Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer

Event-free survival

Time frame · From randomization to disease progression or death, up to 5 years

The event-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 (clinical progression, biochemical progression, death)

Overall survival

Time frame · From randomization to death from any cause, up to 10 years

The overall survival is the length of time from randomization that patients enrolled in the study are still alive.

Metastases-free survival

Time frame · From randomization to metastases onset, up to 10 years

The metastases-free survival is the length of time during and after the treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body.

Acute or chronic toxicity

Time frame · Throughout study completion, up to 10 years

The National Cancer Institute-Common Terminology Criteria for Adverse Events version 3 (NCI-CTCAE v3.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale will assess the severity of sensory neuropathic disorders, this derivative into 5 grades determined by the investigator.

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

Time frame · At baseline, 2 years, and 5 years

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.

Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25)

Time frame · At baseline, 2 years, and 5 years

This EORTC prostate cancer specific questionnaire is intended to supplement the QLQ-C30. The prostate cancer module is a 25-item questionnaire designed for use among patients with localized and metastatic prostate cancer. It includes subscales assessing urinary symptoms (9 items), bowel symptoms (4 items), treatment-related symptoms (6 items), and sexual functioning (6 items). Using a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), patients indicate the degree to which they have experienced symptoms.

Functional dependence in patients over 75 years old

Time frame · At baseline, 2 years, and 5 years

The Lawton Instrumental Activities of Daily Living (IADL) Scale is a self-reported questionnaire to assess independent living skills for older adults. This questionnaire, composed of 31 questions organized into 8 domains (ability to use telephone, shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications, and ability to handle finances), is designed to identify improvement or deterioration of a person functioning over time. Each domain is scored 0-1 for a summary score ranging from 0 (low function, dependent) to 8 (high function, independent).