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Biomedical subjects

E A Klein

Publications and source records attributed to E A Klein.

At least 55 records · Page 3Linked to original sources
PubMed1999

Biochemical failure does not predict overall survival after radical prostatectomy for localized prostate cancer: 10-year results.

OBJECTIVES: To compare rates of overall survival in men with biochemical failure (bF) to those with no bF after radical prostatectomy for localized prostate cancer. METHODS: Radical prostatectomy was performed in 1132 consecutive patients between June 1986 and September 1998, and bF (prostate-specific antigen [PSA] 0.2 ng/mL or greater) was documented in 213 patients (19%), with a mean follow-up of 56 months (range 1 to 125). Ninety-nine patients were treated with androgen ablation and/or radiation therapy at the time of bF. Kaplan-Meier estimates of bF, metastasis-free survival, and overall survival were generated and compared using the log-rank test. RESULTS: The 10-year overall survival rates for patients with bF (88%) versus no bF (93%) were similar (P = 0.94). The survival rates of patients with bF were not statistically different than those of patients without bF when compared by age older than 65 years, preoperative PSA greater than 10 ng/mL, biopsy or specimen Gleason score 7 or greater, clinical Stage T2b-3, presence of extracapsular extension, positive surgical margins, and seminal vesicle invasion. Patients who received second-line treatment also had a similar 10-year overall survival rate (86%, P = 0.97). For the 213 patients with bF, the metastasis-free survival rate at 10 years was 74%. The overall survival rate for patients with distant metastasis (56%) was markedly lower (P <0.001) than for those without distant metastasis. CONCLUSIONS: At 10 years, patients with a PSA recurrence after radical prostatectomy for localized disease have an excellent overall survival equivalent to those without a detectable PSA. Within this period, the clinical significance of a detectable PSA needs to be further evaluated.

Aged↗
PubMed1999

T-cell adoptive immunotherapy of metastatic renal cell carcinoma.

OBJECTIVES: To determine the feasibility and toxicity of the adoptive transfer of ex vivo-activated T lymphocytes that have been sensitized to autologous tumor vaccine in vivo. METHODS: Twenty patients with extensive metastatic renal cell carcinoma received systemic adoptive immunotherapy with autologous T cells in the absence of conjunctional interleukin-2 (IL-2) administration. Patients were vaccinated intradermally with irradiated autologous tumor cells and granulocyte-macrophage colony-stimulating factor as an adjuvant to stimulate an immune response. Inguinal lymph nodes draining the vaccine site were surgically removed, and the cells were stimulated with staphylococcal enterotoxin A followed by expansion in 60 IU/mL IL-2, and in some cases additionally stimulated with anti-CD3 monoclonal antibody and IL-2, to obtain a large number of cells. RESULTS: The staphylococcal enterotoxin A/IL-2 activation induced vigorous proliferation of T cells (median expansion 26-fold) that were a mixture of CD4 and CD8 T lymphocytes. Activated cells were infused intravenously at doses ranging from 2x10(9) to 9.5x10(10). There was minimal toxicity consisting of grade 1 or 2 fever and nausea, and the entire treatment was delivered as outpatient therapy. One patient had a partial response, one had a mixed response, and 8 had stable disease lasting at least 5 months. CONCLUSIONS: Adoptive transfer of ex vivo-activated, tumor vaccine-primed lymph node cells is feasible and is associated with minimal toxicity when used alone. These results warrant further study in a Phase II trial.

Adult↗
PubMed1999

Rational use of chemotherapy. It is not just rat poison.

The role of chemotherapy in the management of advanced prostate cancer is expanding. Multiple regimens that use a variety of drugs have been developed. A chemotherapy regimen may appear to be a collection of randomly chosen agents. This article presents the theoretic foundation for the development of combination chemotherapy.

Animals↗
PubMed1999

Surgery for invasive bladder tumors: technique and outcome.

The operative management of invasive transitional cell carcinoma has advanced significantly in the past year, particularly with respect to continent urinary diversion. The long term safety and efficacy of this form of urinary reconstruction is being established in terms of both operative and metabolic complications. The availability of continent diversion can decrease the interval to cystectomy and therefore may impact positively on survival. It has also been shown that continent diversion can safely be offered to patients at high risk for local recurrence. The importance of urethral sensory threshold on postoperative continence is being established. These findings and others continue to enhance the survival and quality of life of patients undergoing cystectomy for invasive bladder cancer.

