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Clinical Trials in Prostatic Cancer: Methodology and Controversies

  • Chapter
Adenocarcinoma of the Prostate

Part of the book series: Clinical Practice in Urology ((PRACTICE UROLOG))

Abstract

Prostatic cancer is a heterogeneous disorder with varying biologic potential. The prevalence of asymptomatic disease in up to 28% of autopsy series has led some to consider this an innocuous disease of the elderly (Breslow et al. 1977; Mettlin 1983). However, despite new biologic markers (Guinan 1981; Pontes 1983; Zweig and Ihde 1985), the proportion of patients with stages C and D at diagnosis has not changed (Slack et al. 1986) and the annual death rate has remained constant (Silverberg 1985). Although new hormonal therapies have recently been introduced (Trachtenberg 1984; Drago et al. 1985; Labrie et al. 1985; Eisenberg et al. 1986), no consistent improvement in response rate, response duration, or survival has been observed. More disturbing is a recent analysis showing an increase in the proportion of deaths attributable to prostatic cancer for patients diagnosed from 1980 to 1983 (Slack et al. 1986). Clearly, new therapeutic modalities are needed.

Dr Scher is the recipient of an American Cancer Society Clinical Oncology Career Development Award.

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References

  • Anderson JR, Cain KC, Gelber RD (1983) Analysis of survival by tumor response. J Clin Oncol 1: 710–719

    PubMed  CAS  Google Scholar 

  • Bayard S, Greenberg R, Showmutter D et al. (1974) Comparison of treatments for prostatic cancer using an exponential life table model relating survival to concomitant information. Cancer Chemother Rep 58: 845–859

    PubMed  CAS  Google Scholar 

  • Benson M, McDougal D, Coffey DS (1984) The use of multiparametric flow cytometry to assess tumor cell heterogeneity and grade metastatic prostate cancer. Prostate 5: 27–45

    PubMed  CAS  Google Scholar 

  • Birch A, Irwin L, Troner M et al. (1985) Diethylstilbesterol (DES) vs. cyclophosphamide (C) + DES as initial therapy for metastatic prostatic carcinoma. A Southeastern Cancer Study Group Trial. Proc Am Soc Clin Oncol 4: 98

    Google Scholar 

  • Bishop M, Fellows G (1977) Urinary hydroxyproline excretion—a marker of bone metastases in prostate carcinoma. Br J Urol 49: 711–718

    PubMed  CAS  Google Scholar 

  • Bragg D (1984) Advances in tumor imaging. Hosp Pract 19: 83

    CAS  Google Scholar 

  • Brenckman W, Lastinger L, Sedor F (1981) Unpredictable fluctuations in serum acid phosphatase activity in prostatic cancer. JAMA 245: 2501–2504

    PubMed  Google Scholar 

  • Breslow N, Chan CW, Thorm G et al. (1977) Latent carcinoma of the prostate at autopsy in seven areas. Int J Cancer 20: 680–688

    PubMed  CAS  Google Scholar 

  • Bruce AW, Mahan DE (1982) The role of prostatic acid phosphatase in the investigation and treatment of adenocarcinoma of the prostate. Ann NY Acad Sci 390: 110–113

    PubMed  CAS  Google Scholar 

  • Bulbul M, Heston WDW, Mirenda C, Fair W (1986) A prostate-derived growth factor partially purified by heparin affinity and anion exchange chromatography (abstr). Proc Am Assoc Cancer Res 27: 852

    Google Scholar 

  • Buonocore E, Hasemann C, Pavlicek W, Montie J (1984) Clinical and in vitro magnetic resonance imaging of prostatic carcinoma. AJR 143: 1267–1272

    PubMed  CAS  Google Scholar 

  • Capizzi R, Keiser W, Sartorelli A (1977) Combination chemotherapy—theory and practice. Semin Oncol 4: 227–253

    PubMed  CAS  Google Scholar 

  • Chisholm GD, O’Donoghue EPN, Kennedy CL (1977) The treatment of estrogen-resistant stage D carcinoma of the prostate with estramustine phosphate. Br J Urol 49: 717–720

    PubMed  CAS  Google Scholar 

  • Citrin D, Cohen A, Harberg J et al. (1981) Systemic treatment of advanced prostatic cancer: development of a new system for defining response. J Urol 125: 224–228

    PubMed  CAS  Google Scholar 

  • Citrin DL, Elson P, DeWys W (1984) Treatment of metastatic prostate cancer: an analysis of response criteria in patients with measurable soft tissue disease. Cancer 54: 13–17

