Radiotherapy is given for salvage after RP in 3 settings: (1) for a DR-PSA after the PSA has dropped to an undetectable level immediately postprostatectomy, (2) for a persistently detectable PSA after surgery, and (3) for treatment of a palpable recurrence within the prostatic fossa. This division may be important because the initial considerations in evaluation may be different, and there are reports of a distinction in prognosis. However, many retrospective series were based on small patient numbers and did not separate these patients, making conclusions difficult.
The time to a rising PSA after prostatectomy, the prostatectomy Gleason score, and the PSA doubling time (PSADT) are independent predictors of distant metastasis and mortality.25,26 When the time to BF is <3 years (the PD-PSA patients would be included in this group), Gleason score is ≥8, and PSADT is <9 months, the risk of death due to prostate cancer at 5 years is ≥19%.26 This risk increases to ≥74% at 10 years. PSADT has taken on much more importance over the last 5 years.42,53,54 If the above parameters included a postoperative PSADT of <3 months, nearly 50% will die within 5 years. Even the PSA kinetics prior to prostatectomy may be an independent determinant of mortality.55–57 A rapidly rising PSA prior to RP or prior to RT connotes a poor prognosis, suggestive of occult metastatic disease even if the metastatic workup is negative. Although our ability to predict progression after SRT has improved, we are a long way from making conclusive judgments on whether SRT would benefit most men. There is a need to optimize treatment selection with the goal of prolonging survival without unnecessary toxicity, particularly in the setting of rapid PSA kinetics.
Factors indicating that postprostatectomy RT for a PD-PSA might be beneficial include extensive extraprostatic extension (particularly in those with high-grade disease) or positive margins. Other indicators that there may be disease in the prostatic fossa are SVI, a cut-through of the prostate (a partial prostatectomy when there is palpable, biopsy, or imaging evidence of prostate remaining), or incomplete removal of the seminal vesicles in the setting of T3 disease (especially with ECE at the base or with SVI). In the absence of these features and with a PSA that is rising quickly (doubling time <6 months), the probability of distant metastasis is high,25,53,58–60 and SRT is discouraged.
The results of SRT have been relatively poor, with 5-year FFBF rates in most series ranging from 10% to 66%.3–6,41,59,61–66 The following factors have been correlated with worse FFBF rates: Gleason score >7, SVI, high pre-RT PSA (>1 to >2.5 ng/mL), short PSADT, negative prostatectomy margins, treatment for a PD-PSA (vs. a DR-PSA), a palpable prostatic fossa mass, and RT dose <65 Gy.
In general, when the PSA remains detectable after RP, the risk of distant metastasis is greater than when the PSA goes to undetectable and then rises later. Thus, outcomes of SRT in most series have been worse for patients with a PD-PSA compared with a DR-PSA.3,4,6,63 However, some series have not found a significant difference in FFBF rates between the 2 groups.5,42,65,67 While distinguishing between the groups seems to be the most objective way of evaluating the utility of SRT, most of the studies reporting SRT outcomes do not separately analyze the DR-PSA and the PD-PSA patients. In addition, all of these studies are retrospective, and most include small numbers of patients.
As described earlier in the text, the PSADT is an important predictor of SRT outcome. The shorter it is, the greater the risk of death due to prostate cancer. A doubling time of ≤10 months in the setting of a DR-PSA or a PD-PSA indicates a higher likelihood of occult metastatic disease,25,42,53,58–60 thus rendering postoperative RT much less effective. Another study showed that a PSADT of ≥5 months predicted a response to SRT (a response was defined as a PSA nadir of ≤0.1 ng/mL).68 One caveat concerning the PSADT as a reliable predictor of distant metastasis is that when the PSA is below 1 ng/mL, the estimates may be inaccurate.60,69,70 In reports of postoperative RT, few have identified PSADT as a predictor of FFBF. In a preliminary recursive partitioning analysis of about 1200 men in a pooled multi-institutional database, PSADT was not independently related to outcome, while pre-RT PSA, Gleason score, and margin status were.71 Standards are needed for when the PSADT calculation begins (from the PSA just prior to when an accelerated rise occurs or from the time of the first detectable PSA) and the minimum number of PSA values required to accurately calculate a PSADT.
