Canary Prostate Active Surveillance Study: Design of a Multi-institutional Active Surveillance Cohort and Biorepository

Active surveillance is a management plan for localized prostate cancer that offers selective delayed intervention on indication of disease progression, allowing patients to delay or avoid treatment and associated side-effects. Outcomes from centers that promote active surveillance are favorable, with high rates of disease-specific survival. However, there remains a need for prognostic variables or biomarkers that distinguish with high specificity the aggressive cancers that progress on surveillance from the indolent cancers. The Canary Prostate Active Surveillance Study is a multicenter study and a biorepository that will discover and confirm biomarkers of aggressive disease as defined by histologic, prostate-specific antigen, or clinical criteria. Active surveillance is a management plan for localized prostate cancer that offers selective delayed intervention on indication of disease progression, allowing patients to delay or avoid treatment and associated side-effects. Outcomes from centers that promote active surveillance are favorable, with high rates of disease-specific survival. However, there remains a need for prognostic variables or biomarkers that distinguish with high specificity the aggressive cancers that progress on surveillance from the indolent cancers. The Canary Prostate Active Surveillance Study is a multicenter study and a biorepository that will discover and confirm biomarkers of aggressive disease as defined by histologic, prostate-specific antigen, or clinical criteria. Prostate cancer is a heterogeneous disease. Although various clinical and pathologic parameters are associated with prostate cancer progression and recurrence, the natural history of localized prostate cancer is not completely understood. Prostate cancer is the most commonly diagnosed cancer among men in the United States, and the second leading cause of cancer mortality,1Jemal A. Siegel R. Ward E. et al.Cancer statistics, 2008.CA Cancer J Clin. 2008; 58: 71-96Crossref PubMed Scopus (10240) Google Scholar although there is clear evidence that a significant percentage of prostate cancers existing in the population will never become clinically evident or cause mortality. Autopsy studies have demonstrated that approximately 1 in 3 men aged > 50 years has histologic evidence of prostate cancer, but up to 80% of the tumors are small in size (< 0.5 cm) and low in grade, suggesting they are clinically insignificant.2Yatani R. Chigusa I. Akazaki K. et al.Geographic pathology of latent prostatic carcinoma.Int J Cancer. 1982; 29: 611-616Crossref PubMed Scopus (284) Google Scholar Furthermore, comparisons of autopsy-detected prostate cancer rates before and after prostate-specific antigen (PSA) testing was introduced, showing a decrease in prevalence after PSA testing became widely used.3Konety B.R. Bird V.Y. Deorah S. et al.Comparison of the incidence of latent prostate cancer detected at autopsy before and after the prostate specific antigen era.J Urol. 2005; 174 (discussion:1788): 1785-1788Abstract Full Text Full Text PDF PubMed Scopus (77) Google Scholar These data are concordant with studies comparing prostate cancer mortality in the absence and presence of PSA screening, which suggest widespread use of PSA screening may be at least in part responsible for the decrease in mortality because of prostate cancer from 1990 to 2004.4Etzioni R. Tsodikov A. Mariotto A. et al.Quantifying the role of PSA screening in the US prostate cancer mortality decline.Cancer Causes Control. 2008; 19: 175-181Crossref PubMed Scopus (309) Google Scholar, 5Collin S.M. Martin R.M. Metcalfe C. et al.Prostate-cancer mortality in the USA and UK in 1975–2004: an ecological study.Lancet Oncol. 