    PubMed  CAS  Google Scholar 

  • Coleman RE, Whitaker KB, Mashiter G et al. (1986) Assessment of osteoblast activity predicts radiological response in bone metastases from breast cancer (abstr). Proc Am Assoc Cancer Res 27: 180

    Google Scholar 

  • Condon BR, Buchanan R, Garvle NW et al. (1981) Assessment of progression of secondary bone lesions following cancer of the breast or prostate using serial radionuclide imaging. Br J Radiol 54: 18–23

    PubMed  CAS  Google Scholar 

  • Constable AR, Cranage RW (1981) Recognition of the superscan in prostatic bone scintigraphy. Br J Radiol 54: 122–125

    PubMed  CAS  Google Scholar 

  • Dahnert WF, Hamper UM, Eggleston J et al. (1986) Prostatic evaluation by transrectal sonography with histopathologic correlation: the echopenia appearance of early carcinoma. Radiology 158: 97–102

    PubMed  CAS  Google Scholar 

  • Deftos LJ, Parthemore JG, Price PA (1982) Changes in plasma bone GLA protein during treatment of bone disease. Calcif Tissue Int 34: 121–124

    PubMed  CAS  Google Scholar 

  • Dequecker J, Mbuyi-Muamba JM, Holvoet G (1983) Hydroxyproline and bone metastasis. In: Stoll BA, Parbhoo S (eds) Bone metastasis: monitoring and treatment. Raven Press, New York, pp 181–199

    Google Scholar 

  • DeWys WD, Begg CB, Brodowsky H et al. (1983) A comparative clinical trial of adriamycin and 5- fluorouracil in advanced prostatic cancer: prognostic factors and response. Prostate 4: 1–11.

    PubMed  CAS  Google Scholar 

  • Dexeus F, Logothetis C, Hossan R et al. (1984) Phase II study of vinblastine (Vlb) in advanced hormone resistant metastatic prostate cancer ( HPC ). Proc Am Soc Clin Oncol 3: 161

    Google Scholar 

  • Drago JR, Santen RJ, Lipton A et al. (1985) Clinical effect of aminoglutethimide, medical adrenalectomy, in treatment of 43 patients with advanced prostatic carcinoma. Cancer 53: 1447–1450

    Google Scholar 

  • Eagen RT, Hahn RG, Myers RR (1976) Adriamycin (NSC-123127) vérsus 5-fluorouracil (NSC- 19893) and cyclophosphamide (NSC-26271) in the treatment of metastatic prostate cancer. Cancer Treat Rep 60: 115–117

    Google Scholar 

  • Eisenberger M, Simon R, O’Dwyer P, Wittes R, Friedman M (1985) A reevaluation of nonhormonal cytotoxic chemotherapy in the treatment of prostatic carcinoma. J Clin Oncol 3: 827–841

    PubMed  CAS  Google Scholar 

  • Eisenberger MA, O’Dwyer PJ, Friedman MA (1986) Gonadotropin hormone-releasing hormone analogues: a new therapeutic approach for prostatic carcinoma. J Clin Oncol 4: 414–424

    PubMed  CAS  Google Scholar 

  • Ekman P, Svennerus K, Zetterberg A et al. (1981) Cytophotometric analysis and steroid receptor content in human prostatic carcinoma. Scand J Urol Nephrol [Suppl] 60: 85–88

    Google Scholar 

  • Elder JS, Gibbons RP (1985) Results of trials of the USA National Prostatic Cancer Project. Schroeder F, Richards B (eds) Therapeutic principles in metastatic prostatic cancer. Alan R. Liss, Inc., New York pp 221–242 (EORTC Genitourinary Group Monograph 2, part A)

    Google Scholar 

  • Emrich L, Priore R, Murphy GP et al. (1985) Prognostic factors in patients with advanced stage prostate cancer. Cancer Res 45: 5173–5179

    PubMed  CAS  Google Scholar 

  • English HF, Drago JR, Santen RJ (1986a) Cellular response to androgen depletion and repletion in the rat ventral prostate: autoradiography and morphometric analysis. Prostate 7: 41–51.

