Abstract

4583 Background: PC recurs in 1/3 of pts after local treatment indicating micrometastases are frequently undetected. Based on established risk factors (RF) for recurrence - tumor stage (T), serum PSA (sPSA) and biopsy Gleason score (GL), pts are stratified in low (T≤2A + PSA<10 ng/ml + GL<7); intermediate (T2B or PSA10–20 or GL=7) or high (T≥2C or PSA>20 or GL>7) risk. Although helpful, quantification of PSA mRNA in high-risk N0 PLN pts might identify those with prognostically-relevant tumor loads of metastases whose potential benefit from early systemic therapy would override its morbidity. Methods: Bilateral N0 PLN of 341 PC pts undergoing radical prostatectomy (RP) or radiation (XRT) were prospectively collected with baseline data and sPSA follow-up (f/u). In 318 cases, PSA mRNA copies were quantified by QRT-PCR. Duplicate test samples were adjusted to a fixed housekeeping gene transcript level that minimized false positives. We assessed whether a threshold PSA copy number (tPSA) was associated with progression free survival (PFS), as well as with RF. PSA failure was defined as a rise ≥0.2 after RP or by the first of three rises after XRT. Results: 70 (21%) pts had 0 PSA copies, 175 (51%) >0–50, 20 (6%) >50–100, 53 (16%) >100; 23 (7%) were inadequate. At 4 years median f/u, a significant correlation emerged for tPSA copies ≥100 vs <100 and PFS, plus interactions with sPSA >10, GL >7 and high-risk group (Table). By Cox regression analysis relative risk for PSA ≥100 copies (95% CI) was 2.18 (1.18–4.01) after adjusting for categorical RF and 1.98 (1.06–3.69) for continuous RF. Conclusions: PSA QRT-PCR ≥100 defined an occult tumor burden level in N0 PLN of independent prognostic value overall and is especially predictive of recurrence at 4 years in high-risk pts. No significant financial relationships to disclose.

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