2008; 9: 445-452Abstract Full Text Full Text PDF PubMed Scopus (211) Google Scholar, 6Schroder F.H. Hugosson J. Roobol M.J. et al.Screening and prostate-cancer mortality in a randomized European study.N Engl J Med. 2009; 360: 1320-1328Crossref PubMed Scopus (3280) Google Scholar However, not only is there is a growing appreciation that widespread PSA screening also results in overdiagnosis of a substantial portion of prostate cancers,6Schroder F.H. Hugosson J. Roobol M.J. et al.Screening and prostate-cancer mortality in a randomized European study.N Engl J Med. 2009; 360: 1320-1328Crossref PubMed Scopus (3280) Google Scholar, 7Etzioni R. Penson D.F. Legler J.M. et al.Overdiagnosis due to prostate-specific antigen screening: lessons from U.S. prostate cancer incidence trends.J Natl Cancer Inst. 2002; 94: 981-990Crossref PubMed Scopus (757) Google Scholar, 8Yao S.L. Lu-Yao G. Understanding and appreciating overdiagnosis in the PSA era.J Natl Cancer Inst. 2002; 94: 958-960Crossref PubMed Scopus (43) Google Scholar but also, there is some recent evidence that death rates, albeit very low, do not differ significantly in nonscreened vs screened populations.9Andriole G.L. Grubb III, R.L. Buys S.S. et al.Mortality results from a randomized prostate-cancer screening trial.N Engl J Med. 2009; 360: 1310-1319Crossref PubMed Scopus (2392) Google Scholar These controversies underlie the critical need for better predictive tools or biomarkers that will aid clinicians in the discrimination of tumors that warrant treatment and those that fall into the category of overdiagnosis. Optimal management of newly diagnosed, clinically localized prostate cancers remains controversial. Therapy options include various forms of radiation or surgery with curative intent, surveillance with or without delayed intervention, systemic therapy, most commonly androgen deprivation, or newly emerging focal ablative therapies. Surgery and radiation, while potentially highly curative in selected patients, are associated with various well established and significant side effects such as incontinence, erectile dysfunction, bowel dysfunction, and lower urinary tract symptoms. Active surveillance is a disease management method that offers selective delayed radical intervention on indication of disease progression as defined by the rate of rise of PSA and/or results of repeat prostate biopsy. This approach began to be used as a management plan in selected patients with clinically localized prostate cancer in the early to mid 1990s.10Choo R. Klotz L. Danjoux C. et al.Feasibility Study Watchful waiting for localized low to intermediate grade prostate carcinoma with selective delayed intervention based on prostate specific antigen, histological and/or clinical progression.J Urol. 2002; 167: 1664-1669Abstract Full Text Full Text PDF PubMed Google Scholar It built upon watchful waiting, which has long been recognized as an approach to manage some cancers, and has been demonstrated to have excellent long-term results in selected patients.11Albertsen P.C. Hanley J.A. Fine J. 20-Year outcomes following conservative management of clinically localized prostate cancer.J Am Med Assoc. 2005; 293: 2095-2101Crossref PubMed Scopus (1020) Google Scholar Active surveillance, which is sometimes called “expectant management with curative intent” differs from the more conventional method of “watchful waiting,” a policy of comparatively lax observation using palliative treatment for symptomatic progression.12Parker C. Active surveillance: towards a new paradigm in the management of early prostate cancer.Lancet Oncol. 2004; 5: 101-106Abstract Full Text Full Text PDF PubMed Scopus (163) Google Scholar The aim of active surveillance is to identify patients for curative treatment at the first sign of subclinical progression, long before any symptoms or overt signs of tumor progression are evident. The challenge of managing localized prostate cancer is in distinguishing the patients with clinically relevant cancers, who may benefit from immediate radical intervention, from the remainder who do not need intervention. Several variables, including PSA level and kinetics, biopsy primary and secondary Gleason score, extent of disease on biopsy, and clinical T-stage, are associated with risk of disease progression and metastasis.13Dong F. Kattan M.W. Steyerberg E.W. et al.Validation of pretreatment nomograms for predicting indolent prostate cancer: efficacy in contemporary urological practice.J Urol. 2008; 180 (discussion:154): 150-154Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar, 14Kattan M.W. Cuzick J. Fisher G. et al.Nomogram incorporating PSA level to predict cancer-specific survival for men with clinically localized prostate cancer managed without curative intent.Cancer. 