    Google Scholar 

  • English HF, Kloszewski E, Valentine E, Santen RJ (1986b) Proliferative response of the Dunning R3327H experimental model of prostatic adenocarcinoma to conditions of androgen depletion and repletion. Cancer Res 46: 839–844

    PubMed  CAS  Google Scholar 

  • Epstein S, Poser J, McClintock R, Johnston C, Bryce G, Hui S (1984) Differences in serum bone GLA protein with age and sex. Lancet 1: 307–310

    PubMed  CAS  Google Scholar 

  • Erol D, Adalar N, Guvencli S, Simsek F (1983) Urinary hydroxyproline levels in patients with prostatic carcinoma. Int Urol Nephrol 15: 267–274

    PubMed  CAS  Google Scholar 

  • Fleming I (1982) One sample multiple testing procedures for phase II clinical trials. Biometrics 38: 143–151

    PubMed  CAS  Google Scholar 

  • Fogelman I (1980) Skeletal uptake of diphosphate: a review. Eur J Nucl Med 5: 473–476

    PubMed  CAS  Google Scholar 

  • Fowler JE, Whitmore EF (1982) Considerations for the use of testosterone with systemic chemotherapy in prostatic cancer. Cancer 49: 1373–1377

    PubMed  Google Scholar 

  • Freiha FS, Lum BL, Spaulding J et al. (1985) Does response to chemotherapy in patients with bidimensional prostate metastases reflect tumor response in skeletal metastases? Proc Am Soc Clin Oncol 4: 102

    Google Scholar 

  • Galasko CSB (1975) The pathological basis for skeletal scintigraphy. J Bone Joint Surg 578: 353–359

    Google Scholar 

  • Gehan E (1961) The determination of the number of patients required in a follow up trial of a new chemotherapeutic agent. J Chron Dis 13: 346–353

    PubMed  CAS  Google Scholar 

  • Geller J, Albert J (1985) DHT in prostate cancer tissue—a guide to management and therapy. Prostate 6: 19–25

    PubMed  CAS  Google Scholar 

  • Gibbons RP, Beckley S, Brady MF et al. (1983) The addition of chemotherapy to hormonal therapy for treatment of patients with metastatic carcinoma of the prostate. J Surg Oncol 23: 133–142

    PubMed  CAS  Google Scholar 

  • Glatstein E, Makuch R (1984) Illusion and reality: practical pitfalls in interpreting clinical trials. J Clin Oncol 2: 488–497

    PubMed  CAS  Google Scholar 

  • Glode L, Max D et al. Leoprolide (1983) (D-Leu6-DesGly10-Pro9-NH Et-LHRH) in the therapy of advanced prostatic carcinoma. 13th Int Cong Chemotherapy 12.1.8.A Section 242: 49–52

    Google Scholar 

  • Groot C, Blak J (1984) Electron microscopical demonstration of osteocalcin antigenicity in fetal rat bone. Am Soc Bone Mineral Res 6: 12

    Google Scholar 

  • Guinan P (1981) What is the best test to detect prostate cancer? CA 141–146

    Google Scholar 

  • Gundberg CM, Lian JB, Gallop PM, Steinberg JJ (1983) Urinary gamma-carboxyglutamic acid and serum osteocalcin as bone markers: studies in osteoporosis and Paget’s disease. J Clin Endocrinol Metab 57: 1221–1225

    PubMed  CAS  Google Scholar 

  • Harper ME, Pierrepoint CG, Griffiths K (1984) Carcinoma of the prostate: relationship of pretreatment hormone levels to survival. Eur J Cancer Clin Oncol 20: 477–482

    PubMed  CAS  Google Scholar 

  • Heller W, Harzmann R, Bickler R, Schmidt K (1979) Urinary hydroxyproline in healthy patients and in patients with and without bone metastases. Curr Probl Clin Biochem 9: 249–258

    PubMed  CAS  Google Scholar 

  • Herr H, Kleinert E, Relyea N, Whitmore W (1984) Potentiation of methylglyoxal bisguanylhydrazone by alpha-difluromethylornithine in rat prostate cancer. Cancer 53: 1294–1298

    PubMed  CAS  Google Scholar 

  • Hopkins S, Nissenkorn I, Palmieri G et al. (1983) Serial spot hydroxyproline/creatinine ratios in metastatic prostatic cancer. J Urol 129: 319–323

    PubMed  CAS  Google Scholar 

  • Hopkins S, Palmieri G, Niell H et al. (1984) Total and nondialyzable hydroxyproline excretion in stage D2 prostate cancer. Cancer 53: 117–121

    PubMed  CAS  Google Scholar 

  • Hsu DS, Babaian RJ (1983) 5-Fluorouracil, Adriamycin, mitomycin-C ( FAM) in the treatment of hormonal-resistant stage D adenocarcinoma of the prostate (abstr ). Proc Am Soc Clin Oncol 2: 133

    Google Scholar 

  • Ihde D, Bunn PA, Cohen MH et al. (1980) Effective treatment of hormonally-unresponsive metastatic carcinoma of the prostate with adriamycin and cyclophosphamide: methods of documenting tumor response and progression. Cancer 45: 1300–1310

