Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CASODEX®
Bicalutamide · 7 trials · 3 indications
The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
The biological response is defined as a non-detectable serum PSA level (\<0.1 ng/ml)
Defined as a decrease of at least 20% in prostate volume detected by ultrasound after the neo-adjuvant treatment
The clinical progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (based on bone scintigraphy, pelvic scan, or MRI evaluation).
The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care.
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, based on raw height data (cm/year).
Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, calculated after adjustment for the chronological age of the patient (expressed as a standard deviation \[SD\] score).
| Arm | Type | Description |
|---|---|---|
| Chemotherapy | EXPERIMENTAL | - |
| Without Chemotherapy | ACTIVE_COMPARATOR | - |
| A | PLACEBO_COMPARATOR | - |
| B | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| 200 mg Casodex | EXPERIMENTAL | - |
| Bicalutamide with Anastrozole | OTHER | Bicalutamide in combination with Anastrozole |
| Name | Type | Description |
|---|---|---|
| bicalutamide | DRUG | - |
| Goserelin Acetate | DRUG | - |
| docetaxel | DRUG | - |
| Estramustine phosphate sodium | DRUG | - |
| acetylsalicylic acid | DRUG | - |
| conventional surgery | PROCEDURE | - |
| radiation therapy | RADIATION | - |
| Tamoxifen | DRUG | - |
| Placebo | DRUG | - |
| Anastrozole | DRUG | oral |
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Locally advanced disease or at high risk for relapse * No clinically or radiologically suspected metastases * Prior lymphadenectomy required * Meets at least 1 of the following criteria for poor prognosis: * ...
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Bicalutamide is used to treat prostate cancer, including non-metastatic prostate cancer and advanced prostate cancer. It has also been studied in precocious puberty. It is a small molecule developed by AstraZeneca PLC under the ticker AZN and has been evaluated in Phase 3 clinical trials.
Bicalutamide targets the androgen receptor, or AR, acting as an antagonist. By blocking the androgen receptor, it interferes with androgen signaling, which is relevant in prostate cancer, where androgens drive tumor growth. This mechanism underlies its use in prostate cancer treatment.
Bicalutamide is developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored Phase 3 clinical trials of the drug in prostate cancer, including studies conducted across North America, Europe, and other regions.
Bicalutamide has been evaluated in Phase 3 clinical trials. The trials listed are completed, with no active trials currently reported. It is an investigational agent in the context of these studies, and the available information does not indicate approval status.
Bicalutamide has been studied in completed Phase 3 trials including NCT00846976 in advanced prostate cancer, NCT00673205 and NCT00672282 in non-metastatic early prostate cancer, and NCT00657904 in early prostate cancer. These trials enrolled a total of 8,424 participants and were randomized, double-blind, and placebo-controlled.
Bicalutamide is also known as Casodex. The trade name Casodex appears in trial titles such as Casodex versus placebo in non-metastatic early prostate cancer, confirming that bicalutamide and Casodex refer to the same drug developed by AstraZeneca PLC.