2008; 112: 69-74Crossref PubMed Scopus (60) Google Scholar Although there is debate regarding the appropriate PSA threshold for screening, most investigators agree that PSA > 10 ng/mL usually predicts more aggressive tumors.15Thompson I.M. Pauler D.K. Goodman P.J. et al.Prevalence of prostate cancer among men with a prostate-specific antigen level < or = 4.0 ng per milliL.N Engl J Med. 2004; 350: 2239-2246Crossref PubMed Scopus (1961) Google Scholar Gleason score is also an independent prognostic variable that influences the outcome of prostate cancer patients,16Roehl K.A. Han M. Ramos C.G. et al.Cancer progression and survival rates following anatomical radical retropubic prostatectomy in 3,478 consecutive patients: long-term results.J Urol. 2004; 172: 910-914Abstract Full Text Full Text PDF PubMed Scopus (732) Google Scholar and Gleason sum of 6 or lower is often used to define low-risk prostate cancer.17Dall'Era M.A. Cooperberg M.R. Chan J.M. et al.Active surveillance for early-stage prostate cancer: review of the current literature.Cancer. 2008; 112: 1650-1659Crossref PubMed Scopus (252) Google Scholar However, analyses of prognostic features of men who have died of prostate cancer indicate that one-third to one-half of men who die from prostate cancer were diagnosed with Gleason 6 grade or lower.11Albertsen P.C. Hanley J.A. Fine J. 20-Year outcomes following conservative management of clinically localized prostate cancer.J Am Med Assoc. 2005; 293: 2095-2101Crossref PubMed Scopus (1020) Google Scholar, 18Thompson I. Thrasher J.B. Aus G. et al.Guideline for the management of clinically localized prostate cancer: 2007 update.J Urol. 2007; 177: 2106-2131Abstract Full Text Full Text PDF PubMed Scopus (867) Google Scholar None of the prognostic variables, alone or together,19Kattan M.W. Eastham J.A. Wheeler T.M. et al.Counseling men with prostate cancer: a nomogram for predicting the presence of small, moderately differentiated, confined tumors.J Urol. 2003; 170: 1792-1797Abstract Full Text Full Text PDF PubMed Scopus (306) Google Scholar, 20Steyerberg E.W. Roobol M.J. Kattan M.W. et al.Prediction of indolent prostate cancer: validation and updating of a prognostic nomogram.J Urol. 2007; 177: 107-112Abstract Full Text Full Text PDF PubMed Scopus (253) Google Scholar provide sufficient specificity for identifying aggressive disease, and currently over 90% of patients with newly diagnosed prostate cancer are treated.21Cooperberg M.R. Broering J.M. Kantoff P.W. et al.Contemporary trends in low risk prostate cancer: risk assessment and treatment.J Urol. 2007; 178: S14-S19Abstract Full Text Full Text PDF PubMed Scopus (385) Google Scholar, 22Cooperberg M.R. Lubeck D.P. Meng M.V. et al.The changing face of low-risk prostate cancer: trends in clinical presentation and primary management.J Clin Oncol. 2004; 22: 2141-2149Crossref PubMed Scopus (498) Google Scholar These data demonstrate the need for biomarkers for prostate cancer that complement conventional risk assessment. There is a clear need for markers that can predict prostate cancer behavior and that can segregate, with a high degree of specificity, diseases that may be cured with treatment from those that are indolent and for which immediate treatment is unnecessary. Reported outcomes from many centers that promote active surveillance to manage prostate cancer are quite favorable. Presently, there is no consensus on the optimal active surveillance protocol, and the eligibility and treatment criteria, reviewed by van As and Parker23van As N.J. Parker C.C. Active surveillance with selective radical treatment for localized prostate cancer.Cancer J. 2007; 13: 289-294Crossref PubMed Scopus (49) Google Scholar and Dall'Era et al,17Dall'Era M.A. Cooperberg M.R. Chan J.M. et al.Active surveillance for early-stage prostate cancer: review of the current literature.Cancer. 2008; 112: 1650-1659Crossref PubMed Scopus (252) Google Scholar respectively, differ among the various centers. However, all criteria, given in Table 1, resemble those in the report on active surveillance from Toronto, the study with the longest follow-up.10Choo R. Klotz L. Danjoux C. et al.Feasibility Study Watchful waiting for localized low to intermediate grade prostate carcinoma with selective delayed intervention based on prostate specific antigen, histological and/or clinical progression.J Urol. 2002; 167: 1664-1669Abstract Full Text Full Text PDF PubMed Google Scholar, 25Klotz L. Active surveillance with selective delayed intervention for favorable risk prostate cancer.Urol Oncol. 