    PubMed  CAS  Google Scholar 

  • Ihde DC, Bunn PA, Cohen MH et al. (1981) Combination chemotherapy as initial treatment for stage D-2 prostatic cancer: response rate and results of subsequent hormonal therapy. Proc Am Assoc Cancer Res 22: 163

    Google Scholar 

  • Ihde DC, Belville WD, Mahan DE et al. (1982) Serum acid phosphatase in the assessment of response to systemic therapy in metastatic prostate cancer: comparison of radioimmune and enzymatic assays. Milit Med 147: 949–952

    CAS  Google Scholar 

  • Isaacs JT (1985) New principles in the management of metastatic prostatic cancer. Schroeder F, Richards B (eds) Therapeutic principles in metastatic prostatic cancer. Alan R. Liss, New York, pp 383–405 (EORTC Genitourinary Group Monograph 2, part A)

    Google Scholar 

  • Isaacs JT, Coffey DS (1982) Adaptation vs. selection as the mechanism responsible for the relapse of prostatic cancer to androgen therapy as studied in the Dunning R-3327-H adenocarcinoma. Cancer Res 42: 2353–2361

    PubMed  CAS  Google Scholar 

  • Jacobs S (1983) Spread of prostatic cancer to bone. Urology 21: 337–342

    PubMed  CAS  Google Scholar 

  • Jones WG, Members of the EORTC GU Group (1985) EORTC Phase II chemotherapy studies in prostate cancer. Schroeder F, Richards B (eds) Therapeutic principles in metastatic prostatic cancer. Alan R. Liss, New York, pp 435–447 (EORTC Genitourinary Group Monograph 2, part A)

    Google Scholar 

  • Kaplan LA, Chen IW, Sperling M, Bracken B, Stein E (1985) Clinical utility of serum prostatic acid phosphatase measurements for detection (screening), diagnosis, and therapeutic monitoring of prostatic carcinoma; assessment of monoclonal and polyclonal enzymes and radioimmunoassays. Am J Clin Pathol 84: 334–339

    PubMed  CAS  Google Scholar 

  • Kasimis B, Miller B, Kaneshiro C et al. (1985) Cyclophosphamide versus 5-fluorouracil, doxorubicin, and mitomycin C (FAM’) in the treatment of hormone resistant metastatic carcinoma of the prostate: a preliminary report of a randomized trial. J Clin Oncol 3: 385–392

    PubMed  CAS  Google Scholar 

  • Khansur T, Yam L, Tavassoli M (1983) Serum monitors of bone metastasis. In: Stoll BA, Parbhoo S (eds) Bone metastasis: monitoring and treatment. Raven Press, New York, pp 165–181

    Google Scholar 

  • Killian C, Yuang N, Emrich L et al. (1985) Prognostic importance of prostate-specific antigen for monitoring patients with stages B2 to D1 prostate cancer. Cancer Res 45: 886–891

    PubMed  CAS  Google Scholar 

  • Killian C, Emrich L, Vargas, F et al. (1986) Relative reliability of five serially measured markers for prognosis of progression in prostate cancer. J Natl Cancer Inst 76: 179–185

    PubMed  CAS  Google Scholar 

  • Kuriyama M, Wang MC, Lee CI et al. (1982) Multiple marker evaluation in prostate cancer using tissue specific antigens. J Natl Cancer Inst 68: 99–105

    PubMed  CAS  Google Scholar 

  • Labrie F, Dupont A, Belanger A (1985) Complete androgen blockade for treatment of prostate cancer. In: DeVita VT, Hellman S, Rosenberg SA (eds) Important advances in oncology. J.P. Lippincott, Philadelphia, pp 193–217

    Google Scholar 

  • Langhammer K, Sintermann R, Hor G, Pabst HW (1978) Serial bone scintigraphy for assessing the effectiveness of treatment of osseous metastases from prostatic cancer. Nucl Med 17: 87–91

    CAS  Google Scholar 

  • Levenson RM, Sauerbrunn BJL, Bates HR et al. (1983) Comparative value of bone scintigraphy and radiography in monitoring tumor response in systemically treated prostatic carcinoma. Radiology 146: 513–518

    PubMed  CAS  Google Scholar 

  • Lewenhaupt A, Ekman P, Eneroth P (1985) Tissue polypeptide antigen ( TPA) as a prognostic aid in human prostatic carcinoma. Prostate 6: 285–291

    PubMed  CAS  Google Scholar 

  • Loening SA, Scott WW, Dekernion J et al. (1981) A comparison of hydroxyurea, methyl- chloroethyl-chlorohexyl-nitrosourea and cyclophosphamide in patients with advanced prostate cancer. J Urol 125: 812–816

