Prostate-specific antigen relapse-free survival and side-effects in 734 patients with up to 10 years of follow-up with localized prostate cancer treated by permanent 125iodine implants

2010 ◽  
Vol 106 (1) ◽  
pp. 32-36 ◽  
Author(s):  
Pedro J. Prada ◽  
Germán Juan ◽  
Herminio González-Suárez ◽  
José Fernández ◽  
Isabel Jimenez ◽  
...  
2004 ◽  
Vol 94 (9) ◽  
pp. 1235-1238 ◽  
Author(s):  
Joji Joseph ◽  
Bashar Al-Qaisieh ◽  
Daniel Ash ◽  
David Bottomley ◽  
Brendan Carey

1994 ◽  
Vol 12 (7) ◽  
pp. 1402-1407 ◽  
Author(s):  
B Chauvet ◽  
C Félix-Faure ◽  
N Lupsascka ◽  
J Fijuth ◽  
Y Brewer ◽  
...  

PURPOSE To assess the prognostic significance of serum prostate-specific antigen (PSA) in the monitoring of patients with localized prostate cancer treated with primary radiation therapy, we analyzed the data from 179 patients treated at our institution between 1987 and 1990. PATIENTS AND METHODS One hundred seventy-nine previously untreated patients received radiation at 69 Gy to the prostate with curative intent for prostate adenocarcinoma. The median follow-up duration is now 41 months. PSA levels were measured before radiotherapy and then evaluated periodically. RESULTS Baseline levels were greater than 4 ng/mL in 83% of cases and were significantly correlated with clinical tumor stage (P = .002). Six months after completion of therapy, PSA values had returned to normal in 53% of the patients with initially elevated values. At the time of analysis, 32 patients have relapsed, including three of 30 patients (10%) with normal initial and 6-month values, five of 79 patients (6%) with initially elevated but normal 6-month values, and 24 of 69 patients (35%) with persistently elevated PSA levels at 6 months. Actuarial 4-year relapse-free survival was significantly correlated with initial and 6-month PSA values (84% in patients with normal 6-month values v 60% in patients with persistently elevated levels). Furthermore, when the relative decline between initial and 6-month PSA values exceeded 50%, the crude rate of recurrence was 14% as opposed to 34% when it failed to exceed 50%. The 4-year relapse-free survival rates were 77% and 59%, respectively (P = .008). By multivariate analysis restricted to the patients with elevated baseline PSA levels, the rate of decline of PSA values reached the highest prognostic significance (P < .0001). Age at diagnosis, clinical tumor stage, and Gleason score only reached statistical significance in univariate analysis. CONCLUSION PSA values are of major prognostic significance in assessing the 4-year results of radical radiation therapy for localized prostate cancer. The rate of decline of PSA values is the strongest predictor of outcome and might help to identify a subset of patients with poorer prognosis who may benefit from early hormonal therapy.


2020 ◽  
Vol 38 (26) ◽  
pp. 3032-3041 ◽  
Author(s):  
Wanling Xie ◽  
Meredith M. Regan ◽  
Marc Buyse ◽  
Susan Halabi ◽  
Philip W. Kantoff ◽  
...  

PURPOSE Recently, we have shown that metastasis-free survival is a strong surrogate for overall survival (OS) in men with intermediate- and high-risk localized prostate cancer and can accelerate the evaluation of new (neo)adjuvant therapies. Event-free survival (EFS), an earlier prostate-specific antigen (PSA)–based composite end point, may further expedite trial completion. METHODS EFS was defined as the time from random assignment to the date of first evidence of disease recurrence, including biochemical failure, local or regional recurrence, distant metastasis, or death from any cause, or was censored at the date of last PSA assessment. Individual patient data from trials within the Intermediate Clinical Endpoints in Cancer of the Prostate–ICECaP–database with evaluable PSA and disease follow-up data were analyzed. We evaluated the surrogacy of EFS for OS using a 2-stage meta-analytic validation model by determining the correlation of EFS with OS (patient level) and the correlation of treatment effects (hazard ratios [HRs]) on both EFS and OS (trial level). A clinically relevant surrogacy was defined a priori as an R2 ≥ 0.7. RESULTS Data for 10,350 patients were analyzed from 15 radiation therapy–based trials enrolled from 1987 to 2011 with a median follow-up of 10 years. At the patient level, the correlation of EFS with OS was 0.43 (95% CI, 0.42 to 0.44) as measured by Kendall’s tau from a copula model. At the trial level, the R2 was 0.35 (95% CI, 0.01 to 0.60) from the weighted linear regression of log(HR)-OS on log(HR)-EFS. CONCLUSION EFS is a weak surrogate for OS and is not suitable for use as an intermediate clinical end point to substitute for OS to accelerate phase III (neo)adjuvant trials of prostate cancer therapies for primary radiation therapy–based trials.


