI-SF, 30% of AS patients demonstrated some degree of incontinence; few were bothered by it (bother score >0). The mean initial and final ICI scores were not significantly different 1.16 and 1.1 respectively.

Forty-nine percent of patients had at least moderate erectile dysfunction (ED), as measured by the SHIM. The mean scores (initial mean score:14.2 [median: 17.50]; final mean score: 11.8 [median: 13]) also indicated moderate ED in the cohort at large. A paired-sample student t test analyzing the initial/last SHIM scores revealed that the last scores were significantly lower (p <0.001). The significant increase in ED was seen in three of four age groups (40–49; 50–59; 60–69; 70–79; Table 3). There was no significant difference in the mean age between patients with ED and patients with normal erectile function (p = 0.75).

AS patients with SHIM scores ≥21 (30%) and normal erectile function at diagnosis were studied to determine whether multiple TRUS biopsies had an effect on potency. The group's mean age was 58.57 yr of age (median: 58.50). Interestingly, over a mean follow-up of 35 mo (median: 28), there was a significant increase (p ≤ 0.001) in ED (mean: 23.65 to mean: 17.98) from the initial SHIM.

Our AS guidelines were met by 219 out of 2100 patients who initially had TP rather than selecting AS. Only 22% of these patients contained Gleason grade 4 or 5 in the surgical specimen. In the 219 patients, 59 (27%) had a positive margin, 17 (7.5%) had extraprostatic extension (EPE), and 4 (2%) had seminal vesicle invasion (SVI; Fig. 1). There was no significant difference in the positive margin rate between initially treated patients and patients treated following AS (p = 0.52), EPE (p = 0.73), or SVI (p = 0.79).