    PubMed  CAS  Google Scholar 

  • Logothetis CJ, von Eschenbach AC, Samuels ML et al. (1982) Doxorubicin, mitomycin and 5- fluorouracil (DMF) in the treatment of hormone-resistant stage D prostate cancer. A preliminary report. Cancer Treat Rep 66: 57–63

    CAS  Google Scholar 

  • Logothetis CJ, Samuels ML, von Eschenbach AC et al. (1983) Doxorubicin, mitomycin-C, and 5- fluorouracil ( DMF) in the treatment of metastatic hormonal refractory adenocarcinoma of the prostate, with a note on staging of metastatic prostate cancer. J Clin Oncol 1: 368–37

    PubMed  CAS  Google Scholar 

  • Lowenthal D, Scher H, Geller N et al. (1986) Osteocalcin (OC) as a marker of bone turnover in prostatic cancer ( PC) (abstr ). Proc Am Assoc Cancer Res 27: 160

    Google Scholar 

  • Manni A, Santen R, Boucher A et al. (1986) Androgen priming and response to chemotherapy in advanced prostate cancer (abstr). Proc Am Soc Clin Oncol 5: 96

    Google Scholar 

  • Mantel N, Byar DP (1974) Evaluation of response-time data involving transient states: an illustration using heart-transplant data. JASA 69: 81–91

    Google Scholar 

  • Markowitz M, Gundberg C, Rosen J (1984) 24 hour fluctuations in serum osteocalcin concentration in women. Am Soc Bone Mineral Res 6: 17

    Google Scholar 

  • Mee AD, Khan O, Mashiter K (1984) High serum prolactin associated with poor prognosis in carcinoma of the prostate. Br J Urol 56: 698–701

    PubMed  CAS  Google Scholar 

  • Mettlin C (1983) Epidemiology of prostate cancer in different population groups. Clin Oncol 2: 187–192

    Google Scholar 

  • Meyhoff HH, Ingemann L, Nordling J, Hald T (1981) Accuracy in preoperative estimation of prostatic size. Scand J Urol Nephrol 15: 45–51

    PubMed  CAS  Google Scholar 

  • Mittal R, Korval C, Starzl T et al. (1983) Accuracy of computerized tomography (CT) in determining hepatic tumor size in patients ( PTS) receiving liver transplants or resection. Proc Am Soc Clin Oncol 2: 121

    Google Scholar 

  • Moertel C, Hanley J (1976) The effect of measuring error on the results of therapeutic trials in advanced cancer. Cancer 38: 388–394

    PubMed  CAS  Google Scholar 

  • Moopan M, Wax S, Kim H et al. (1980) Urinary hydroxyproline excretion as a marker of osseous metastasis in carcinoma of the prostate. J Urol 123: 694–696

    Google Scholar 

  • Mooppan U, Kim H, Wang J, Tobin M, Wax S (1983) Use of urinary hydroxyproline excretion as a tumor marker in diagnosis and follow-up of prostate cancer. Prostate 4: 397–402

    Google Scholar 

  • Moore MR, Graham SO, Birch R, Irwin L (1987) Phase II evaluation of mitoguazone in metastatic hormone resistant prostate cancer: a Southeastern Cancer Group study trial. Cancer Treat Rep 71: 89–90

    PubMed  CAS  Google Scholar 

  • Mundy A (1979) Urinary hydroxyproline excretion in carcinoma of the prostate. A comparison of 4 different modes of assessment and its role as a marker. Br J Urol 51: 570–579

    PubMed  CAS  Google Scholar 

  • Nagel R, Borgmann V, Al-Ahabi H et al. (1983) Premiers resultats cliniques concernant le traitement du cancer de la prostate a un stade local avance au moyen d’un puissant analogue de la LHRH: l’acetate de busereline. J Urol 89: 669–676

    CAS  Google Scholar 

  • Nesbit RM, Baum WC (1950) Endocrine control of prostatic carcinoma: clinical and statistical survey of 1818 cases. JAMA 143: 1317–1320

    CAS  Google Scholar 

  • Nissenkorn I, Mickey D, Miller D et al. (1982) Circadian and day to day variation of prostatic acid phosphatase. J Urol 128: 1122–1124

    Google Scholar 

  • O’Bryan RM, Baker LH, Gorttleib JF et al. (1977) Dose response evaluation of Adriamycin in human neoplasia. Cancer 39: 1940–1948

    PubMed  Google Scholar 

  • Pabst HW, Langhammer H, Bauer R (1983) Technical problems in assessing bone scans. In: Stoll BA, Parbhoo S (eds) Bone metastasis: monitoring and treatment. Raven Press, New York, pp 85–106

