Radical Surgery Versus Radiotherapy for Adenocarcinoma of the Prostate

Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. In the United States, 90% of men with prostate cancer are more than age 60 years, diagnosed by early detection with the prostatespecific antigen (PSA) blood test, and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting (WW), surgery to remove the prostate gland (radical prostatectomy), external-beam radiation therapy and interstitial radiation therapy (brachytherapy), and androgen deprivation. Little is known about the relative effectiveness and harms of treatments because of the paucity of randomized controlled trials. The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy with WW in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods, and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy vs WW conducted in Scandinavia. We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8 ng/mL (mean 10.2 ng/mL). In three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk categorizations incorporating PSA levels, Gleason histologic grade, and tumor stage, it was found that approximately 40% had low-risk, 34% had medium-risk, and 21% had high-risk prostate cancer based on local histopathology. Comparison to our national sample of eligible men declining PIVOT participation as well as to men enrolled in the Scandinavian trial indicated that PIVOT enrollees are representative of men being diagnosed and treated in the United States and quite different from men in the Scandinavian trial. PIVOT enrolled an ethnically diverse population representative of men diagnosed with prostate cancer in the United States. Results will yield important information regarding the relative effectiveness and harms of surgery compared with WW for men with predominately PSA-detected clinically localized prostate cancer.

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“…The three RCTs comparing surgery with WW or radiation therapy were conducted before prostate cancer detection with PSA testing (6)(7)(8).…”

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The Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): Design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer

Wilt¹,

Brawer²,

Barry³

et al. 2009

Contemporary Clinical Trials

161

125

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“…To our knowledge, to date there are no published large, prospective, randomized trials comparing radical prostatectomy (RP) with external beam radiation therapy (RT) for the treatment of prostate carcinoma during the prostate specific antigen (PSA) era. A single randomized study was performed in the pre-PSA era 1 ; however, the results of the study were inconclusive due to imbalances in the health, age, and lymph node assessment of the patients in the two treatment groups. 2 The utility of the pretreatment PSA level, 3 biopsy Gleason score, 4 percent positive prostate biopsies, and the 1992 American Joint Commission on Cancer (AJCC) staging T category 5 in predicting postradiation [6][7][8] and postoperative 7,[9][10][11] PSA outcome has been well described previously.…”

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Biochemical outcome after radical prostatectomy or external beam radiation therapy for patients with clinically localized prostate carcinoma in the prostate specific antigen era

D’Amico

Whittington

Malkowicz

et al. 2002

Cancer

317

170

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BACKGROUNDTo the authors' knowledge, consensus is lacking regarding the relative long‐term efficacy of radical prostatectomy (RP) versus conventional‐dose external beam radiation therapy (RT) in the treatment of patients with clinically localized prostate carcinoma.METHODSA retrospective cohort study of 2635 men treated with RP (n = 2254) or conventional‐dose RT (n = 381) between 1988–2000 was performed. The primary endpoint was prostate specific antigen (PSA) survival stratified by treatment received and high‐risk, intermediate‐risk, or low‐risk group based on the serum PSA level, biopsy Gleason score, 1992 American Joint Commission on Cancer clinical tumor category, and percent positive prostate biopsies.RESULTSEstimates of 8‐year PSA survival (95% confidence interval [95% CI]) for low‐risk patients (T1c,T2a, a PSA level ≤ 10 ng/mL, and a Gleason score ≤ 6) were 88% (95% CI, 85, 90) versus 78% (95% CI, 72, 83) for RP versus patients treated with RT, respectively. Eight‐year estimates of PSA survival also favored RP for intermediate‐risk patients (T2b or Gleason score 7 or a PSA level > 10 and ≤ 20 ng/mL) with < 34% positive prostate biopsies, being 79% (95% CI, 73, 85) versus 65% (95% CI, 58, 72), respectively. Estimates of PSA survival in high‐risk (T2c or PSA level > 20 ng/mL or Gleason score ≥ 8) and intermediate‐risk patients with at least 34% positive prostate biopsies initially favored RT, but were not significantly different after 8 years.CONCLUSIONSIntermediate‐risk and low‐risk patients with a low biopsy tumor volume who were treated with RP appeared to fare significantly better compared with patients who were treated using conventional‐dose RT. Intermediate‐risk and high‐risk patients with a high biopsy tumor volume who were treated with RP or RT had long‐term estimates of PSA survival that were not found to be significantly different. [See editorials on pages 211–4 and 215–8, this issue. Cancer 2002;95:281–6. © 2002 American Cancer Society.DOI 10.1002/cncr.10657