Carcinoma, Transitional Cell↗
PubMed1999

Declining rates of extracapsular extension after radical prostatectomy: evidence for continued stage migration.

PURPOSE: Prostate-specific antigen (PSA)-based screening is responsible for a profound clinical stage migration in newly detected prostate cancers. Extracapsular extension (ECE) is an important predictor of outcome after radical prostatectomy (RP). We examined trends in the rate of ECE for cancers detected by PSA screening in 731 RP specimens between 1987 and 1997, when screening became routine urologic practice in the United States. METHODS: The rates of ECE were examined in 311 prostates with nonpalpable (stage T1c) disease and 420 with palpable but clinically localized (stage T2) disease. Specimens were step-sectioned and examined by a senior pathologist. Rates of ECE were compared with respect to time, and logistic regression was used to identify predictors of ECE. RESULTS: The rate of ECE decreased from 81% to 36% during the 10-year observation period. Multivariateanalysis involving clinical tumor stage, preoperative serum PSA level, and Gleason score demonstrated that year of treatment was an independent predictor of ECE, with a two-fold reduction of risk occurring during the study period (P <. 001; odds ratio, 1.96; 95% confidence interval, 1.37 to 2.78). CONCLUSION: PSA screening has resulted in a downward trend in pathologic stage in clinically localized prostate cancer, independent of preoperative PSA level, tumor stage, and Gleason score. This time-dependent downward stage migration suggests the need for continuous updating of predictive nomograms and caution in interpreting differences in contemporarily treated patients compared with historical controls. Further study is needed to determine whether this trend will translate into improved disease-free survival.

Aged↗
PubMed1999

Impact of diagnostic ureteroscopy on long-term survival in patients with upper tract transitional cell carcinoma.

PURPOSE: We determine whether diagnostic retrograde ureteroscopy for evaluation of upper tract transitional cell carcinoma adversely affects survival outcomes in terms of urothelial and metastatic tumor recurrence, and tumor-free and overall survival. MATERIALS AND METHODS: A total of 96 patients underwent total nephroureterectomy or resection of the distal ureter with a bladder cuff for upper tract transitional cell carcinoma. Of the patients 48 (study group) had undergone preoperative diagnostic ureteroscopy while 48 (control group) had not. Grade and stage of disease were compared, and time to recurrence, and disease-free and overall survival were analyzed. RESULTS: Grade and stage of disease were equivalent in both groups. There were no significant differences in recurrence rates, time to recurrence or mortality between the groups. Metastases developed in 9 patients (18.8%) in the control group and 6 (12.5%) in the study group (p = 0.58), while 5 (10.4%) in each group died of metastases of upper tract carcinoma (p = 1.00). Kaplan-Meier estimates were 0.67 and 0.71 for metastasis-free survival at 5 years (p = 0.25, not significant) and 0.87 and 0.76 for overall 5-year survival (p = 0.75, not significant) for the study and control groups, respectively. CONCLUSIONS: Diagnostic ureteroscopy has no clinically apparent adverse effect on long-term or disease specific survival of patients with upper tract transitional cell carcinoma who subsequently undergo standard definitive surgical management.

Aged↗
PubMed1999

How to explore the patient with a rising PSA after radical prostatectomy: defining local versus systemic failure.

We report on the various methods used to determine local or distant recurrences in patients with detectable serum prostate-specific antigen (PSA) after radical prostatectomy (RP). Studies show that variables that help predict distant metastases are PSA recurrence less than 2 years following surgery, tumors with Gleason score (GS) greater than 7, and positive seminal vesicles or positive lymph nodes at the time of surgery. In addition, studies in PSA kinetics show that short PSA doubling times, especially less than 6 months, are associated with distant recurrence and better correlated with the pattern and incidence of clinical recurrence than preoperative PSA, specimen GS, or stage alone. Studies show that although positive surgical margins are a significant risk factor for recurrence, only 40% to 50% of patients with positive margins developed an elevated PSA level within 5 years. When suspecting a local recurrence, transrectal ultrasound (TRUS) and TRUS-guided biopsies enhance the relatively inaccurate detection of local recurrence by digital rectal examination and initial prostate fossa biopsies. For distant recurrence, bone scintigrams of patients with a PSA recurrence following RP are only rarely positive and are found to have limited usefulness until the PSA increases to above 30 ng/mL. The role of immunoscintography to differentiate between local and distant recurrence is still evolving and requires further investigation. Further studies are clearly needed to enhance our ability to distinguish local from distant recurrence and to ultimately help guide therapy.

