PROSTATE CANCER REGISTRY
The Prostate Cancer Registry: Do Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Differ According to Metastatic Status at Diagnosis?
Simon Chowdhury,1 Alison J. Birtle,2 Anders Bjartell,3 Luis Costa,4,5 Susan Feyerabend,6 Luca Galli,7 Ewa Kalinka-Warzocha,8 Gero Kramer,9 Nicolaas Lumen,10 Pablo Maroto,11 Vsevolod B. Matveev,12 Thomas Paiss,13 Dominique Spaeth,14 Laurent Antoni,15 Edwin Klumper,16 Robert Wapenaar,17 and Emma Lee15 Guy’s Hospital, London, UK ([email protected]
); 2Rosemere Cancer Centre, Royal Preston Hospital, Preston, UK; 3Skåne University Hospital Malmö, Malmö, Sweden; 4Hospital de Santa Maria, Lisbon, Portugal; 5Instituto de Medicina Molecular, University of Lisbon, Lisbon, Portugal; 6Studienpraxis Urologie, Nürtingen, Germany; Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa, Italy; 8Wojewódzki Szpital Specjalistyczny im Kopernika, Łodz, Poland; 9Department of Urology, Medical University of Vienna, Vienna, Austria; 10Ghent University Hospital, Ghent, Belgium; 11Hospital de Sant Pau, Barcelona, Spain; 12N. N. Blokhin Cancer Research Center, Moscow, Russia; 13 Urologieteam Ulm, Ulm, Germany; 14Centre d’Oncologie de Gentilly, Nancy, France; 15EMEA Medical Affairs, Janssen Pharmaceutica, Beerse, Belgium; 16SMS-oncology BV, Amsterdam, the Netherlands; 17Janssen-Cilag BV, Tilburg, the Netherlands 1
OBJECTIVES ▶▶ Document the characteristics and management of patients with mCRPC in
routine clinical practice, independent of treatment used.
▶▶ Assess whether the subset of mCRPC patients who had metastatic disease at
initial diagnosis differ from those who did not in terms of clinical and disease characteristics in a real-life context.
METHODS Study Design ▶▶ Prospective, non-interventional, multicenter registry of > 3000 men with
mCRPC (ClinicalTrials.gov identifier: NCT02236637).
▶▶ Enrollment was initiated in 2013 and completed in early 2016. Study duration
will be 5.5 years with a maximum patient follow-up of 3 years.
▶▶ 199 centers in 16 countries across Europe are participating: Austria, Belgium,
France, Germany, Israel, Italy, Luxembourg, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the UK. Data from all countries except Israel and Turkey were available for this analysis. ▶▶ A range of clinical settings are represented, including oncology and urology specialist clinics, small and large practices, in both public and private healthcare systems.
Eligibility Criteria ▶▶ Male aged ≥ 18 years. ▶▶ Confirmed diagnosis of adenocarcinoma of the prostate with documented
metastatic disease, who may enroll at any time after diagnosis. ▶▶ Documented castration resistance defined as disease progression despite testosterone levels < 50 ng/dL and/or androgen deprivation therapy (ADT) and/or orchiectomy. Disease progression is defined by a rise in prostatespecific antigen (PSA) and/or worsening of existing disease/symptoms and/or appearance of new metastases.
–– Demographics –– Disease history, including dates of diagnosis, metastasis and castration resistance, tumor-node-metastasis (TNM) stage, and Gleason score at initial diagnosis –– Prior prostate cancer treatment, including systemic therapy, radiotherapy, and surgery –– Clinical characteristics, including comorbidities, concomitant medications, and Eastern Cooperative Oncology Group Performance Status (ECOG PS) –– Quality of life –– Medical resource utilization. ▶▶ Clinical data collected prospectively at least every 3 months: –– Systemic and local mCRPC treatment –– Rationale for treatment choice and reasons for discontinuation –– Duration and sequencing of treatment –– Clinical assessments/outcomes, biological parameters, and radiological responses –– Survival –– Quality of life –– Medical resource utilization. ▶▶ Data collected include only the data available per patient record; some patient records are not fully complete. ▶▶ All clinical data are subject to a validation process to ensure quality control.
prostatectomy or prostate radiotherapy) than M1 patients (Table 1). –– Among M0 patients, a higher proportion had prostate radiotherapy only compared with radical prostatectomy only, both surgery and radiotherapy to the prostate, or no local therapy (Figure 2).
