Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy

Progression-free survival (PFS)

Time frame · 5 years

PFS is defined as the time from the date of randomization to the date of first evidence of loco-regional recurrences, or distant metastases, or death from any cause whichever occurs first, or the date of last known follow-up alive without any such events.

Cancer-specific overall survival

Time frame · 10 years

Cancer-specific overall survival is defined as the time from the date of randomization to the date of death related to prostate cancer or the date of last known follow-up alive.

Overall survival (OS)

Time frame · 10 years

OS is defined as the time from the date of randomization to the date of death from any cause or the date of last known follow-up alive.

Biochemical relapse-free survival

Time frame · 10 years

Biochemical relapse-free survival will be retrospectively defined by the interval between the date of randomization and the date of the first PSA elevation following the 6-months treatment in both arms (PSA ≥0.5 ng/mL confirmed by two consecutive PSA increases over a 2-month interval).

Time to castration resistance

Time frame · 10 years

The time to castration resistance is defined as the time from the date of randomization to the date of appearance of castration resistance defined in the European Association of Urology (EAU) guidelines.

Adverse events graded according to the NCI Common Terminology Criteria for Adverse Events version 5.0

Time frame · Throughout study completion, up to 10 years

The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.

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

Time frame · At baseline, 3 months, 6 months, every 6 months up to 5 years then every 12 months up to 10 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, 3 months, 6 months, every 6 months up to 5 years then every 12 months up to 10 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.

International Index of Erectile Function (IIEF-5)

Time frame · At baseline, 3 months, 6 months, every 6 months up to 5 years then every 12 months up to 10 years

International Index of Erectile Function (IIEF-5) is multidimensional, self-administered questionnaire composed of 15 questions that examine the 4 main domains of male sexual function (erectile function \[6 items\], orgasmic function \[2 items\], sexual desire \[2 items\], and intercourse satisfaction \[3 items\]) and overall satisfaction (2 items). Using a 6-point Likert scale (questions 1 to 10) and 5-point Likert scale (questions 15 to 15), patients indicate the degree to which they have experienced symptoms. The total score for each domain can therefore classifies the severity of erectile dysfunction into five categories: no (score 26-30), mild (22-25), mild to moderate (17-21), moderate (11-16), and severe (1-10) erectile dysfunction.

Lawton Instrumental Activities of Daily Living (IADL) Scale

Time frame · At baseline, 3 months, 6 months, every 6 months up to 5 years then every 12 months up to 10 years

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).