Bone Neoplasms↗
PubMed1999

Race as an independent predictor of outcome after treatment for localized prostate cancer.

PURPOSE: We analyze the outcome after prostatectomy or radiotherapy for localized prostate cancer with respect to race. MATERIALS AND METHODS: A total of 2,219 consecutive patients with prostate cancer were treated with radiotherapy (1,183) or radical prostatectomy (1,036) between June 1986 and June 1998. Initial prostate specific antigen (PSA) and biopsy Gleason scores were available in all cases. Androgen deprivation was used in 22% of men (492). Of the patients 86% (1,901) were white, including Hispanic and Asian, and 14% (318) were black. The outcomes of interest were biochemical relapse-free survival, clinical relapse-free survival and overall survival. Median followup was 24 months (range 2 to 140). RESULTS: There was no difference in the incidence of familial prostate cancer, patient age at presentation, clinical stage or biopsy Gleason scores between black and white men. However, black men had higher initial PSA levels (median 13.3 versus 8.6 for white men, p<0.001). The 5-year biochemical relapse-free survival rate was 59% for the entire group, 54% (95% confidence interval 44 to 63) for black men and 61% (95% confidence interval 57 to 65) for white men (p = 0.11). Multivariate analysis was performed for the variables of age, race, family history of prostate cancer (brother or father), initial PSA, biopsy Gleason sum, clinical T stage, treatment modality and androgen deprivation. Familial prostate cancer (p = 0.001), higher T stage (p<0.001), higher initial PSA (p<0.001), higher biopsy Gleason score (p<0.001) and use of androgen deprivation (p = 0.001) were independent predictors of biochemical failure and all other factors, including race, were not (p = 0.46). The projected 10-year clinical relapse-free survival rate was 74% for the entire group, and was identical for black and white men (p = 0.77). The projected 10-year overall survival rate for black and white men was 92 and 79%, respectively (p = 0.62). CONCLUSIONS: We have demonstrated a statistically nonsignificant trend for higher biochemical failure rates in black men presenting with localized prostate cancer. This trend could be due to the higher pretreatment PSA levels in black patients. Treatment recommendations should not differ with respect to race.

Adult↗
PubMed1999

Association between a CYP3A4 genetic variant and clinical presentation in African-American prostate cancer patients.

Prostate cancer incidence, clinical presentation, and mortality rates vary among different ethnic groups. A genetic variant of CYP3A4, a gene involved in the oxidative deactivation of testosterone, has been associated recently with prostate cancer development in Caucasians. To further investigate this variant, we evaluated its genotype frequencies in different ethnic groups and its association with clinical presentation of prostate cancer in African Americans. CYP3A4 genotypes were assayed in healthy male Caucasian (n = 117), Hispanic (n = 121), African-American (n = 116), Chinese (n = 46), and Japanese (n = 34) volunteers using the TaqMan assay. The association between CYP3A4 genotype and prostate cancer presentation was determined in 174 affected African-American men. Genotype frequency of the CYP3A4 variant differed substantially across ethnic groups, with African Americans much more likely to carry one or two copies than any other group (two-sided P < 0.0001). Among African Americans, 46% (80 of 174) of men with prostate cancer were homozygous for the CYP3A4 variant, whereas only 28% (32 of 116) of African-American healthy volunteers were homozygous (two-sided P < 0.005). A consistent positive association was observed between being homozygous for the CYP3A4 variant in African-American prostate cancer patients and clinical characteristics. Men homozygous for the CYP3A4 variant were more likely to present with higher grade and stage of prostate cancer in a recessive model [odds ratio (OR), 1.7; 95% confidence interval (CI), 0.9-3.4]. This association was even stronger for men who were >65 years of age at diagnosis (n = 103; OR, 2.4; 95% CI, 1.1-5.4). In summary, the CYP3A4 genotype frequency in different ethnic groups broadly followed trends in prostate cancer incidence, presentation, and mortality in the United States. African-American prostate cancer patients had a higher frequency of being homozygous for the CYP3A4 variant than healthy African-American volunteers who were matched solely based on ethnicity. Among the patients, those who were homozygous for the CYP3A4 variant were more likely to present with clinically more advanced prostate cancer.

Adult↗
PubMed1998

Combined nested RT-PCR assay for prostate-specific antigen and prostate-specific membrane antigen in prostate cancer patients: correlation with pathological stage.

