Lead Investigator: Thomas Büttner, University Hospital Bonn
Title of Proposal Research: Evaluation of Bellmunt Risk Score as a prognostic score in metastatic-castration resistant prostate cancer
Vivli Data Request: 9924
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Metastatic castration-resistant prostate cancer (mCRPC) is an aggressive, incurable and often lethal condition. It is characterized by two factors: A prostate cancer (a type of cancer that forms in the prostate gland) which has spread beyond the prostate, forming so-called metastases. Moreover, the cancer no longer responds to anti-hormonal treatment, a therapy that aims to inhibit or block the production/effects of certain hormones in the body, and therefore requires further therapy. In a western population, about 6 in 1000 men suffer from mCRPC and approximately 2 in 1000 men are newly diagnosed per year.
Patients often want information about how long they will survive with this disease given their individual life plans or family and relationship bounds. Therefore, we aim to provide patients and their doctors an easy tool to predict the survival times.
The so-called Bellmunt Risk Score looks at the three factors: overall health status, blood count (hemoglobin) levels, and whether the cancer has spread to the liver. A score of 0 – 3 can quickly be built only from these factors.
In a small study involving 125 men with mCRPC, we already found that the Bellmunt Risk Score could be useful in predicting survival. While men with a score of 0 lived for approximately 4 years, men with scores larger than 2 only lived for about one year. With overall health status collected more accurate, a modified Bellmunt Risk score even improved these predictions. However, we need proof for these findings in studies with larger groups of patients.
We aim at extracting Bellmunt Risk Score and survival times from the data of large controlled studies. We want to discover, if we can confirm our previous findings. This is possible by comparing the survival times of men with each score of 0, 1, 2 and 3 using the established statistical tools “Cox regression analysis” and “Log-Rank analysis”. If we find significant differences between these groups, this score could become a valuable tool for doctors and patients, helping them to be informed and make better decisions about treatment.
Requested Studies:
A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Data Contributor: Johnson & Johnson
Study ID: NCT02257736
Sponsor ID: CR105505
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy
Data Contributor: Johnson & Johnson
Study ID: NCT01695135
Sponsor ID: CR100010
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy
Data Contributor: Takeda
Study ID: NCT01193257
Sponsor ID: C21005
Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy
Data Contributor: Sanofi
Study ID: NCT01308567
Sponsor ID: EFC11784
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Data Contributor: Johnson & Johnson
Study ID: NCT00887198
Sponsor ID: CR016927