Prostate Cancer
Conditions
Keywords
Post-prostatectomy, Enzalutamide, STEEL
Brief summary
Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.
Detailed description
PRIMARY OBJECTIVE: To determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog, will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.
Interventions
RADIATIONRadiation Therapy
daily fractions
DRUGEnzalutamide
tablet
DRUGBicalutamide
tablet
DRUGGnRH analog
Injection
Sponsors
Pfizer
Astellas Pharma Inc
RTOG Foundation, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically (histologically) proven adenocarcinoma confirmed by prostatectomy performed within 10 years prior to registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted. * Prostate-specific antigen (PSA) level (≥ 0.2 ng/mL) within 120 days prior to registration. Patients must have a PSA ≥ 0.2 ng/mL prior to starting ADT. For patients being followed by an ultrasensitive PSA assay, a serum PSA concentration of ≥ 0.10 ng/mL will be considered eligible. * GnRH analog may be started no more than 42 days prior study entry. * Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration. * Platelet count ≥ 75,000 x 10\^9/µL independent of transfusion and/or growth factors within 90 days prior to registration. * At least 1 of the following aggressive features: * Gleason score of 8-10 (note any Gleason score is eligible) * Seminal vesicle invasion (SVI) (note any pT stage American Joint Committee on Cancer (AJCC) v8.0 is eligible but a pT stage ≥ pT3b is considered aggressive) * Locoregional node involvement at radical prostatectomy (RP) (pN1) * Persistently elevated PSA post-RP nadir (PEPP) defined as PSA \> 0.1 ng/mL after radical prostatectomy * PSA ≥ 0.7 ng/mL * Serum albumin ≥ 3.0 g/dL within 90 days prior to registration * Glomerular filtration rate (GFR) ≥35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to registration. * Serum total bilirubin ≤1.5 × upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \>1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject is eligible) within 90 days prior to registration. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<2.5 × ULN within 90 days prior to registration. * History and physical with Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 or within 90 days prior to registration.
Exclusion criteria
* Definitive clinical or radiologic evidence of metastatic disease with the exception of locoregional lymph nodes. * Prior invasive malignancy (except non-melanomatous skin cancer carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years). * Prior systemic chemotherapy for the study cancer. Note: prior chemotherapy for a different cancer is allowable. * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. * History of any of the following: * Documented inflammatory bowel disease * Transmural myocardial infarction within the last 4 months prior to registration. * New York Heart Association Functional Classification III/IV within 4 months prior to registration. * Unstable angina and/or congestive heart failure requiring hospitalization within the last 4 months prior to registration * History of loss of consciousness or transient ischemic attack within 12 months prior to randomization * History of seizure disorder or condition that may predispose to seizure (e.g. prior cortical stroke or significant brain trauma) * History of uncontrolled hypertension defined as a sustained systolic blood pressure in excess of 150 mmHg or a sustained diastolic blood pressure in excess of 90 mmHg despite optimized antihypertensive therapy. * History of repeated falls and fractures over the past 12 months that in the opinion of the treating investigator would put the patient at risk for poor bone outcomes from androgen receptor targeted therapy * Known gastrointestinal disorder affecting absorption of oral medications. * Active uncontrolled infection defined as an identified infectious condition that requires active therapy that has not yet been completed. * HIV positive patients with CD4 count \< 200 cells/microliter within 30 days prior to registration OR HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count. Note: HIV testing is not required for eligibility for this protocol as it is self-reported. This exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive and/or interact with HAART.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Alive Without Progression (Progression-Free Survival) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Alternative Biochemical Failure | 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 | 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 | 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 | 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) | 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 | 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 | 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. |
| Percentage of Participants With Biochemical Failure | 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. |
| 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] | 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. |
| Change From Baseline to One Year After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score] | Baseline and one year 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 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. |
| Change From Baseline to Two Years After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score] | Baseline, 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 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. |
| Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | From randomization to death or last known follow-up. Median follow-up time at the time of analysis was 33.1 months. | Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
| Number of Participants Any Adverse Event Occuring Within 30 Days Following the End of Treatment | From randomization to 30 days after the 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. | Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
| Number of Participants With Any Grade 3+ Adverse Event Occuring After 30 Days Following the End of RT | From 31 days after the end of RT to death or last known follow-up. Median follow-up was 33.1 months. 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. | Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
| Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | End of RT, one and two years after the 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. | PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's usual or daily activities (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate Severity, Frequency, or Interference. All scores are compared between arms; statistical analysis results are entered for p-values \< 0.05. |
| Change From Baseline to Two Years After End of RT in the EQ-5D-5L Index Score | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SRT + Standard ADT Standard ADT: 24 months of GnRH analog (any formulation) with optional 1-4 months of bicalutamide (50 mg/day).
SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost. | 98 |
| SRT + Enhanced ADT Enhanced ADT: 24 months of GnRH analog (any formulation) with 24 months of enzalutamide (160 mg/day).
SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost. | 90 |
| Total | 188 |
Baseline characteristics
| Characteristic | SRT + Standard ADT | SRT + Enhanced ADT | Total |
|---|---|---|---|
| Age, Continuous | 65 years | 63 years | 64 years |
| Baseline PSA | 0.565 ng/mL | 0.785 ng/mL | 0.605 ng/mL |
| ECOG (Eastern Cooperative Oncology Group) Performance Status Scale 0 | 90 Participants | 77 Participants | 167 Participants |
| ECOG (Eastern Cooperative Oncology Group) Performance Status Scale 1 | 8 Participants | 13 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 4 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 89 Participants | 82 Participants | 171 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 5 Participants |
| Gleason Score 10 | 1 Participants | 0 Participants | 1 Participants |
| Gleason Score 6 | 1 Participants | 0 Participants | 1 Participants |
| Gleason Score 7 | 39 Participants | 34 Participants | 73 Participants |
| Gleason Score 8 | 11 Participants | 5 Participants | 16 Participants |
| Gleason Score 9 | 46 Participants | 51 Participants | 97 Participants |
| Number of aggressive features 1 | 30 Participants | 23 Participants | 53 Participants |
| Number of aggressive features > 1 | 68 Participants | 67 Participants | 135 Participants |
| Pathologic N-Stage N0 | 63 Participants | 63 Participants | 126 Participants |
| Pathologic N-Stage N1 | 20 Participants | 21 Participants | 41 Participants |
| Pathologic N-Stage NX | 15 Participants | 6 Participants | 21 Participants |
| Pathologic T-Stage T2 | 21 Participants | 15 Participants | 36 Participants |
| Pathologic T-Stage T3 | 2 Participants | 2 Participants | 4 Participants |
| Pathologic T-Stage T3a | 31 Participants | 28 Participants | 59 Participants |
| Pathologic T-Stage T3b | 42 Participants | 43 Participants | 85 Participants |
| Pathologic T-Stage T4 | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 15 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) White | 85 Participants | 67 Participants | 152 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 98 Participants | 90 Participants | 188 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 98 | 0 / 90 |
| other Total, other adverse events | 89 / 98 | 87 / 89 |
| serious Total, serious adverse events | 11 / 98 | 17 / 89 |
Outcome results
Primary
Percentage of Participants Alive Without Progression (Progression-Free Survival)
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.
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.
Population: Randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SRT + Standard ADT | Percentage of Participants Alive Without Progression (Progression-Free Survival) | 1 year | 38.3 percentage of participants |
| SRT + Standard ADT | Percentage of Participants Alive Without Progression (Progression-Free Survival) | 2 years | 32.1 percentage of participants |
| SRT + Enhanced ADT | Percentage of Participants Alive Without Progression (Progression-Free Survival) | 1 year | 45.5 percentage of participants |
| SRT + Enhanced ADT | Percentage of Participants Alive Without Progression (Progression-Free Survival) | 2 years | 38.3 percentage of participants |
Comparison: After protocol amendments, the 3-year PFS rate of the standard arm was expected to be 24%. Assuming a hazard ratio of 0.65 (treatment/control) results in a hypothesized 3-year PFS rate of 39.5% on the enhanced ADT arm. A one-sided log-rank test with alpha=0.10 at 80% statistical power was calculated to require 101 events from 170 patients, taking into account expected accrual rate and follow-up time.p-value: 0.067180% CI: [0.61, 0.96]Log Rank
Secondary
Change From Baseline to End of RT in the 5-level European Quality of Life Questionnaire (EQ-5D-5L) Index Score
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.