    Google Scholar 

  • Page JP, Levi JA, Woods RL et al. (1985) Randomized trial of combination chemotherapy in hormone resistant metastatic prostatic carcinoma. Cancer Treat Rep 69: 105–107

    PubMed  CAS  Google Scholar 

  • Pappas A, Gadsden RH (1984) Prostatic acid phosphatase: clinical utility in detection, assessment, and monitoring carcinoma of the prostate. Ann Clin Lab Sci 14: 285–291

    PubMed  CAS  Google Scholar 

  • Parbhoo S (1983) Serial scintiscans in monitoring patients with bone metastasis. In: Stoll BA, Parbhoo S (eds) Bone metastasis: monitoring and treatment. Raven Press, New York, pp 201–237

    Google Scholar 

  • Paulsen D, Berry W, Cox E et al. (1979) Treatment of metastatic endocrine unresponsive carcinoma of the prostate gland with multi-agent chemotherapy: indicators of response to treatment. J Natl Cancer Inst 63: 615–622

    Google Scholar 

  • Peto R, Pike MC, Armitage NE et al. (1977) Design and analysis of randomized clinical trials requiring prolonged observation of each patient. Part II. Analysis and examples. Br J Cancer 35: 1–39

    CAS  Google Scholar 

  • Pollard M, Luckert PH (1985) Prostate cancer in a Sprague-Dawley rat. Prostate 6: 389–393

    PubMed  CAS  Google Scholar 

  • Pollen J, Gerber K, Ashbum W et al. (1981) The value of nuclear bone imaging in advanced prostatic cancer. J Urol 125: 222–223

    PubMed  CAS  Google Scholar 

  • Pollen JJ, Reznek R, Tolner LB (1984a) Lysis of osteoblastic lesions in prostatic cancer: a sign of progression. AJR 142:1175–1177 Pollen JJ, Witztum K, Ashburn WL (1984b) The flare phenomenon on radionuclide bone scan in metastatic prostatic cancer. AJR 142: 773–776

    PubMed  CAS  Google Scholar 

  • Pontes JE (1983) Biological markers in prostate cancer. J Urol 130: 1037–1047

    PubMed  CAS  Google Scholar 

  • Pontes JE, Chu TM, Slack N et al. (1978) Serum prostatic antigen measurement in localized prostatic cancer: correlation with clinical course. J Urol 128: 1216–1218

    Google Scholar 

  • Pretlow TG, Harris BE, Bradley EC et al. (1985) Enzyme activities in prostatic carcinoma related to Gleason grades. Cancer Res 45: 442–446

    PubMed  Google Scholar 

  • Price P, Otsuka A, Poser J, Kristaponis J, Raman N (1975) Characterization of a gamma- carboxyglutamic acid-containing protein from bone. Proc Natl Acad Sci 5: 1447–1451

    Google Scholar 

  • Queich K, Cole W, Melick R (1984) Noncollagenous proteins in normal and pathological human bone. Calcif Tissue Int 36: 454–462

    Google Scholar 

  • Richards B (1984) Clinical significance and statistical significance. In: Denis L, Murphy GP, Prout GR, Schroeder F (eds) Controlled clinical trials in urology. Raven Press, New York, pp 17–18

    Google Scholar 

  • Rifkin MD, Friedland GW, Shortliffe L (1986) Prostatic evaluation by transrectal endosonography: detection of carcinoma. Radiology 158: 85–90

    PubMed  CAS  Google Scholar 

  • Rinsho K, Aoyagi K (1982) Urinary hydroxyproline excretion as a marker of bone metastases in prostatic cancer. Tohoku J Exp Med 137: 461–467

    PubMed  CAS  Google Scholar 

  • Saiers JH, Trannum BL, Stephens R, Crawford ED (1985) Treatment of stage Dil adenocarcinoma of the prostate with doxorubicin, mitomycin C and 5-fluorouracil (DMF): a Southwest Oncology Group study. Proc Am Soc Clin Oncol 4: 108

    Google Scholar 

  • Saitoh H, Hida M, Shimbo T et al. (1984) Metastatic patterns of prostatic cancer: correlation between sites and number of organs involved. Cancer 54: 3078–3084

    PubMed  CAS  Google Scholar 

  • Sandhu RS, Conover RE (1980) Usually high creatine kinase BB isoenzyme and study of lactate dehydrogenase pattern in metastatic adenocarcinoma of the prostate. Clin Biochem 13: 30–33

    PubMed  CAS  Google Scholar 

  • Schacht MJ, Garnett JE, Grayhack JT (1984) Biochemical markers in prostatic cancer. Urol Clin North Am 11: 253–257

    PubMed  CAS  Google Scholar 

  • Scher H (1983) Memorial Hospital CIC Protocol 82–54. Ethane hydroxy 1, 1-diphosphonate in the treatment of bone metastases from prostatic cancer.