2006; 24: 46-50Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar This study included 299 participants with T1/T2a disease, Gleason score less than or equal to 3 + 4, and PSA < 15 ng/mL. Patients were monitored with digital rectal examination (DRE) and PSA assays every 3 months for and every 6 months the PSA level was with were at 1 and every 3 Patients were to radical treatment at any and radical treatment was the PSA was < 3 years or the repeat an to Gleason + 3 or a of participants on surveillance and patients the participants who died of prostate cancer in the a PSA < were 6 and disease a of patients disease at and not have from immediate radical L. Active surveillance with selective delayed intervention for favorable risk prostate cancer.Urol Oncol. 2006; 24: 46-50Abstract Full Text Full Text PDF PubMed Scopus (110) Google active surveillance and/or of M.A. B.R. et al.Active surveillance for the management of prostate cancer in a contemporary 2008; 112: PubMed Scopus Google < 10 sum 6 and PSA > sum on in by biopsy R. Klotz L. Danjoux C. et al.Feasibility Study Watchful waiting for localized low to intermediate grade prostate carcinoma with selective delayed intervention based on prostate specific antigen, histological and/or clinical progression.J Urol. 2002; 167: 1664-1669Abstract Full Text Full Text PDF PubMed Google Scholar, 25Klotz L. Active surveillance with selective delayed intervention for favorable risk prostate cancer.Urol Oncol. 2006; 24: 46-50Abstract Full Text Full Text PDF PubMed Scopus (110) Google 10 ng/mL 15 ng/mL aged > sum 6 + aged > 3 sum on in A. C. et management of prostate cancer with curative an of the Urol. 2007; 178: Full Text Full Text PDF PubMed Scopus Google sum 6 and 1 sum on or any 1 and E. et of men with clinically localized prostate cancer who Urol. 2004; Full Text Full Text PDF PubMed Scopus Google sum based score > detected biopsy As N.J. Parker C.C. Active surveillance with selective radical treatment for localized prostate cancer.Cancer J. 2007; 13: 289-294Crossref PubMed Scopus (49) Google 15 sum + 10 1 > 10 > 1 score + 3 on repeat in a new from studies are as in Table one-third of men on active surveillance with high disease-specific survival in all of data from participants in the European Study of for Prostate Cancer who were managed by active surveillance and watchful waiting, and who to active surveillance to those used in the of active R. Klotz L. Danjoux C. et al.Feasibility Study Watchful waiting for localized low to intermediate grade prostate carcinoma with selective delayed intervention based on prostate specific antigen, histological and/or clinical progression.J Urol. 2002; 167: 1664-1669Abstract Full Text Full Text PDF PubMed Google Scholar are with results in Table S. Roobol M.J. et of men with prostate cancer for active surveillance who were managed Urol. 2009; Full Text Full Text PDF PubMed Scopus Google Scholar from men with a of months a prostate cancer-specific survival of which with the survival. These as a demonstrate that an active surveillance using selective delayed intervention for men with low-risk prostate cancer is and is associated with low rates of significant prostate cancer progression and However, given the often natural history of prostate cancer, the from remains there is data or validation of appropriate results from studies be with confirm and active surveillance as a management plan for clinically localized prostate cancer, for the results from randomized comparing active surveillance with active The Prostate Cancer that randomized men with localized disease radical prostatectomy and watchful waiting is the only randomized A. L. F. et prostatectomy watchful waiting in localized prostate cancer: the prostate cancer randomized Natl Cancer Inst. 2008; PubMed Scopus Google Scholar although is to that watchful waiting as to active a of and to radical prostatectomy was associated with a benefit in of disease-specific mortality and survival. mortality at years was for the surgery and for the watchful waiting = = However, the outcome data from were based on clinically detected disease and be to prostate of prostate cancers, for were detected by PSA and of tumors with in which is a tumor than in in active surveillance studies in the United and is to the disease-specific mortality of in watchful waiting of the to the disease-specific mortality of in the active surveillance There are currently 3 randomized that aim to active treatment with management of prostate The