Nested reverse transcription (RT)-PCR for prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSM) can detect circulating prostatic cells in patients with prostate cancer. We evaluated the role of a combined screening approach for PSA and PSM in prostate cancer staging. We examined the peripheral blood samples from 136 patients with adenocarcinoma of the prostate (PCA), 15 patients with benign prostatic hyperplasia, 15 normal male subjects, and 5 female subjects. The controls (benign prostatic hyperplasias, normal males, and normal females) were negative for both PSA and PSM. In patients with metastatic PCA (n = 11), 100% were positive by combined PSA/PSM (64% by PSA and 91% by PSM). In biochemical failure PCA patients (n = 18), 39% were positive by PSM, compared to only 6% by PSA. In patients with clinically localized PCA (n = 107), 48% were positive by combined PSA/PSM approach (43% by PSM and 14% by PSA). These results show that PSM is a more sensitive marker than PSA in detecting circulating prostatic cells (P < 0.0001). We correlated preoperative RT-PCR results with final pathological stages in 67 prostatectomy patients. RT-PCR positivity was 81.5% in patients with non-organ-confined disease versus 37.5% in organ-confined disease (P = 0.001). PSA/PSM RT-PCR had an odds ratio of 7.3 (95% confidence interval, 2.3-23.4; P = 0.001) in predicting tumor extracapsular extension. PSA/PSM RT-PCR was a better predictor of tumor extracapsular extension than initial serum PSA, clinical stage, and biopsy Gleason score. Our data show that PSA/PSM nested RT-PCR may provide the staging information unavailable from the current modalities. The ultimate impact of this technique in the management of patients with prostate cancer will require continued investigation.

Adenocarcinoma↗
PubMed1998

Should continent diversion be performed in patients with locally advanced bladder cancer?

OBJECTIVES: To assess the effect of local, regional, and distant recurrence on pouch function in patients with locally advanced bladder cancer treated by cystectomy and continent diversion. METHODS: A review of 64 consecutive patients undergoing orthotopic (n = 40) or continent cutaneous (n = 24) urinary diversion was performed; 25 patients (39.1%) had locally advanced cancers as defined by deep muscle invasion, extension into perivesical fat, stromal invasion of the prostate, or node-positive disease. Patients were followed at 6-month intervals with physical examination, assessment of voiding function, and computed tomography (CT) scans. RESULTS: The pelvic recurrence rate was 4.7% in the overall group and 12% in patients with locally advanced disease. In the 39 patients with organ-confined tumors, 34 (87%) are alive without evidence of recurrence and have normal pouch function with a median follow-up of 27 months. Four patients in this group receiving systemic chemotherapy for clinical recurrences have retained normal pouch function until last follow-up or death. In the 25 patients with locally advanced tumors, 15 (60%) are alive without evidence of recurrence and have normal pouch function with a median follow-up of 15 months. Seven patients in this group received a median three cycles of adjuvant chemotherapy, and 4 patients received chemotherapy for clinically evident recurrences. Surgical recovery did not delay the onset of adjuvant therapy in any patient, nor did problems specifically related to the presence of a continent pouch delay any cycle of chemotherapy in those patients treated for recurrent disease in either group. Only 1 patient (1.5%) experienced treatment-related toxicity related to the presence of a continent diversion. CONCLUSIONS: This experience suggests that the use of orthotopic or continent cutaneous diversions after cystectomy in patients with locally advanced bladder cancer is safe, does not interfere with the delivery of subsequent therapy, and allows most patients to anticipate normal pouch function even in the presence of recurrent disease.

Adult↗
PubMed1998

Initial dissection of the lateral fascia reduces the positive margin rate in radical prostatectomy.

