Randomized Prospective Study Comparing Radical Prostatectomy Alone Versus Radical Prostatectomy Preceded by Androgen Blockage in Clinical Stage B2 (T2bNxM0) Prostate Cancer

Abstract

No AccessJournal of UrologyClinical Urology: Original Article1 Aug 1995Randomized Prospective Study Comparing Radical Prostatectomy Alone Versus Radical Prostatectomy Preceded by Androgen Blockage in Clinical Stage B2 (T2bNxM0) Prostate Cancer Mark S. Soloway, Roohollah Sharifi, Zev Wajsman, David McLeod, David P. Jr. Wood, and Antonio for the Lupron Depot Neoadjuvant Prostate Cancer Study Group* Puras-Baez Mark S. SolowayMark S. Soloway , Roohollah SharifiRoohollah Sharifi , Zev WajsmanZev Wajsman , David McLeodDavid McLeod , David P. Jr. WoodDavid P. Jr. Wood , and Antonio for the Lupron Depot Neoadjuvant Prostate Cancer Study Group* Puras-BaezAntonio for the Lupron Depot Neoadjuvant Prostate Cancer Study Group* Puras-Baez View All Author Informationhttps://doi.org/10.1016/S0022-5347(01)67067-8AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Nonrandomized clinical trials have suggested that preoperative androgen deprivation can decrease the likelihood of positive surgical margins in patients with clinically localized prostate cancer. A multicenter prospective randomized trial compared radical prostatectomy alone to radical prostatectomy after 3 months of leuprolide acetate depot and flutamide in patients with stage cT2bNxM0 prostate cancer and a serum prostate specific antigen level less than 50 ng./ml. Materials and Methods: We randomized 149 patients to undergo androgen deprivation and 138 to undergo lymphadenectomy with (137) or without (1) prostatectomy. Of the 154 patients randomized to the surgery alone group 144 underwent pelvic node dissection with (138) or without (6) prostatectomy. Results: There was no statistically significant difference between the 2 groups in operating time, blood loss, need for transfusion, postoperative morbidity or length of hospital stay. There were 4 rectal and 2 ureteral injuries in the surgery alone group and none in the pretreatment group (p less than 0.05). Patients who received androgen deprivation preoperatively had a significantly lower rate of capsule penetration (47 percent versus 78 percent, p less than 0.001), positive surgical margins (18 percent versus 48 percent, p less than 0.001) and tumor at the urethral margin (6 percent versus 17 percent, p less than 0.01). Conclusions: Long-term followup data will be needed to determine whether there will be a lower incidence of biochemical relapse as determined by prostate specific antigen, local recurrence or metastasis, with an improvement in patient survival. References 1 : The contemporary incidence of lymph node metastases in prostate cancer: implications for laparoscopic lymph node dissection. J. Urol.1993; 149: 1488. Link, Google Scholar 2 : Lower incidence of unsuspected lymph node metastases in 521 consecutive patients with clinically localized prostate cancer. J. Urol.1992; 147: 1574. Link, Google Scholar 3 : The use of prostate specific antigen, clinical stage and Gleason score to predict pathological stage in men with localized prostate cancer. J. Urol.1993; 150: 110. Link, Google Scholar 4 : Analysis of risk factors associated with prostate cancer extension to the surgical margin and pelvic node metastasis at radical prostatectomy. J. Urol.1993; 150: 1845. Link, Google Scholar 5 : Survival of men with clinically localized prostate cancer detected in the eighth decade of life. J. Urol.1994; 151: 1326. Abstract, Google Scholar 6 : Use of neoadjuvant androgen deprivation therapy in clinically localized prostate cancer. Clin. Invest. Med.1993; 16: 516. Google Scholar 7 : Selection of patients with stage B prostate cancer for radical prostatectomy. Urol. Clin. N. Amer.1990; 17: 779. Google Scholar 8 : The role of radical prostatectomy in the treatment of prostate cancer. CA1992; 42: 212. Google Scholar 9 : Is tumor volume an independent