Prostate Cancer vs for which has been with also radical prostatectomy with watchful M.J. et al.The Prostate Cancer and results of a randomized comparing radical prostatectomy to watchful waiting for men with clinically localized prostate Clin 2009; Full Text Full Text PDF PubMed Scopus Google Scholar of patients with cancers detected were However, radical treatment for all to be better than radical treatment for will the of treatment for a based on progression on active surveillance be as but less with disease-specific mortality. The Prostate for Cancer and radical and active J. F. et testing for cancer and treatment 2003; PubMed Scopus Google Scholar The study to and active for a small of men with very PSA The Study of Active Surveillance Therapy in Patients with Prostate Cancer will disease-specific survival of patients with favorable risk prostate cancer who have been at the of to radical treatment or active This which for in is the only randomized with an active surveillance in which participants will be treatment based on histologic, or clinical criteria. or upon disease progression, will have a prostatectomy or M. et the optimal treatment for localized prostate cancer patients: a of studies at the Cancer of Oncol. 2008; PubMed Google Scholar of study provide active surveillance is or to active treatment for the management of clinically localized prostate Active surveillance the are to biomarkers that be used to treatment to men who to benefit from therapy, and avoid intervention in those for is unnecessary. of the and which have been as a in a of prostate S. et of and in prostate 2005; PubMed Scopus Google Scholar have been associated with risk disease features in small F. K. S. et associated with prostate cancer in a watchful waiting 2007; PubMed Scopus Google Scholar, A. R. in the and prostate J Cancer. 2008; PubMed Scopus Google Scholar However, the is not associated with A. M.A. J.M. et is not associated with outcome in patients by 2009; PubMed Scopus Google Scholar and studies in the prostate or of are to the prognostic of the the active surveillance studies currently are of only that and that may be used for study at in the United C. Active surveillance: towards a new paradigm in the management of early prostate cancer.Lancet Oncol. 2004; 5: 101-106Abstract Full Text Full Text PDF PubMed Scopus (163) Google Scholar, As N.J. Parker C.C. Active surveillance with selective radical treatment for localized prostate cancer.Cancer J. 2007; 13: 289-294Crossref PubMed Scopus (49) Google Scholar and the Canary Prostate Active Surveillance in the The Canary Prostate Active Surveillance Study is a active surveillance study that is currently participants at of of of and of at The study is by the Canary and the of the Cancer The primary is to discover and confirm biomarkers that predict aggressive disease as defined by histologic, and clinical criteria, or outcomes based on those are to the of patients on active surveillance who progress based on defined criteria, and to the clinical of disease The study is patients with early prostate cancer, of of who have active surveillance as a management plan for prostate The eligibility are given in Table These are and are to most men who active surveillance without to The of disease is to provide into the natural history of prostate cancer and as the for a of and progression treatment for prostate cancer and but not or radiation therapy, or or active surveillance as management plan for prostate 1 of at least 1 biopsy with 10 > 1 before of 1 years before cancer or cancer, or tumors with no evidence of disease for > PSA < 3 in Gleason and but not or in a new will be by and prostate to the in Table PSA are every 3 months from the of and are at study and every 6 months from the of Patients who are diagnosed 1 before study will repeat biopsy at the a biopsy with at least 10 is not at months from the at every Patients who are diagnosed at > 1 before the will repeat biopsy with the following at only 1 biopsy or the most recent biopsy was > years before the and every years from the most recent biopsy. 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Active surveillance studies such as provide the to study the natural history of localized prostate cancer and to with the validation of of of men in the United alone be the and associated with the treatment of prostate

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