Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Bicalutamide
Casodex · 8 trials · 4 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 |
| Casodex | DRUG | 150mg once daily |
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: * ...
Casodex is being studied in gynaecomastia, a condition of enlarged breast tissue in men. The Phase 2 trial NCT00637871 evaluated Casodex in patients with gynaecomastia and prostate cancer. Casodex is a small molecule developed by AstraZeneca PLC under the ticker AZN.
Casodex is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating Casodex in gynaecomastia.
Casodex is in Phase 2 clinical development for gynaecomastia. One Phase 2 trial, NCT00637871, has been completed. Casodex is investigational and has not been approved for gynaecomastia.
Casodex has been studied in one completed Phase 2 trial, NCT00637871, titled Casodex - Nolvadex Combination. The trial enrolled male participants with gynaecomastia and prostate cancer. It was randomized, double-blind, and active-controlled.