predictor of progression following radical prostatectomy? A multivariate analysis of 185 clinical stage B adenocarcinomas of the prostate with 5 years of followup. J. Urol.1993; 149: 1478. Link, Google Scholar 10 : Positive margins after radical prostatectomy: correlation with local recurrence and distant progression. Brit. J. Urol.1993; 72: 489. Crossref, Medline, Google Scholar 11 : Residual disease after radical surgery or radiation therapy for prostate cancer: clinical significance and therapeutic implications. Cancer1993; 71: 959. Google Scholar 12 : Combined hormone control therapy and radical prostatectomy in the treatment of selected cases of advanced carcinoma of the prostate: a restrospective study based upon 25 years of experience. J. Urol.1969; 101: 86. Abstract, Google Scholar 13 : Hormone ablation therapy as neoadjuvant treatment to radical prostatectomy. Clin. Invest. Med.1993; 16: 532. Google Scholar 14 : Neoadjuvant hormonal therapy in stage C adenocarcinoma of the prostate. Clin. Invest. Med.1993; 16: 510. Google Scholar 15 : Neoadjuvant hormonal deprivation before radical prostatectomy. Eur. urol.1993; 24: 46. Google Scholar 16 : Significance of androgen deprivation prior to radical prostatectomy, with special reference to prostate specific antigen. World. J. Urol.1993; 11: 221. Google Scholar 17 : Downstaging of localized prostate cancer by neoadjuvant therapy with flutamide and lupron: the first controlled and randomized trial. Clin. Invest. Med.1993; 16: 499. Google Scholar 18 : Clinical experience with leuprorelin acetate before radiotherapy for prostatic cancer. J. Int. Med. Res.1990; 18: 74. Google Scholar 19 : Complete androgen deprivation prior to radical prostatectomy in patients with stage T3 cancer of the prostate. Eur. Urol.1991; 19: 192. Crossref, Medline, Google Scholar 20 : Phase II Radiation Therapy Oncology Group study of hormonal cytoreduction with flutamide and Zoladex in locally advanced carcinoma of the prostate treated with definitive radiotherapy. Amer. J. Clin. Oncol.1990; 13: 461. Google Scholar 21 : Luteinizing hormone-releasing hormone downstaging of clinical stage C prostate cancer. J. Urol.1992; 147: 891. Abstract, Google Scholar 22 : Neoadjuvant hormonal deprivation in patients with locally advanced prostate cancer. J. Urol.1993; 150: 132. Link, Google Scholar 23 : Neoadjuvant hormonal treatment in clinical stage C prostate cancer. J. urol., part 21993; 149: 347A. abstract 539. Google Scholar 24 : Preoperative androgen deprivation therapy: artificial lowering of serum prostate specific antigen without downstaging the tumor. J. Urol.1993; 149: 779. Abstract, Google Scholar 25 : Influence of capsular penetration on progression following radical prostatectomy: a study of 196 cases with long-term followup. J. Urol.1993; 150: 135. Link, Google Scholar 26 : Influence of wide excision of the neurovascular bundle(s) on prognosis in men with clinically localized prostate cancer with established capsular penetration. J. urol.1993; 150: 142. Link, Google Scholar 27 : Leuprorelin acetate depot: results of a multicentre Japanese trial. TAP-144-SR Study Group. J. Int. Med. Res.1990; 18: 90. Google Scholar 28 : Multiple advantages of prior and post-radical prostatectomy with combined endocrine therapy. Eur Urol.1990; 18: 97. Google Scholar 29 : Histologic changes in prostate carcinomas treated with leuprolide (luteinizing hormone-releasing hormone effect): distinction from poor tumor differentiation. Cancer1994; 73: 1472. Google Scholar 30 : Pathologic changes associated with androgen deprivation therapy for prostate cancer. Cancer1991; 68: 821. Google Scholar 31 : Radical prostatectomy for clinical stage T1-2 NOMO prostatic adenocarcinoma: long-term results. J. Urol.1990; 144: 1180. Abstract, Google Scholar Department of Urology, University of Miami Medical School, Miami and University of Florida, Gainesville, Florida; University of illinois, Chicago, Illinois; Walter Reed Army Hospital, Washington, D. C.; University of Kentucky, Lexington, Kentucky, and University of Puerto Rico, Hato Rey, Puerto Rico.