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.
Population: Randomized participants who consented to the quality of life study component and who have baseline and end of RT data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRT + Standard ADT | Change From Baseline to End of RT in the 5-level European Quality of Life Questionnaire (EQ-5D-5L) Index Score | 0.0 score on a scale | Standard Deviation 0.1 |
| SRT + Enhanced ADT | Change From Baseline to End of RT in the 5-level European Quality of Life Questionnaire (EQ-5D-5L) Index Score | 0.0 score on a scale | Standard Deviation 0.1 |
p-value: 0.7184t-test, 2 sided
Secondary
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]
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.
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.
Population: Randomized participants who consented to the quality of life study component and who have baseline and end of RT data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRT + Standard ADT | 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] | 3.4 score on a scale | Standard Deviation 7.8 |
| SRT + Enhanced ADT | 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] | 6.8 score on a scale | Standard Deviation 6.4 |
p-value: 0.006258t-test, 2 sided
Secondary
Change From Baseline to One Year After End of RT in the EQ-5D-5L Index Score
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.
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.
Population: Randomized participants who consented to the quality of life study component and who have baseline and one year after end of RT data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRT + Standard ADT | Change From Baseline to One Year After End of RT in the EQ-5D-5L Index Score | 0.0 score on a scale | Standard Deviation 0.1 |
| SRT + Enhanced ADT | Change From Baseline to One Year After End of RT in the EQ-5D-5L Index Score | 0.0 score on a scale | Standard Deviation 0.1 |
p-value: 0.5934t-test, 2 sided
Secondary
Change From Baseline to One Year After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score]
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.
Time frame: Baseline and one year 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.
Population: Randomized participants who consented to the quality of life study component and who have baseline and end of RT data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRT + Standard ADT | Change From Baseline to One Year After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score] | 4.0 score on a scale | Standard Deviation 7.4 |
| SRT + Enhanced ADT | Change From Baseline to One Year After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score] | 7.0 score on a scale | Standard Deviation 8 |
p-value: 0.0263t-test, 2 sided
Secondary
Change From Baseline to Two Years After End of RT in the EQ-5D-5L Index Score
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.
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.
Population: Randomized participants who consented to the quality of life study component and who have baseline and two year after end of RT data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRT + Standard ADT | Change From Baseline to Two Years After End of RT in the EQ-5D-5L Index Score | 0.0 score on a scale | Standard Deviation 0.1 |
| SRT + Enhanced ADT | Change From Baseline to Two Years After End of RT in the EQ-5D-5L Index Score | 0.0 score on a scale | Standard Deviation 0.1 |
p-value: 0.7129t-test, 2 sided
Secondary
Change From Baseline to Two Years After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score]
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.
Time frame: Baseline, 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.
Population: Randomized participants who consented to the quality-of-life study component and who have baseline and two years after end of RT data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRT + Standard ADT | Change From Baseline to Two Years After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score] | 4.0 score on a scale | Standard Deviation 7.5 |
| SRT + Enhanced ADT | Change From Baseline to Two Years After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score] | 5.0 score on a scale | Standard Deviation 7.8 |
p-value: 0.4599t-test, 2 sided
Secondary
Number of Participants Any Adverse Event Occuring Within 30 Days Following the End of Treatment
Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Time frame: From randomization to 30 days after the 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.
Population: Randomized participants who started protocol treatment and were assessed for adverse events.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SRT + Standard ADT | Number of Participants Any Adverse Event Occuring Within 30 Days Following the End of Treatment | 86 Participants |
| SRT + Enhanced ADT | Number of Participants Any Adverse Event Occuring Within 30 Days Following the End of Treatment | 83 Participants |
p-value: 0.313895% CI: [0.62, 4.41]Regression, Logistic
Secondary
Number of Participants by Highest Grade Adverse Event Reported CTCAE v5
Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Time frame: From randomization to death or last known follow-up. Median follow-up time at the time of analysis was 33.1 months.