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“…Paulson et al [11] found a 5-year survival value of 90% for patients with stages T l b and T2 disease after radical prostatectomy, Approximately 85% of patients with lymphatic spread of prostatic carcinoma develop distant metastases within 5 years, and the vast majority of these die within 3 years thereafter. Of patients with stage D2 disease, about 50% die of prostate cancer within 30 months, 80% die within 5 years, and 90% succumb within 10 years [3].…”

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Efficient pathway for early detection of prostate cancer concluded from a 5-year prospective study

et al. 1993

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Summary. In a prospective study the statistical characteristics of digital rectal examination (DRE), transrectal ultrasound (TRUS), and serologic determination of prostate-specific antigen (PSA) were assessed in 1230 patients aged over 40 years. The sensitivity, specificity, and positive and negative predictive values were determined to be 80. 3%, 69.7o70, 58.9o70, and 86.7o70, respectively, for DRE; 76.5o7o, 62.3o70, 52.3°7o, and 83.1%, respectively, for TRUS; and 87.9%, 49.6%, 48.5O7o, and 88.3%, respectively, for PSA (normal level, 4 ng/ml). The data clearly demonstrate the nonsuitability of each single measure for reliable early detection of prostatic carcinoma. Connection of the parameters in all possible combinations under various conditions demonstrated the superiority of the test "DRE and PSA > 4 ng/ml" over DRE as the "gold standard" and all other options. The use of this approach as the first-line raster of an algorithm (outlined herein) would allow the detection of prostatic malignancy with a specificity of 86.5% and a positive predictive value of 74.0°7o. Supplementing this screen with short-term controls in cases in which only one parameter is positive ("DRE or PSA > 4 ng/ml") might enable the detection of almost all patients with prostate cancer. TRUS did not provide any additional information.The principle that early diagnosis of most human malignancies enables detection of cancer at a lower and, by definition, more curable stage applies as well for prostate cancer [7]. According to a survey of the American College of Surgeons in 1986 [14], transurethral resection has been the most common means to establish the diagnosis of prostatic neoplasms. Over the last decade, how-*Acknowledged with the Cancer Award of the State of Lower Saxony, Germany, I992.Correspondence to: Prof. Dr. E.P. Allhoff, Department of Urology, Hannover Medical School, Konstanty-Gutschow-Strasse 8, D-30625 Hannover, Germany ever, the diagnostic approach to prostate cancer has been enriched by the availability of new immunoserologic as well as imaging modalities for routine clinical use. The advances achieved in these fields prompted us in 1987 to evaluate these modalities with respect to their capacity for detecting prostate cancer either alone or in combination and to compare the results with the findings obtained by digital rectal examination (DRE), which at that time was considered the "gold standard". Patients and methodsIn an ongoing prospective study, 1230 men over 40 years of age recruited from the total-patients cohort at our institution were investigated for the potential presence of a prostatic malignancy by clinical, immunochemical, and sonographic means.Prior to digital rectal examination (DRE), determination of the serum level of prostate-specific antigen (PSA) was performed using initially an immunoradiometric assay and later an immunoenzymatic assay employing monoclonal antibodies (Hybritech, Inc.). According to the recommendation by the manufacturer, the normal reference interval was defined as 0 -3.9 ng/ml. D...

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Radical Surgery Versus Radiotherapy for Adenocarcinoma of the Prostate

Cited by 346 publications

References 12 publications

The Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): Design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer

The Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): Design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer

Biochemical outcome after radical prostatectomy or external beam radiation therapy for patients with clinically localized prostate carcinoma in the prostate specific antigen era

Efficient pathway for early detection of prostate cancer concluded from a 5-year prospective study

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