© 1995 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byTaneja S (2019) Re: Evaluation of Intense Androgen Deprivation before Prostatectomy: A Randomized Phase II Trial of Enzalutamide and Leuprolide with or without AbirateroneJournal of Urology, VOL. 202, NO. 4, (662-662), Online publication date: 1-Oct-2019.Womble P, VanVeldhuizen P, Nisbet A, Reed G, Thrasher J and Holzbeierlein J (2011) A Phase II Clinical Trial of Neoadjuvant Ketoconazole and Docetaxel Chemotherapy Before Radical Prostatectomy in High Risk PatientsJournal of Urology, VOL. 186, NO. 3, (882-888), Online publication date: 1-Sep-2011.Magera J, Inman B, Slezak J, Bagniewski S, Sebo T and Myers R (2007) Increased Optical Magnification From 2.5× to 4.3× With Technical Modification Lowers the Positive Margin Rate in Open Radical Retropubic ProstatectomyJournal of Urology, VOL. 179, NO. 1, (130-135), Online publication date: 1-Jan-2008.Carver B, Bianco F, Scardino P and Eastham J (2018) Long-Term Outcome Following Radical Prostatectomy in Men With Clinical Stage T3 Prostate CancerJournal of Urology, VOL. 176, NO. 2, (564-568), Online publication date: 1-Aug-2006.Maldonado-Valadez R, Teber D, Erdogru T, Safi K, Frede T and Rassweiler J (2018) The Impact of Neoadjuvant Hormonal Therapy on the Outcome of Laparoscopic Radical Prostatectomy: A Matched Pair AnalysisJournal of Urology, VOL. 175, NO. 6, (2092-2096), Online publication date: 1-Jun-2006.KONETY B, EASTHAM J, REUTER V, SCARDINO P, DONAT S, DALBAGNI G, RUSSO P, HERR H, SCHWARTZ L, KANTOFF P, SCHER H and KELLY W (2018) Feasibility of Radical Prostatectomy After Neoadjuvant Chemohormonal Therapy for Patients With High Risk or Locally Advanced Prostate Cancer: Results of a Phase I/II StudyJournal of Urology, VOL. 171, NO. 2, (709-713), Online publication date: 1-Feb-2004.MARTINEZ A, GALALAE R, GONZALEZ J, MITCHELL C, GUSTAFSON G and KOVACS G (2018) No Apparent Benefit at 5 Years From a Course of Neoadjuvant/Concurrent Androgen Deprivation for Patients With Prostate Cancer Treated With a High Total Radiation DoseJournal of Urology, VOL. 170, NO. 6, (2296-2301), Online publication date: 1-Dec-2003.Mouraviev V, Li L, Tahir S, Yang G, Timme T, Goltsov A, Ren C, Satoh T, Wheeler T, Ittmann M, Miles B, Amato R, Kadmon D and Thompson T (2018) The Role Of Caveolin-1 In Androgen Insensitive Prostate CancerJournal of Urology, VOL. 168, NO. 4 Part 1, (1589-1596), Online publication date: 1-Oct-2002.SOLOWAY M, PAREEK K, SHARIFI R, WAJSMAN Z, McLEOD D, WOOD D and PURAS-BAEZ A (2018) NEOADJUVANT ANDROGEN ABLATION BEFORE RADICAL PROSTATECTOMY IN cT2bNxMo PROSTATE CANCER: 5-YEAR RESULTSJournal of Urology, VOL. 167, NO. 1, (112-116), Online publication date: 1-Jan-2002.GLEAVE M, GOLDENBERG S, CHIN J, WARNER J, SAAD F, KLOTZ L, JEWETT M, KASSABIAN V, CHETNER M, DUPONT C and VAN RENSSELAER S (2018) RANDOMIZED COMPARATIVE STUDY OF 3 VERSUS 8-MONTH NEOADJUVANT HORMONAL THERAPY BEFORE RADICAL PROSTATECTOMY: BIOCHEMICAL AND PATHOLOGICAL EFFECTSJournal of Urology, VOL. 166, NO. 2, (500-507), Online publication date: 1-Aug-2001.SCOLIERI M, ALTMAN A and RESNICK M (2018) NEOADJUVANT HORMONAL ABLATIVE THERAPY BEFORE RADICAL PROSTATECTOMY: A REVIEW. IS IT INDICATED?Journal of Urology, VOL. 164, NO. 5, (1465-1472), Online publication date: 1-Nov-2000.MEYER F, MOORE L, BAIRATI I, LACOMBE L, TÊTU B and FRADET Y (2018) NEOADJUVANT HORMONAL THERAPY BEFORE RADICAL PROSTATECTOMY AND RISK OF PROSTATE SPECIFIC ANTIGEN FAILUREJournal of Urology, VOL. 162, NO. 6, (2024-2028), Online publication date: 1-Dec-1999.RABBANI F, PERROTTI M, BASTAR A and FAIR W (2018) PROSTATE SPECIFIC ANTIGEN DOUBLING TIME AFTER RADICAL PROSTATECTOMY: EFFECT OF NEOADJUVANT ANDROGEN DEPRIVATION THERAPYJournal of Urology, VOL. 161, NO. 3, (847-852), Online publication date: 1-Mar-1999.BONNEY W, SCHNED A and TIMBERLAKE D (2018) NEOADJUVANT