    Google Scholar 

  • Scher H (1985) Memorial Hospital Protocol 85-25. Phase I-II trial of difluoromethylornithine (DFMO) and mitoguazone (MGBG) in hormone resistant bidimensionally measurable prostatic cancer.

    Google Scholar 

  • Scher H, Sternberg CN (1985) Chemotherapy of urologic malignancies. Semin Urol 3: 329–381

    Google Scholar 

  • Scher H, Yagoda A, Watson R et al. (1984) Phase II evaluation of adriamycin in bidimensionally measurable prostatic adenocarcinoma. J Urol 131: 1099–1102

    PubMed  CAS  Google Scholar 

  • Scher H, Tauer K, Alcock N et al. (1985a) Preliminary evaluation of gallium nitrate (GaN) on bone turnover and antitumor activity in patients ( Pts) with hormone resistant prostatic cancer metastatic to bone. Proc Am Soc Clin Oncol 4: 104

    Google Scholar 

  • Scher H, Yagoda A, Ahmed T et al. (1985b) Phase II trial of mitoguazone in bidimensionally measurable hormone resistant adenocarcinoma of the prostate. J Clin Oncol 3: 224–227

    PubMed  CAS  Google Scholar 

  • Scher H, Geller N, Muggia F, Rozencweig M (1986) Clinical evaluation of anticancer treatment: Phase II clinical trials. In: Muggia F, Rozencweig M (eds) Clinical evaluation of anticancer therapy. Martinus Nijhoff, Boston, pp 175–197

    Google Scholar 

  • Schipper H, Clinch J, McMurray A et al. (1984) Measuring the quality of life of cancer patients: the functional living index—cancer: development: and validation. J Clin Oncol 2: 472–483

    PubMed  CAS  Google Scholar 

  • Schmidt JD, Johnson DE, Scott WW et al. (1976) Chemotherapy of advanced prostatic cancer. Evaluation of response parameters. Urology 7: 602–610

    PubMed  CAS  Google Scholar 

  • Schmidt JD, Scott WW, Gibbons RP et al. (1979) Comparison of procarbazine, imidazole- carbamide and cyclophosphamide in relapsing patients with advanced carcinoma of the prostate. J Urol 121: 185–189

    PubMed  CAS  Google Scholar 

  • Schroeder FH and the European Organization on Research on Treatment of Cancer Urological Group (1984) Treatment response critieria for prostatic cancer. Prostate 5: 181–191

    Google Scholar 

  • Scott WW, Gibbons RP, Johnson DE et al. (1976) The continued evaluation of the effects of chemotherapy in patients with advanced carcinoma of the prostate. J Urol 116: 211–213

    PubMed  CAS  Google Scholar 

  • Seifter E, Bunn P, Cohen M et al. (1986) Combination chemotherapy followed by hormonal therapy for previously untreated metastatic carcinoma of the prostate. Proc Am Assoc Cancer Res 27: 183

    Google Scholar 

  • Selby P, Chapman JA, Etazadi-Amoli J et al. (1984) The development of a method for assessing quality of life in cancer. Br J Cancer 50: 13–22

    PubMed  CAS  Google Scholar 

  • Seppanen P, Alhonen-Hongisto L, Janne J (1981) Polyamine deprivation-induced enhanced uptake of methylglyoxal bis (guanylhydrazone) by tumor cells. Biochim Biophys Acta 674:169 Silverberg E (1985) Cancer statistics, CA 35: 19–35

    Google Scholar 

  • Simon R (1985) Design and conduct of clinical trials. In: DeVita VT, Hellman S, Rosenberg SA (eds) Principles and practice of oncology. J.P. Lippincott, Philadelphia, pp 329–350

    Google Scholar 

  • Simon R, Wittes R, Ellenberg S (1985) Randomized phase II clinical trials. Cancer Treat Rep 69: 1375–1381

    PubMed  CAS  Google Scholar 

  • Slack MH, Mittleman A, Brady MF, Murphy GP (1980) The importance of the stable category for chemotherapy treated patients with advanced and relapsing prostate cancer. Cancer 46: 2393–2402

    PubMed  CAS  Google Scholar 

  • Slack N, Brady M, Murphy G et al. (1985) Stable versus partial response in advanced prostate cancer. Prostate 5: 401–415

