Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse

Clinical progression-free survival

时间窗: From randomization to disease progression or death, up to 15 years.

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).

Cancer progression as measured by ultrasound

时间窗: From randomization to disease progression, up to 15 years.

Defined as a decrease of at least 20% in prostate volume detected by ultrasound after the neo-adjuvant treatment

Quality of life questionnaire - Core 30 (QLQ-C30)

时间窗: At baseline, 3 months, and 1 year

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.

Progression-free survival

时间窗: From randomization to disease progression or death, up to 15 years.

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.

Biological response: Prostate-specific antigen (PSA) level

时间窗: 3 months

The biological response is defined as a non-detectable serum PSA level (\<0.1 ng/ml)

Overall survival

时间窗: From randomization to death from any cause, up to 15 years.

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.

Acute and late toxicity during the study

时间窗: Throughout study completion, up to 15 years.

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.