ANDROGEN ABLATION FOR LOCALIZED PROSTATIC CANCER: PATHOLOGY METHODS, SURGICAL END POINTS AND META-ANALYSIS OF RANDOMIZED TRIALSJournal of Urology, VOL. 160, NO. 5, (1754-1760), Online publication date: 1-Nov-1998.RABBANI F, BASTAR A and FAIR W (2018) SITE SPECIFIC PREDICTORS OF POSITIVE MARGINS AT RADICAL PROSTATECTOMY: AN ARGUMENT FOR RISK BASED MODIFICATION OF TECHNIQUEJournal of Urology, VOL. 160, NO. 5, (1727-1733), Online publication date: 1-Nov-1998.OEFELEIN M (2018) TIME TO NORMALIZATION OF SERUM TESTOSTERONE AFTER 3-MONTH LUTEINIZING HORMONE-RELEASING HORMONE AGONIST ADMINISTERED IN THE NEOADJUVANT SETTING: IMPLICATIONS FOR DOSING SCHEDULE AND NEOADJUVANT STUDY CONSIDERATIONJournal of Urology, VOL. 160, NO. 5, (1685-1688), Online publication date: 1-Nov-1998.LITWIN M, PASTA D, STODDARD M, HENNING J and CARROLL P (2018) EPIDEMIOLOGICAL TRENDS AND FINANCIAL OUTCOMES IN RADICAL PROSTATECTOMY AMONG MEDICARE BENEFICIARIES, 1991 TO 1993Journal of Urology, VOL. 160, NO. 2, (445-448), Online publication date: 1-Aug-1998.WIEDER J and SOLOWAY M (2018) INCIDENCE, ETIOLOGY, LOCATION, PREVENTION AND TREATMENT OF POSITIVE SURGICAL MARGINS AFTER RADICAL PROSTATECTOMY FOR PROSTATE CANCERJournal of Urology, VOL. 160, NO. 2, (299-315), Online publication date: 1-Aug-1998.AUS G, ABRAHAMSSON P, AHLGREN G, HUGOSSON J, LUNDBERG S, SCHAIN M, SCHELIN S and PEDERSEN K (2018) HORMONAL TREATMENT BEFORE RADICAL PROSTATECTOMY: A 3-YEAR FOLLOWUPJournal of Urology, VOL. 159, NO. 6, (2013-2017), Online publication date: 1-Jun-1998.GARZOTTO M and WAJSMAN Z (2018) ANDROGEN DEPRIVATION WITH SALVAGE SURGERY FOR RADIORECURRENT PROSTATE CANCER: RESULTS AT 5-YEAR FOLLOWUPJournal of Urology, VOL. 159, NO. 3, (950-955), Online publication date: 1-Mar-1998.RABBANI F, GOLDENBERG S and KLOTZ L (2018) PREDICTORS OF PATHOLOGICAL STAGE BEFORE NEOADJUVANT ANDROGEN WITHDRAWAL THERAPY AND RADICAL PROSTATECTOMYJournal of Urology, VOL. 159, NO. 3, (925-928), Online publication date: 1-Mar-1998.Zhang S, Bentel J, Ricciardelli C, Horsfall D, Haagensen D, Marshall V and Tilley W (2018) IMMUNOLOCALIZATION OF APOLIPOPROTEIN D, ANDROGEN RECEPTOR AND PROSTATE SPECIFIC ANTIGEN IN EARLY STAGE PROSTATE CANCERSJournal of Urology, VOL. 159, NO. 2, (548-554), Online publication date: 1-Feb-1998.Vicini F, Horwitz E, Gonzalez J and Martinez A (2018) Treatment Options for Localized Prostate Cancer Based on Pretreatment Serum Prostate Specific Antigen LevelsJournal of Urology, VOL. 158, NO. 2, (319-325), Online publication date: 1-Aug-1997.Gleave M, Sato N, Goldenberg S, Stothers L, Bruchovsky N and Sullivan L (2018) Neoadjuvant Androgen Withdrawal Therapy Decreases Local Recurrence Rates Following Tumor Excision in the Shionogi Tumor ModelJournal of Urology, VOL. 157, NO. 5, (1727-1730), Online publication date: 1-May-1997.Goldenberg S, Klotz L, Srigley J, Jewett M, Mador D, Fradet Y, Barkin J, Chin J, Paquin J, Bullock M and Laplante S (2018) Randomized, Prospective, Controlled Study Comparing Radical Prostatectomy Alone and Neoadjuvant Androgen Withdrawal in the Treatment of Localized Prostate CancerJournal of Urology, VOL. 156, NO. 3, (873-877), Online publication date: 1-Sep-1996.Dalkin B, Ahmann F, Nagle R and Johnson C (2018) Randomized Study of Neoadjuvant Testicular Androgen Ablation Therapy Before Radical Prostatectomy in Men with Clinically Localized Prostate CancerJournal of Urology, VOL. 155, NO. 4, (1357-1360), Online publication date: 1-Apr-1996. Volume 154Issue 2August 1995Page: 424-428 Advertisement Copyright & Permissions© 1995 by American Urological Association, Inc.MetricsAuthor Information Mark S. Soloway More articles by this author Roohollah Sharifi More articles by this author Zev Wajsman More articles by this author David McLeod More articles by this author David P. Jr. Wood More articles by this author Antonio for the Lupron Depot Neoadjuvant Prostate Cancer Study Group* Puras-Baez More articles by this author Expand All Advertisement PDF downloadLoading ...