Table 1. Patient Characteristics Before Study Entry M-status at initial diagnosis
withdrawal, loss to follow-up or death) with available data regarding metastatic (M)-status at time of initial diagnosis. ▶▶ Data are descriptive.
Prior to study entry Years from diagnosis to CRPC, median (range) Years from first M diagnosis to study entry, median (range) Radical prostatectomy, n (%) Prostate radiotherapy, n (%)
5.4 (0-20) 1.3 (0-15) 204 (38.8) 300 (57.0)
1.5 (0-16) 2.0 (0-13) 31 (5.6) 49 (8.9)
Figure 1. Time From Initial Diagnosis to Castration Resistance in M1 Patients 30
Patient Characteristics Before Start of Study
20 15 10 0
M0 n = 526
M1 n = 549
Age, years, mean (SD) ≥ 75 years, n (%)
73.6 (7.2) 241 (45.8)
70.6 (8.6) 187 (34.1)
ECOG PS, n (%)a 0-1 2 ≥3
436 (87.2) 51 (10.2) 13 (2.6)
426 (83.4) 71 (13.9) 14 (2.7)
n = 507 45.9 (0-5910) n = 234 273.0 (3-3232) n = 469 12.5 (7-17) n = 393 97.8 (2-2825) n = 376 0.30 (0.0-58.0)
n = 530 61.7 (0-10710) n = 190 273.0 (5-2890) n = 480 12.5 (7-16) n = 407 126.0 (1-3110) n = 406 0.31 (0.0-51.0)
M-status at initial diagnosis
12-18 18-24 Months
≥ 36 135
Biological parameters, median (range) Prostate-specific antigen, ng/mL Lactic acid dehydrogenase, U/L
Serum testosterone, ng/dL SD, standard deviation. a Some patients not evaluable.
Figure 3. Number of Bone Lesions at Study Entry (mCRPC) 60
Radical prostatectomy and prostate radiotherapy
No local therapy to prostate
0 Prostate radiotherapy only
Radical prostatectomy only
M0 at initial diagnosis M1 at initial diagnosis
10 0 n=
Weak-acting Strong-acting opioids opioids 52
M0, n = 526; M1, n = 549.
First Treatments for mCRPC on Study
Present, number unknown Number of bone lesions
treatments for mCRPC. The first documented treatment received on study was: –– M0 group, n (%): abiraterone 182 (39.7); enzalutamide 84 (18.3); docetaxel 146 (31.9); cabazitaxel 46 (10.0). –– M1 group, n (%): abiraterone 182 (40.1); enzalutamide 53 (11.7); docetaxel 173 (38.1); cabazitaxel 45 (9.9).
CONCLUSIONS ▶ In this real-life cohort of 1323 mCRPC patients, approximately
half presented with metastatic disease at initial diagnosis of prostate cancer. ▶ A higher percentage of patients with M1-status at diagnosis presented with aggressive and extended disease at mCRPC stage. ▶ M-status at initial diagnosis may be a clinical indicator of future treatment and prognosis in mCRPC, and follow-up of these patients over the course of the study will clarify how these differences and subsequent treatment may affect clinical outcomes.
1. Chowdhury S, et al. Poster presented at the 18th ECCO - 40th ESMO European Cancer Congress, 25-29 September 2015, Vienna, Austria. P039. 2. Chowdhury S, et al. Poster presented at the ISPOR 18th Annual European Congress 7-11 November 2015, Milan, Italy. PCN296.