The pre-RT PSA has been found to be the most consistent predictor of FFBF in both univariate and multivariate analyses of SRT.72–75 While a clear pre-RT PSA cutpoint has not yet been defined, evidence suggests that lower pre-RT PSAs are associated with higher FFBF rates. The best results have been seen when the pre-RT PSA is ≤1 ng/mL. A significant decline in FFBF is seen when the pre-RT PSA increases from ≤1 ng/mL to 2, and then to >2 ng/mL.
Other important prognostic factors include the Gleason score, margin status, and seminal vesicle invasion. Gleason scores of ≤7 predict for a better prognosis compared with scores of 8 to 10. A positive margin often indicates residual disease in the prostate bed, for which SRT is effective, and FFBF rates are higher when this is the case. Seminal vesicle invasion has been found to be a determinant of outcome in multivariate analysis in many series as well, with worse FFBF rates when the seminal vesicles were involved, due to these patients being at a higher risk of developing subsequent metastatic failure (Table 3).3,41,42
The use of concurrent ADT with ART and SRT could impact the course of the disease hypothetically by 3 principal mechanisms: (1) better disease eradication locally (recurrence in a hypoxic scar may be radioresistant), (2) improved disease control distantly (cells in microscopic metastatic deposits might retain sensitivity to ADT), and (3) the combination of ADT and RT may alter the PSA kinetics in patients who eventually relapse.76,77 The mechanism of the effect on the kinetics of BF and the delayed appearance of distant metastasis is unknown. However, any improvement upon the current results of ART and SRT is potentially worthwhile. In some reports,4,6,41,78–83 ADT had positive results in patients at high risk of experiencing a rising PSA after SRT (eg, a pre-RT PSA >1 ng/mL). Randomized trials are needed and are in progress (Table 4).
The optimal timing of ART versus SRT for patients with high-risk pathologic features remains controversial. Some have supported watchful waiting before administering SRT.84 This rationale is based on 3 points. First, half of men will be treated unnecessarily. Second, salvage rates are fairly good when the pre-RT PSA is low (≤1.0 ng/mL).61,78,85–87 Third, the progression to distant metastasis after BF may be long.25,26 It is beyond the scope of this article to compare ART to SRT in depth; however, it should be noted that the addition of SRT to patients who were originally in the observation arm of the Southwest Oncology Group randomized trial still resulted in a higher rate of metastatic failure in these patients compared with early adjuvant therapy.51 Without a randomized trial to eliminate selection bias, it is impossible to ascribe an advantage to 1 strategy over the other based on FFBF outcomes. At least ART has a proven benefit in randomized prospective studies, supporting first principles that RT treatment should be used if the risk of local failure is >20% and the side effect profile is reasonable. Local persistence leads to distant metastasis in most malignancies, and there is evidence that this is the case for prostate cancer.88–91 In younger men with a long life expectancy, ART should be considered.
LNI portends a very poor prognosis, with a high rate of distant failure. Although there are emerging data indicating that RP or RT should be used along with ADT when LNI is identified,92 there is no well-established benefit from this approach as yet. ART might be of some value when there is evidence of an appreciable locoregional tumor burden, such as extensive positive margins. There are insufficient data on the subject of pelvic nodal irradiation to make any recommendations, even when LNI has been documented (Table 5).93
* A high percentage of radical prostatectomy patients with high-risk pathologic features (positive surgical margins, extraprostatic extension of cancer, SVI) will experience a subsequent BF, with failure often due to the progression of residual disease within the surgical bed.
* The addition of adjuvant radiation therapy directed at the prostate fossa to these patients has been shown in 3 prospective randomized trials to improve the biochemical freedom from failure rate among the irradiated patients and, in 1 trial, to provide an improvement in metastasis-free and overall survival.
* Salvage radiation therapy, in which patients with biochemically detectable disease undergo radiotherapy to the prostate bed, has also been shown to improve freedom from BF, although the impact on overall survival remains uncertain.
* The appropriate radiation dose to the prostate fossa in the adjuvant or salvage setting is 66 to 70.2 Gy. Higher doses may be appropriate if there is an evidence of gross recurrence within the prostate bed.
* The addition of pelvic radiotherapy to prostate fossa radiation is generally discouraged, although it may be appropriate in certain clinical situations (absence of lymph node dissection, evidence of nodal involvement at prostatectomy or on imaging studies, etc).
* The benefit of neoadjuvant/adjuvant ADT is the subject of ongoing clinical trials, and its use is discouraged outside of the protocol setting.
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