Related Experiment Video
Updated: May 5, 2026
A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
Published on: March 6, 2018
A randomised phase 2 study combining LY2181308 sodium (survivin antisense oligonucleotide) with first-line
Paweł Wiechno1, Bradley G Somer2, Begoña Mellado3
1Uro-Oncology Department, Cancer Center, Warsaw, Poland.
Abstract:
Castration-resistant prostate cancer (CRPC) is partially characterised by overexpression of antiapoptotic proteins, such as survivin. In this phase 2 study, patients with metastatic CRPC (n=154) were randomly assigned (1:2 ratio) to receive standard first-line docetaxel/prednisone (control arm) or the combination of LY2181308 with docetaxel/prednisone (experimental arm). The primary objective was to estimate progression-free survival (PFS) for LY2181308 plus docetaxel. Secondary efficacy measures included overall survival (OS), several predefined prostate-specific antigen (PSA)-derived end points, and Brief Pain Inventory (BPI) and Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores. The median PFS of treated patients for the experimental arm (n=98) was 8.64 mo (90% confidence interval [CI], 7.39-10.45) versus 9.00 mo (90% CI, 7.00-10.09) in the control arm (n=51; p=0.755). The median OS for the experimental arm was 27.04 mo (90% CI, 19.94-33.41) compared with 29.04 mo (90% CI, 20.11-39.26; p=0.838). The PSA responses (≥ 50% PSA reduction), BPI, and FACT-P scores were similar in both arms. In the experimental arm, patients had a numerically higher incidence of grades 3-4 neutropenia, anaemia, thrombocytopenia, and sensory neuropathy. In conclusion, this study failed to detect a difference in efficacy between the two treatment groups.
Insights
This study investigated LY2181308 plus docetaxel for castration-resistant prostate cancer (CRPC). The combination therapy showed no significant improvement in progression-free survival or overall survival compared to standard treatment.
Area of Science:
- Oncology
- Clinical Trials
- Prostate Cancer Research
Background:
- Castration-resistant prostate cancer (CRPC) is often associated with increased antiapoptotic proteins like survivin.
- Standard first-line treatment for metastatic CRPC involves docetaxel and prednisone.
Purpose of the Study:
- To evaluate the efficacy of combining LY2181308 with docetaxel/prednisone in patients with metastatic CRPC.
- To estimate progression-free survival (PFS) as the primary endpoint.
Main Methods:
- A phase 2 randomized study comparing docetaxel/prednisone (control) versus LY2181308 plus docetaxel/prednisone (experimental).
- 154 patients with metastatic CRPC were enrolled in a 1:2 ratio.
- Secondary endpoints included overall survival (OS), prostate-specific antigen (PSA) response, pain, and quality of life scores.
Main Results:
- Median PFS was 8.64 months in the experimental arm versus 9.00 months in the control arm (p=0.755).
- Median OS was 27.04 months in the experimental arm versus 29.04 months in the control arm (p=0.838).
- PSA response, pain, and quality of life scores were similar between groups. Higher rates of neutropenia, anemia, thrombocytopenia, and neuropathy were observed in the experimental arm.
Conclusions:
- The addition of LY2181308 to docetaxel/prednisone did not demonstrate a significant improvement in PFS or OS for metastatic CRPC.
- The combination therapy showed similar efficacy to the standard treatment but with a numerically higher incidence of adverse events.
Related Concept Videos
02:56Treatment Resistant Cancers
02:57Targeted Cancer Therapies
There are several types of targeted therapies against...
02:49Cancer Therapies
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...