1995 ◽  
Vol 13 (2) ◽  
pp. 459-463 ◽  
Author(s):  
M J Zelefsky ◽  
S A Leibel ◽  
K E Wallner ◽  
W F Whitmore ◽  
Z Fuks

PURPOSE To determine the prognostic significance of a normal serum prostate-specific antigen (PSA) level in patients with prostatic cancer with long-term follow-up evaluation after radiotherapy. MATERIALS AND METHODS PSA information was available in 403 patients (38%) who were treated with pelvic lymph node dissection and retropubic radioactive iodine-125 implantation. One hundred eighty-two patients had a normal serum PSA level (< or = 4.0 ng/mL) the first time this test was conducted during the follow-up period, designated PSA-1. RESULTS Among patients with PSA-1 values < or = 1.0 ng/mL, the 5-year PSA relapse-free survival rate was 85% compared with 27%, respectively, among those with PSA values in the higher range of normal (P < .00001). Multivariate analysis demonstrated that only a PSA-1 value greater than 1.0 to < or 4.0 (P < .00001) and grade II/III histology (P = .009) had a negative impact on continued PSA relapse-free survival. The only independent variable identified by a multivariate analysis to affect local relapse-free survival (LRFS) was a PSA-1 value greater than 1.0 to < or = 4.0 ng/mL (P < .004), while high-grade histology (P < .0001) and local failure (P < .001) were the only significant variables to affect distant metastases-free survival (DMFS). CONCLUSION Patients with PSA values < or = 1.0 ng/mL are significantly less likely to have a subsequent relapse after therapy than those with levels greater than 1.0 to < or = 4.0 ng/mL. Continuously maintained PSA levels of < or = 1.0 ng/mL after treatment may serve as an end point for early evaluation of the efficacy of experimental radiotherapy protocols in prostate cancer.


1992 ◽  
Vol 10 (8) ◽  
pp. 1208-1217 ◽  
Author(s):  
M A Ritter ◽  
E M Messing ◽  
T G Shanahan ◽  
S Potts ◽  
R J Chappell ◽  
...  

PURPOSE A study of preradiation and postradiation, serial serum prostate-specific antigen (PSA) levels was performed in patients who had clinically localized prostate cancer. The prognostic value of the PSA in pretreatment evaluation and posttreatment follow-up was assessed. PATIENTS AND METHODS Sixty-three patients who presented with clinically localized prostate cancer and who were treated with external-beam radiation therapy were followed-up for a median of 25 months. A serum PSA and physical examination were performed at 3-month intervals, and a bone scan was done yearly. An increase in PSA triggered an additional metastatic workup. Prostate rebiopsy was performed for new, palpable nodules or for a serial increase in PSA in the context of a negative metastatic workup. RESULTS Forty-one patients remained recurrence-free and 22 recurred clinically, 15 distantly and seven locally. The PSA was the strongest, independent, pretreatment prognostic indicator (P = .019) among pretreatment PSA, stage, and grade, but lost significance when the serum prostatic acid phosphatase (PAP) status was included. The initial rate of the PSA decrease after radiation (median half-life, 2.6 months) failed to predict outcome. Recurrence-free patients reached postradiation PSA levels that were equivalent to those reported in disease-free male populations; failure of the PSA to reach such normal levels was a multivariate predictor of subsequent failure (P less than .037). All clinicopathologic documentations of failure were preceded by an increase in PSA levels during follow-up. Delayed versus early PSA increase was associated with clinically localized versus metastatic first recurrence. CONCLUSIONS The serum PSA is an independent pretreatment and posttreatment predictor of outcome. Additionally, for a median follow-up of 25 months, delayed PSA failure is associated with clinically localized rather than metastatic recurrence, a relationship that may help in selection for local salvage therapy.


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