Combination therapy with radium-223 and abiraterone acetate in mCRPC


We understand from the manufacturers that the so-called ERA-223 trial — a randomized, double-blind, multi-center, Phase III trial of radium-223 acetate (Xofigo) + abiraterone acetate (Zytiga) + prednisone compared to a placebo + abiraterone acetate + prednisone — is now fully enrolled.

This trial, in men who had metastatic, castration-resistant prostate cancer (mCRPC), was designed to see whether the addition of radium-223 to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bones, such as painful fractures or bone pain which needs to be treated with radiation therapy. Patients have been enrolled at > 200 centers around the world.

About 800 patients were originally scheduled to be enrolled in this trial, with about 400 in each of the two study arms. The patients enrolled in this trial had to have

 

  • Two or more bone metastases on bone scan within 4 weeks prior to randomization, but no lung, liver, other visceral and/or brain metastasis
  • Asymptomatic or mildly symptomatic prostate cancer
  • Medical or surgical castration with a testosterone level less than 50 ng/dl (1.7 nmol/l)
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

In addition, any patients who had been receiving combined androgen blockade with an anti-androgen in addition to an LHRH agonist (or an orchiectomy) must have shown PSA progression after discontinuing the anti-androgen prior to enrollment in the trial.

According to the information on the ClinicalTrials.gov web site, we can expect initial results from this trial in late 2017 or early 2018. Those initial results are likely to be limited to any effects on time to fractures or bone pain (i.e., symptomatic skeletal event-free survival) and time to the use of opioid therapy to manage bone pain. It may take another 2 or 3 years (e.g., late 2020) before data are available on overall and prostate cancer-specific survival rates.

 

One Response

  1. Mike,

    I did this same combination in 2014. I did have some benefits, with August 2015 scans showing improvement, but then did progress fairly rapidly and scans in January 2015 showed interval progression in bones and lymph nodes plus the appearance of liver metastases.

    I hope the trial has better results.

    Bill Manning

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