The Prostate Cancer Registry: First results from an international, prospective, observational study of men with metastatic castration-resistant prostate cancer (mCRPC)


Author: Simon Chowdhury 

Background: The Prostate Cancer Registry is the first international, prospective, observational study documenting the characteristics and management of patients with mCRPC in routine clinical practice, independent of treatment prescribed. The registry aims to provide real-world insights into how different therapies are used in routine practice, including those that have recently become available.

Materials and Methods: The registry aims to enroll 3000 mCRPC patients and to follow them for a maximum of 3 years. As of April 2015, 2051 patients with mCRPC from >150 centers across 16 countries have enrolled in the Prostate Cancer Registry (NCT02236637). Patients are enrolled upon initiating a mCRPC treatment or in a period of surveillance, defined as not currently receiving an active treatment for castration resistance; androgen deprivation and bone-sparing treatments can continue. At enrolment, information on disease history is collected, followed by prospective data capture of patient characteristics, clinical status, disease management, quality of life, medical resource utilization and outcomes, including survival.

Results: We report data of 505 patients enrolled between June 2013 and January 2014 and followed for up to 9 months. The mean age was 71.5 years with a mean time since diagnosis of 5.7 years. Historical data at diagnosis indicate that 60% of patients had a Gleason score ⩾8 and that 46% were metastatic. In addition, 22% of patients had undergone radical prostatectomy and 33% had received radiotherapy to the prostate. Metastatic lesions were observed in the bone (79%), lung (9%) and liver (6%). Most patients (63%) had ⩾1 comorbidity (55% cardiovascular disease; 13% diabetes) and 79% had received ⩾1 concomitant therapy (48% analgesics; 45% antihypertensives). Of 505 patients, 296 were chemotherapy-naïve at study entry and 209 had received prior chemotherapy.

At enrolment, 58% of patients initiated mCRPC treatment. By the 9-month follow-up period, 383 of 505 patients (76%) had started a new mCRPC treatment(s) with first treatments in the study being abiraterone (n = 171; 45%), enzalutamide (n = 46; 12%), docetaxel (n = 117; 31%), and cabazitaxel (n = 44; 12%).

Within the 9-month follow-up period, of those patients starting a new mCRPC treatment 287 of 383 patients (75%) received one line of therapy.

Conclusions: These first results provide detailed information on patient characteristics, disease status and treatment in mCRPC patients outside randomized clinical trials in a variety of clinical settings, across a number of countries. These data represent valuable insights into clinical practice. As these data mature, we expect to further enhance our understanding of treatment patterns in mCRPC, with the aim of improving outcomes for patients.