OBJECTIVES: Positive margins predict an adverse outcome after radical retropubic prostatectomy (RRP). The effect of initial incision of the lateral pelvic fascia prior to urethral transection on positive margins rates is assessed. METHODS: The rate of positive margins in 350 consecutive RRPs is compared in two groups without hormonal pretreatment. In group 1 (n = 198), RRP was performed in standard fashion with apical dissection and urethral transection preceding dissection of the lateral pelvic fascia and mobilization of the prostate from the anterior rectal surface. In group 2 (n = 1 52), the initial step consisted of incision of the lateral pelvic fascia along the perirectal surface with prostatic mobilization off the rectum prior to urethral transection. The bladder neck and seminal vesicle dissection was identical in both groups. Specimens were step-sectioned for histologic analysis. Differences in rates of positive margins were analyzed by Fisher's exact test and logistic regression. RESULTS: The rate of positive margins was reduced from 37.4% in group 1 to 15.8% in group 2. In the logistic regression model, surgical technique, Gleason sum, serum prostate-specific antigen (PSA), and the presence of extracapsular extension were independent predictors of margin status, with group 1 being more than twice as likely to have positive margins than group 2 (P = 0.0076; odds ratio 2.198; 95% confidence interval 1.23 to 3.92). The rate of positive margins was reduced from 45.5% in group 1 to 16.7% in group 2 (P = 0.0046) for non-nerve-sparing RRP and from 33.3% to 15.5% (P = 0.0012) for nerve-sparing RRP. There were no differences in functional outcomes between groups and no rectal injuries in group 2. CONCLUSIONS: Initial dissection of the lateral pelvic fascia during RRP results in a lower rate of positive margins independent of tumor grade, clinical stage, extracapsular extension, and preoperative PSA level.

Confidence Intervals↗
PubMed1998

Comparison of goserelin and leuprolide in combined androgen blockade therapy.

OBJECTIVES: To perform exploratory analyses of data from a controlled trial that assessed the efficacy and tolerability of two antiandrogens, bicalutamide and flutamide, each combined with monthly depot preparations of leuprolide or goserelin, in patients with Stage D2 prostate cancer. One analysis compared goserelin plus antiandrogen therapy with leuprolide plus antiandrogen therapy; a second analysis compared the four combined androgen blockade (CAB) regimens. METHODS: This was a randomized, multicenter trial, open-label for luteinizing hormone releasing hormone analogue (LHRH-A) therapy, double-blind for antiandrogen therapy, with a two-by-two factorial design. Eight-hundred thirteen patients were allocated in a ratio of 2:1 to goserelin therapy (3.6 mg every 28 days) or leuprolide therapy (7.5 mg every 28 days) and 1:1 to bicalutamide therapy (50 mg once a day) or flutamide therapy (250 mg three times a day). The end points of time to progression and survival were assessed with a median of 160 weeks of follow-up. RESULTS: The percentages of progression events (70.9% versus 73.3%) and deaths (54.3% versus 56.8%) were similar for goserelin plus antiandrogen and leuprolide plus antiandrogen therapies. The hazard ratios for goserelin plus antiandrogen therapy to leuprolide plus antiandrogen therapy were 0.99 (95% confidence interval [CI] 0.84 to 1.18; P = 0.92) and 0.91 (95% CI 0.75 to 1.11; P = 0.34) for time to progression and survival, respectively. Goserelin plus antiandrogen and leuprolide plus antiandrogen therapies were generally well tolerated, and the side effects associated with depot administration occurred with a low frequency in the two groups. There were no significant differences among the goserelin plus bicalutamide, goserelin plus flutamide, or leuprolide plus bicalutamide therapy groups, but leuprolide plus flutamide therapy had a significantly poorer outcome than the other three therapies. The side-effect profiles for the four CAB groups were generally similar; diarrhea was more common among patients treated with flutamide and hematuria was more common among patients treated with bicalutamide. CONCLUSIONS: Although the results of these exploratory analyses should be interpreted with caution, they indicate that goserelin plus antiandrogen and leuprolide plus antiandrogen therapies are similarly well tolerated and have equivalent time to progression and survival, and that leuprolide plus flutamide therapy appears to be the least effective of the four CAB regimens.

Adult↗
PubMed1998

Radiation therapy versus radical prostatectomy in the PSA era: a urologist's view.

In the absence of a randomized trial directly comparing outcomes in men with localized prostate cancer treated by radical prostatectomy with treatment by radiation therapy, only an approximate answer regarding the relative efficacies of these modalities can be achieved. However, retrospective studies which examined outcomes based on pretreatment parameters intrinsic to the tumors have demonstrated that when stratified by grade and prostate specific antigen (PSA), the rates of cancer control for these therapies are similar at 5 years posttreatment. These modalities differ in other important ways, including acute toxicity, patient satisfaction, posttreatment quality of life, and ease of salvage of treatment failures. A consideration of all of these factors is necessary to arrive at the appropriate choice of therapy for each patient.

Biomarkers, Tumor↗
PubMed1998

Photodynamic therapy using porfimer sodium as an alternative to cystectomy in patients with refractory transitional cell carcinoma in situ of the bladder. Bladder Photofrin Study Group.