Population: Randomized participants who started protocol treatment and were assessed for adverse events.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SRT + Standard ADT | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | None | 8 Participants |
| SRT + Standard ADT | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | Grade 1 | 19 Participants |
| SRT + Standard ADT | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | Grade 2 | 38 Participants |
| SRT + Standard ADT | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | Grade 3 | 27 Participants |
| SRT + Standard ADT | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | Grade 4 | 6 Participants |
| SRT + Standard ADT | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | Grade 5 | 0 Participants |
| SRT + Enhanced ADT | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | Grade 4 | 6 Participants |
| SRT + Enhanced ADT | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | None | 3 Participants |
| SRT + Enhanced ADT | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | Grade 3 | 39 Participants |
| SRT + Enhanced ADT | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | Grade 1 | 9 Participants |
| SRT + Enhanced ADT | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | Grade 5 | 0 Participants |
| SRT + Enhanced ADT | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | Grade 2 | 32 Participants |
Secondary
Number of Participants With Any Grade 3+ Adverse Event Occuring After 30 Days Following the End of RT
Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Time frame: From 31 days after the end of RT to death or last known follow-up. Median follow-up was 33.1 months. 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.
Population: Randomized participants who started protocol treatment, were assessed for adverse events, and alive 30 days after radiation therapy ended.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SRT + Standard ADT | Number of Participants With Any Grade 3+ Adverse Event Occuring After 30 Days Following the End of RT | 27 Participants |
| SRT + Enhanced ADT | Number of Participants With Any Grade 3+ Adverse Event Occuring After 30 Days Following the End of RT | 30 Participants |
p-value: 0.3889Chi-squared
Secondary
Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3
PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's usual or daily activities (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate Severity, Frequency, or Interference. All scores are compared between arms; statistical analysis results are entered for p-values \< 0.05.
Time frame: End of RT, one and two years after the 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.
Population: Randomized participants with PRO-CTCAE data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Decreased Sexual Interest Severity | 42 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Fatigue Interference | 31 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Urinary Urgency Frequency | 38 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Urinary Urgency Interference | 23 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Frequent Urination Frequency | 46 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Frequent Urination Interference | 25 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Urine Control Loss Frequency | 39 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Urine Control Loss Interference | 22 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Erection Difficulty Severity | 40 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Ejaculation Problems Frequency | 26 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Pain with Urination Severity | 4 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Breast Tenderness Severity | 7 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Hot Flashes Frequency | 56 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Hot Flashes Severity | 32 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Pain Frequency | 35 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Pain Severity | 21 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Pain Interference | 16 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Taste Changes Severity | 3 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Decreased Appetite Severity | 2 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Decreased Appetite Interference | 2 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Nausea Frequency | 8 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Nausea Severity | 7 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Constipation Severity | 13 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Loose Stool Frequency | 30 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Abdominal Pain Frequency | 19 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Abdominal Pain Severity | 13 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Abdominal Pain Interference | 10 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Bowel Movement Control Frequency | 9 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Bowel Movement Control Interference | 7 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Racing Heartbeat Frequency | 5 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Racing Heartbeat Severity | 3 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Itchy Skin Severity | 10 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Concentration Problems Severity | 9 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Concentration Problems Interference | 12 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Memory Problems Severity | 7 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Memory Problems Interference | 8 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Headache Frequency | 12 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Headache Severity | 5 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Headache Interference | 5 Participants |
| SRT + Standard ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Fatigue Severity | 29 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Headache Severity | 9 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Nausea Frequency | 8 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Fatigue Interference | 34 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Pain with Urination Severity | 6 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Racing Heartbeat Severity | 1 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Urinary Urgency Frequency | 37 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Nausea Severity | 3 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Urinary Urgency Interference | 25 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Memory Problems Interference | 11 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Frequent Urination Frequency | 45 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Constipation Severity | 9 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Frequent Urination Interference | 24 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Itchy Skin Severity | 3 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Urine Control Loss Frequency | 39 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Loose Stool Frequency | 19 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Urine Control Loss Interference | 28 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Fatigue Severity | 31 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Erection Difficulty Severity | 24 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Abdominal Pain Frequency | 14 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Ejaculation Problems Frequency | 18 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Concentration Problems Severity | 11 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Decreased Sexual Interest Severity | 33 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Abdominal Pain Severity | 9 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Breast Tenderness Severity | 7 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Headache Frequency | 9 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Hot Flashes Frequency | 63 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Abdominal Pain Interference | 7 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Hot Flashes Severity | 44 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Concentration Problems Interference | 11 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Pain Frequency | 33 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Bowel Movement Control Frequency | 5 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Pain Severity | 23 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Headache Interference | 6 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Pain Interference | 23 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Bowel Movement Control Interference | 5 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Taste Changes Severity | 8 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Memory Problems Severity | 11 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Decreased Appetite Severity | 6 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Racing Heartbeat Frequency | 6 Participants |
| SRT + Enhanced ADT | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | Decreased Appetite Interference | 4 Participants |
Comparison: Hot Flashes Frequencyp-value: 0.0461t-test, 2 sided
Comparison: Hot Flashes Severityp-value: 0.0181t-test, 2 sided
Secondary
Percentage of Participants Alive (Overall Survival)
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.