    Google Scholar 

  • Slack N, Lane W, Prior R, Murphy GP (1986) Prostatic cancer: treated at a categorical center, 1980–1983. Urology 27: 205–213

    PubMed  CAS  Google Scholar 

  • Tannock IF (1985) Is there evidence that chemotherapy is of benefit to patients with carcinoma of the prostate? J Clin Oncol 3: 1013–1020

    PubMed  CAS  Google Scholar 

  • Tannock I, Murphy K (1983) Reflections in medical oncology: an appeal for better clinical trials and improved reporting of their results. J Clin Oncol 1: 66

    PubMed  CAS  Google Scholar 

  • Termine JD, Kleinman HK, Whitson SW et al. (1981) Osteonectin, a bone-specific protein linking mineral to collagen. Cell 26: 99–104

    PubMed  CAS  Google Scholar 

  • Tonkin K, Tritchler D, Tannock I (1985) Criteria of tumor response used in clinical trials of chemotherapy. J Clin Oncol 3: 870–875

    PubMed  CAS  Google Scholar 

  • Torti F, Lum B (1985) Chemotherapy in prostate cancer. In: Garnick MB (ed) Genitourinary cancer. Churchill Livingstone, New York, pp 125–161

    Google Scholar 

  • Torti F, Aston D, Lum BL et al. (1983) Weekly doxorubicin in endocrine refractory carcinoma of the prostate. J Clin Oncol 1: 377–384

    Google Scholar 

  • Torti FM, Martin BC, Higgins MC et al. (1984) Skeletal metastases of prostatic carcinoma can subserve the function of measurable sites in prostatic cancer trials. Proc Am Soc Clin Oncol 4: 103

    Google Scholar 

  • Torti F, Shortliffe L, Carter S (1985) A randomized study of doxorubicin versus doxorubicin plus cisplatin in endocrine-unresponsive metastatic prostatic carcinoma. Cancer 56: 2580–2586

    PubMed  CAS  Google Scholar 

  • Torti FM, Flam M, Lum BL (1985) Weekly adriamycin and methotrexate in endocrine unresponsive carcinoma of the prostate. Proc Am Soc Clin Oncol 4: 103

    Google Scholar 

  • Trachtenberg J (1984) Ketoconazole therapy in advanced prostatic cancer. J Urol 132: 61–63

    PubMed  CAS  Google Scholar 

  • Trachtenberg J, Walsh PC (1982) Correlation of prostatic nuclear androgen receptor content with duration of response and survival following hormonal therapy in advanced prostatic cancer. J Urol 127: 466–471

    PubMed  CAS  Google Scholar 

  • University of Maryland Cancer Center Protocol #85-25 (1985) A phase II study of trimetrexate in endocrine resistant prostatic prostatic carcinoma.

    Google Scholar 

  • Warr D, McKinney S, Tannock I (1984) Influence of measurement error on assessment of response to anticancer chemotherapy: proposal for new criteria for tumor response. J Clin Oncol 2: 1040–1046

    PubMed  CAS  Google Scholar 

  • Whitmore WF (1973) The natural history of prostatic cancer. Cancer 32: 1104–1112

    PubMed  Google Scholar 

  • Wittes RE, Marsoni S, Simon R, Leyland-Jones BR (1985) The phase II trial. Cancer Treat Rep 69: 1235–1239

    PubMed  CAS  Google Scholar 

  • Yagoda A (1983) Response in prostatic cancer: an enigma. Semin Urol 1: 311–323

    PubMed  CAS  Google Scholar 

  • Yagoda A, Watson RC, Natale RB et al. (1979) A critical analysis of response criteria in patients with prostatic cancer treated with cis-diamminedichloride platinum II. Cancer 44: 1553–1562

    PubMed  CAS  Google Scholar 

  • Zelen M (1975) Importance of prognostic factors in planning therapeutic trials. In: Staquet M (ed) Cancer therapy: prognostic factors and criteria of response. Raven Press, New York, pp 1–15

    Google Scholar 

  • Zweig M, Ihde D (1985) Assessment of serum and enzymatic prostatic acid phosphatase and radioimmune creatine kinase BB for monitoring response to therapy in metastatic prostatic carcinoma. Cancer Research 45: 3945–3952

    PubMed  CAS  Google Scholar 

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© 1987 Springer-Verlag Berlin Heidelberg

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Scher, H.I., Yagoda, A. (1987). Clinical Trials in Prostatic Cancer: Methodology and Controversies. In: Bruce, A.W., Trachtenberg, J. (eds) Adenocarcinoma of the Prostate. Clinical Practice in Urology. Springer, London. https://doi.org/10.1007/978-1-4471-1398-0_13

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