PURPOSE: Photodynamic therapy combines a photosensitizer, such as porfimer sodium (Photofrin), with red laser light (630 nm.) to destroy cancer cells. Investigators have reported the effectiveness of photodynamic therapy in the treatment of patients with recurrent superficial bladder cancer. We assess the safety and efficacy of 1 or 2 photodynamic treatments using porfimer sodium and controlled uniform laser light (630 nm.) as an alternative to cystectomy in patients with refractory vesical carcinoma in situ of the bladder. MATERIALS AND METHODS: A total of 36 patients with carcinoma in situ were treated with whole bladder photodynamic therapy as an alternative to cystectomy. In all patients at least 1 course of bacillus Calmette-Guerin (BCG) had failed. Each patient received a single whole bladder photodynamic therapy treatment, consisting of 2 mg./kg. porfimer sodium intravenously followed 40 to 50 hours later by intravesical red light (630 nm.) at 15 J./cm.2. Post-photodynamic therapy evaluations included weekly telephone contact to assess acute adverse reactions, and assessment of efficacy and bladder toxicity at 3 months and quarterly thereafter. RESULTS: At initial clinical evaluation at 3 months 58% of the patients had a complete response as indicated by negative cystoscopy, bladder biopsy and urine cytology but in 42% treatment failed. At a mean followup of 12 months (range 9 to 48) 10 of the 21 complete responders had recurrence for an overall durable response rate of 31%. Fourteen patients subsequently underwent cystectomy for persistent carcinoma in situ (12) and carcinoma in situ recurrence (2). Of the 36 patients 7 experienced bladder contracture. CONCLUSIONS: The initial results are encouraging for a single whole bladder photodynamic treatment of patients in whom prior intravesical therapy for carcinoma in situ has failed. While followup is short, porfimer sodium photodynamic therapy appears potentially promising as an alternative to cystectomy in patients with refractory carcinoma in situ.

Adult↗
PubMed1997

Stage T1-2 prostate cancer with pretreatment prostate-specific antigen level < or = 10 ng/ml: radiation therapy or surgery?

PURPOSE: To detect differences in biochemical failure rates by treatment modality (radiation therapy or radical prostatectomy) in patients with early-stage prostate cancer presenting with pretreatment prostatic-specific antigen (PSA) levels < or = 10.0 ng/ml. METHODS AND MATERIALS: A total of 1467 consecutive patients with prostate carcinoma were treated with either radiotherapy (RT) or radical prostatectomy (RP) between January 1987 and June 1996. Patients with the following were excluded from the present study: initial PSA (iPSA) level > 10 ng/ml (n = 444), clinical Stage T3 disease (n = 73), adjuvant or neoadjuvant treatment (n = 173), no available iPSA level (n = 31), no available biopsy Gleason score (GS) (n = 33), incomplete pathologic information (n = 16), and no available follow-up PSA levels (n = 90). The analysis was performed on 607 cases: 354 treated with RP and 253 with RT (median dose 68.4 Gy). The outcome of interest was biochemical relapse-free survival (bRFS), with biochemical relapse being defined as either a detectable PSA level after RP or elevation in PSA levels of > or = 1.0 ng/ml above the nadir after RT. Proportional hazards were used to analyze the effect of treatment modality and confounding variables (i.e., age, stage, biopsy GS, iPSA levels) on treatment outcome. RESULTS: Seventy-nine percent of patients (n = 478) had clinical Stage T1 or T2A disease at presentation (RP vs. RT: 84% vs. 71%, p < 0.001). Twenty-one percent of patients (n = 127) had iPSA levels < or = 4 ng/ml (RP vs. RT: 24% vs. 17%, p = 0.027). Seventy-six percent of patients (n = 460) had biopsy GS < or = 6 (RP vs. RT: 79% vs. 71%, p = 0.014). The median follow-up time was 24 months (range 3-110). For the 607 patients, the 5-year bRFS rate was 76%. The 5-year RFS rates for RP versus RT were 76% versus 75%, respectively (p = 0.09). After adjustment for all confounding variables, iPSA levels (p < 0.001) and biopsy GS (p = 0.001) were the only independent predictors of relapse, whereas age, clinical stage, and treatment modality were not (p = 0.20; p = 0.09; and p = 0.10, respectively). CONCLUSION: In patients with clinical Stage T1-2 prostate cancer and pretreatment PSA < or = 10 ng/ml, there is no difference in biochemical failure rates between those treated with radiation and those treated with surgery.

Aged↗