M0 at initial diagnosis M1 at initial diagnosis
Figure 4. Analgesic Use at Study Entry
▶▶ A total of 458 (87.1%) M0 and 453 (82.5%) M1 patients initiated 1 or more new
Figure 2. History of Local Therapy to the Prostate in M0 Patients
Table 2. Patient and Disease Characteristics at Study Entry (mCRPC)
Alkaline phosphatase, U/L
40 35 30 25 20 15 10 5 0
younger, with a lower proportion aged ≥ 75 years at study entry (Table 2). ▶▶ M1 patients had slightly worse ECOG PS than M0 patients, with higher proportions with scores of 2 or ≥ 3 (Table 2). ▶▶ PSA and alkaline phosphatase levels were higher in the M1 than the M0 group (Table 2). ▶▶ At study entry, a higher proportion of patients in the M1 group had ≥ 5 bone metastases (lesions) compared with the M0 group (51.4% vs 41.4%; Figure 3); analgesic use was also higher among M1 patients (Figure 4).
▶▶ A higher proportion of patients with M1-status at initial diagnosis had a Gleason
score of 8-10 at initial diagnosis, and M1 patients also had a shorter time from diagnosis to castration resistance but longer time from first metastatic diagnosis to study entry, compared with M0 patients (Table 1). –– Time from diagnosis to castration resistance for the M1 patient group is shown in Figure 1; in 50% of patients, this was less than 18 months.
▶▶ A total of 1323 consecutive patients, enrolled between June 2013 and October
2014, were analyzed: 549 had distant metastases at initial diagnosis (M1, 41.5%), 526 did not (M0, 39.8%), and 248 were not evaluable (Mx, 18.7%). ▶▶ Data for patients with M1- and M0-status are described.
M1 n = 549
At initial diagnosis Gleason score 8-10, n (%)
Data Analysis ▶▶ This analysis was in patients with ≥ 12 months of follow-up (or less in case of
M0 n = 526
Patient Characteristics at Study Entry (mCRPC) ▶▶ Compared with M0 patients at initial diagnosis, initial M1 patients were slightly
Data Collection ▶▶ Baseline data collected at study entry included:
▶▶ As expected, M0 patients had received more prior local therapy (radical
outcomes in patients, based on the history and progression of the disease and how it is managed. ▶▶ In particular, patients who have metastatic disease at diagnosis may differ from patients diagnosed with localized disease who subsequently develop metastases; these differences could have important implications for treatment strategies after castration resistance develops. ▶▶ Observational data can provide important perspectives on the optimal management of such patients; however, real-world data in mCRPC are limited. ▶▶ The Prostate Cancer Registry, the first international, prospective, observational study of patients with mCRPC, was initiated to examine the characteristics and management of patients with mCRPC in routine clinical practice; previous descriptive analyses of 505 patients indicated enrollment of a real-world patient population.1,2
sparing therapies) or initiating new treatment for mCRPC within the 30 days preceding or following enrollment. ▶▶ Signed informed consent/participation agreement, as applicable.
▶▶ The stage at which prostate cancer is diagnosed may influence clinical
▶▶ Not currently receiving active treatment for mCRPC (except ADT and/or bone-
Data are % patients with a record of bone lesion assessment at study entry: M0, n = 362; M1, n = 413.
The authors would like to acknowledge the dedicated efforts of the investigational sites that contributed to the database and to thank patients who allowed collection of their data. This study and the analyses presented here were funded by Janssen EMEA; writing assistance was provided by PAREXEL and was funded by Janssen EMEA. An electronic version of the poster can be viewed by scanning the Quick Response (QR) code. The QR code is intended to provide scientific information for personal use only. The poster should not be altered and may not be reproduced without permission from ASCO® and the authors.
Poster presented at the 2016 ASCO Annual Meeting, 3-7 June 2016, Chicago, USA ♦ Supported by funding from Janssen EMEA
GS0645 ASCO 2016 PCR M-stage Chowdhury S03.indd 1