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.
Population: Randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SRT + Standard ADT | Percentage of Participants Alive (Overall Survival) | 96 Participants |
| SRT + Enhanced ADT | Percentage of Participants Alive (Overall Survival) | 90 Participants |
Secondary
Percentage of Participants With Alternative Biochemical Failure
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.
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.
Population: Randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SRT + Standard ADT | Percentage of Participants With Alternative Biochemical Failure | 1 year | 35.9 percentage of participants |
| SRT + Standard ADT | Percentage of Participants With Alternative Biochemical Failure | 2 years | 45.4 percentage of participants |
| SRT + Enhanced ADT | Percentage of Participants With Alternative Biochemical Failure | 1 year | 31.4 percentage of participants |
| SRT + Enhanced ADT | Percentage of Participants With Alternative Biochemical Failure | 2 years | 39.9 percentage of participants |
p-value: 0.161895% CI: [0.5, 1.12]Gray's
Secondary
Percentage of Participants With Biochemical Failure
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.
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.
Population: Randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SRT + Standard ADT | Percentage of Participants With Biochemical Failure | 1 year | 61.7 percentage of participants |
| SRT + Standard ADT | Percentage of Participants With Biochemical Failure | 2 years | 67.9 percentage of participants |
| SRT + Enhanced ADT | Percentage of Participants With Biochemical Failure | 1 year | 54.6 percentage of participants |
| SRT + Enhanced ADT | Percentage of Participants With Biochemical Failure | 2 years | 60.6 percentage of participants |
p-value: 0.11695% CI: [0.53, 1.07]Gray's
Secondary
Percentage of Participants With Distant Metastasis
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.
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.
Population: Randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SRT + Standard ADT | Percentage of Participants With Distant Metastasis | 6 Participants |
| SRT + Enhanced ADT | Percentage of Participants With Distant Metastasis | 1 Participants |
Secondary
Percentage of Participants With Hormone-refractory Disease
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.
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.
Population: Randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SRT + Standard ADT | Percentage of Participants With Hormone-refractory Disease | 0 Participants |
| SRT + Enhanced ADT | Percentage of Participants With Hormone-refractory Disease | 0 Participants |
Secondary
Percentage of Participants With Prostate Cancer Death
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.
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.
Population: Randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SRT + Standard ADT | Percentage of Participants With Prostate Cancer Death | 0 Participants |
| SRT + Enhanced ADT | Percentage of Participants With Prostate Cancer Death | 0 Participants |
Post Hoc
Percentage of Participants Alive Without Progression (Progression-Free Survival) [Alternate Definition]
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 PSA ≥ 0.2. Clinical failure is defined as either a local, regional, or distant failure.
Time frame: From randomization to first failure or last known follow-up. Medium follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported.
Population: Randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SRT + Standard ADT | Percentage of Participants Alive Without Progression (Progression-Free Survival) [Alternate Definition] | 1 year | 87.5 percentage of participants |
| SRT + Standard ADT | Percentage of Participants Alive Without Progression (Progression-Free Survival) [Alternate Definition] | 2 years | 78.8 percentage of participants |
| SRT + Enhanced ADT | Percentage of Participants Alive Without Progression (Progression-Free Survival) [Alternate Definition] | 2 years | 88.3 percentage of participants |
| SRT + Enhanced ADT | Percentage of Participants Alive Without Progression (Progression-Free Survival) [Alternate Definition] | 1 year | 91.9 percentage of participants |
p-value: 0.180% CI: [0.42, 0.91]Log Rank