The Prostate Cancer Registry (NCT02236637) is the first prospective, international, observational study to describe routine management of mCRPC. The registry has enrolled over 3000 patients, with up to 3 years' follow-up. This analysis reports baseline characteristics, treatments and first clinical outcomes in 1374 patients.
Data collected prospectively from medical records of men with documented mCRPC initiating a new mCRPC treatment or in surveillance (no active treatment; ongoing androgen deprivation and/or bone-targeted therapy allowed). Data and analyses were descriptive.
Median follow-up at database close was 14.2 months (range: 0.2-28.6). Mean age at enrolment was 72.6 years; 55% of patients had a Gleason score ≥ 8 at diagnosis. 58.5% of patients had comorbidities at enrolment, most commonly cardiovascular disorders (51.7%; 41.3% hypertension) and diabetes (15.2%). 876 patients (63.8%) were chemotherapy-naïve at enrolment. During the 12-month observation period, 1191 patients (86.7%) initiated new mCRPC treatment. Descriptive, non-comparative data on previous treatment lines and time to next therapy by first documented treatment received on study are in the table.
|Chemotherapy-naïve treatment||Chemotherapy-naïve treatment||First chemotherapy treatment||Post-chemotherapy treatment||Post-chemotherapy treatment||Post-chemotherapy treatment||Post-chemotherapy treatment|
|First documented treatment received on study (treatments with n ≥ 50)||Abiraterone acetate + prednisone (n = 324)||Enzalutamide (n = 53)||Docetaxel (n = 326)||Abiraterone acetate + prednisone (n = 164)||Enzalutamide (n = 111)||Docetaxel (n = 58)`||Cabazitaxel (n = 119)|
|Number of previous mCRPC treatments, n (%)|
|0||313 (96.6)||42 (79.2)||295 (90.5)||0||0||0||0|
|1||11 (3.4)||11 (20.8)||29 (8.9)||121 (73.8)||61 (55.0)||35 (60.3)||43 (36.1)|
|2||0||0||2 (0.6)||37 (22.6)||29 (26.1)||14 (24.1)||59 (49.6)|
|≥3||0||0||0||6 (3.6)||21 (18.9)||9 (15.5)||17 (14.3)|
|Median time to next therapy, days (95% CI)*||601 (467, NE)||503 (251, NE)||278 (259, 307)||428 (359, 514)||366 (296, NE)||322 (239, 404)||264 (240, 321)|
*Kaplan–Meier estimates; patients with no next therapy were censored. Time to next therapy: time from start of 1st therapy to start of next therapy. NE, not estimable.
The results provide unique insights into treatment and outcomes in a large, real-world mCRPC patient population. These older patients have a high prevalence of comorbidities that are common in clinical practice but often not taken into account in the results of interventional clinical trials. Follow-up of these patients will allow assessment of treatment patterns and outcomes, and thereby contribute to optimising outcomes in subsets of mCRPC patients in clinical practice.
Clinical trial identification
Legal entity responsible for the study
S. Chowdhury: Consultant - Janssen Pharmaceuticals; Speakers' Bureau - Janssen Pharmaceuticals, Sanofi, Astellas Pharma Profession: Consultant medical oncologist. A.J. Birtle: Educational grants and advisory boards fees Janssen Sanofi Aventis Astellas, Roche. A. Bjartell: Consultant: EXINI Diagnostics, Speakers' Bureau: Astellas Pharma, Bayer Schering Pharma, Patents, Royalties, Other Intellectual Property: Glactone Pharma. L.A.;. Costa: Speakers' Bureau: Janssen. E. Kalinka-Warzocha: Honoraria, Consultant. Research Funding: Bristol-Myers Squibb, MSD, Roche, Novartis, Janssen, Angelini Pharmaceuticals. Travel, Accommodations, Expenses: MSD, Bristol-Myers Squibb, Roche.
G. Kramer: Honoraria – Janssen, Bayer, Astellas Pharma, Sanofi; Consultant – Janssen, Bayer, Astellas Pharma, GlaxoSmithKline, Sanofi, Ipsen, Takeda. Research Funding - Janssen, Bayer, Astellas Pharma
J.P. Maroto Rey: Consultant - Janssen Pharmaceuticals, Amgen, Bayer Schering Pharma, Novartis, Roche. Speakers' Bureau - Janssen Pharmaceuticals, Amgen, Bayer, Novartis, Roche.
N. Lumen: Honoraria – Lilly, Janssen, AstraZeneca; Consultant – Bayer; Research Funding – Janssen, Bayer, Astellas Pharma, Ipsen; Travel, Accommodations, Expenses – Bayer, Janssen, Ipsen, Astellas Pharma.
D. Spaeth: Honoraria – Roche, Sanofi, Amgen, Pfizer; Consultant – Roche, Sanofi, Amgen, Pfizer. Research Funding – Roche, Pierre Fabre; Other Relationship – Roche, Novartis, Pierre Fabre, Sanofi.
L. Antoni: Employment - Janssen Pharmaceutica.
E. Klumper: Consultant - Janssen Pharmaceuticals.
R. Wapenaar: Stock and Other Ownership Interests - Johnson & Johnson.
E. Lee: Stock and Other Ownership Interests – Janssen.
All other authors have declared no conflicts of interest.