A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery

Percentage of Participants Alive Without Progression (Progression-Free Survival)

Time frame · From randomization to first failure or last known follow-up. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported.

Progression-free survival (PFS) is estimated by the Kaplan-Meier method. PFS time is measured from randomization to the date of first PFS failure (biochemical or clinical failure, initiation of new unplanned anticancer treatment, or death from any cause) or last known follow-up (censored). Analysis was to occur after progression or death was reported for 101 participants. Biochemical failure is defined as first post-RT detectable PSA (PSA ≥ 0.05). Clinical failure is defined as either a local, regional, or distant failure.

Percentage of Participants With Biochemical Failure

Time frame · From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported.

Biochemical failure is defined as the first detectable post-RT prostate-specific antigen (PSA) value (≥ 0.05) or the initiation of salvage hormone therapy. Failure rates are estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis.

Percentage of Participants With Alternative Biochemical Failure

Time frame · From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported.

Alternative biochemical failure is defined as first post-RT PSA ≥ 0.1 ng/mL or initiation of salvage hormone therapy. Failure rates are estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis.

Percentage of Participants With Hormone-refractory Disease

Time frame · From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months.

Hormone-refractory disease is defined as three rises in PSA during salvage androgen deprivation, with the date determined as the midway date between the last non-rising PSA and the first of the three rises. Failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with \< 10 events overall, such as this one, only the counts of participants with the event are provided.

Percentage of Participants With Distant Metastasis

Time frame · From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months.

Distant failure is defined as first radiographic evidence of distant metastasis (e.g., bone scan, computed tomography (CT), magnetic resonance imaging (MRI)). Failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with \< 10 events overall, such as this one, only the counts of participants with the event are provided.

Percentage of Participants With Prostate Cancer Death

Time frame · From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months.

Cause-specific mortality is defined as death due to prostate cancer. Failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with \< 10 events overall, such as this one, only the counts of participants with the event are provided.

Percentage of Participants Alive (Overall Survival)

Time frame · From randomization to death or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months.

Survival rates were to be estimated using the Kaplan-Meier method, censoring participants alive at time of analysis, but for endpoints with \< 10 events overall, such as this one, only counts are provided. In this case, the number of participants without event (death), which is the number of participants alive.

Change From Baseline to End of RT in the 5-level European Quality of Life Questionnaire (EQ-5D-5L) Index Score

Time frame · Baseline and end of radiation treatment (RT). End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

The EQ-5D-5L is a self-assessment questionnaire. The index score is computed from 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change score was calculated by subtracting baseline from later score, with a positive change score indicating improvement.

Change From Baseline to One Year After End of RT in the EQ-5D-5L Index Score

Time frame · Baseline and one year after end RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

The EQ-5D-5L is a self-assessment questionnaire. The index score is computed from 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change score was calculated by subtracting baseline from later score, with a positive change score indicating improvement.

Change From Baseline to Two Years After End of RT in the EQ-5D-5L Index Score

Time frame · Baseline and two years after end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

The EQ-5D-5L is a self-assessment questionnaire. The index score is computed from 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change score was calculated by subtracting baseline from later score, with a positive change score indicating improvement.

Change From Baseline to End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score]

Time frame · Baseline and end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks.

The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue.