Prostate Cancer, Prostatic Cancer, Prostate Neoplasms, Prostatic Neoplasms, Cancer of the Prostate
Conditions
Keywords
Prostate Cancer, CyberKnife, Stereotactic Radiosurgery, Radiotherapy, Radiation, Prostate Tumor, Prostate Surgery
Brief summary
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
Detailed description
The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.
Interventions
RADIATIONCyberKnife Stereotactic Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
Sponsors
Accuray Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be at least 18 years of age * Histologically proven prostate adenocarcinoma * Patients belonging in one of the following risk groups: Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and Prostate Specific Antigen (PSA) ≤ 10, or Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10 or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml * Prostate volume: ≤ 100 cc * Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion criteria
* Prior prostatectomy or cryotherapy of the prostate * Prior radiotherapy to the prostate or lower pelvis * Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion * Chemotherapy for a malignancy in the last 5 years * History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years. * Hormone ablation for two months prior to enrollment, or during treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events \[AE\]) observed during the 5 years following CyberKnife (CK) treatment for prostate cancer. Kaplan Meier estimates for 5-yr and 10-yr are reported. Adverse events occurring within 3 months of treatment were categorized as acute toxicities, and those developing after 3 months were considered late toxicities. The rates were determined using the first Grade 3 or higher adverse event per patient, reported as possibly, probably, or definitely related to CK treatment. The Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 was used to determine the Grade or severity of adverse events in this study, with Grade 3 being severe or medically significant but not immediately life-threatening, Grade 4 being life-threatening and Grade 5 being death related to the adverse event. |
| Biochemical Disease-Free Survival (bDFS) | Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix definition, following CyberKnife treatment. Kaplan Meier estimates for 5-yr and 10-yr are reported. The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patient's lowest PSA value (nadir) + 2 ng/mL as an indicator of disease recurrence. The percentage of patients who did not have such a PSA rise or receive any interventional therapy to treat prostate cancer are reported below. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided. |
| Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided. |
| Disease Control and Survival Outcomes | Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | To determine the rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival following CyberKnife treatment in prostate cancer patients. Kaplan Meier estimates for 5-yr and 10-yr are reported. |
| Quality of Life Assessments: EPIC-26 Sexual | Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided. |
| Quality of Life Assessments: EPIC-26 Bowel | Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided. |
| Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | AUA-SI is a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms with scores ranging from 0 (no symptom) to 5 (symptom occurs almost always). Total score: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CyberKnife Stereotactic Radiosurgery 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction | 310 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 24 |
| Overall Study | Lost to Follow-up | 72 |
Baseline characteristics
| Characteristic | CyberKnife Stereotactic Radiosurgery |
|---|---|
| Age, Continuous | 67.6 years |
| American Joint Committee on Cancer (AJCC) 6th Edition Risk Group Intermediate: CS T1b-T2b, and Gleason 2-6, PSA ≤ 20 ng/ml | 37 Participants |
| American Joint Committee on Cancer (AJCC) 6th Edition Risk Group Intermediate: CS T1b-T2b and Gleason 7, PSA ≤ 10 ng/ml | 100 Participants |
| American Joint Committee on Cancer (AJCC) 6th Edition Risk Group Intermediate: CS T2b, Gleason 2-6, PSA ≤ 10 ng/ml | 1 Participants |
| American Joint Committee on Cancer (AJCC) 6th Edition Risk Group Low: Clinical Stage (CS) T1b-T2a, Gleason 2-6, Prostate Specific Antigen (PSA) ≤ 10 ng/ml | 172 Participants |
| Clinical Stage (Tumor) T1b = Tumor incidental histological finding in >5% of tissue resected | 3 Participants |
| Clinical Stage (Tumor) T1c = Tumor identified by needle biopsy found in one or both sides, but not palpable | 244 Participants |
| Clinical Stage (Tumor) T2a = Tumor involves ½ of one side or less | 54 Participants |
| Clinical Stage (Tumor) T2b = Tumor involves >½ of one side but not both sides | 9 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction | 293 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 = Restricted in physically strenuous activity | 10 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 = Capable of all selfcare but unable to carry out any work activities | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 3 = Capable of only limited selfcare | 1 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Unreported | 6 Participants |
| Prostate Specific Antigen (PSA) | 5.53 ng/mL |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black/African American | 18 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants |
| Race/Ethnicity, Customized White | 280 Participants |
| Region of Enrollment United States | 310 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 310 Participants |
| Total Gleason Score Gleason 2 - 6 | 181 Participants |
| Total Gleason Score Gleason 7 | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 21 / 310 |
| other Total, other adverse events | 302 / 310 |
| serious Total, serious adverse events | 34 / 310 |
Outcome results
Primary
Biochemical Disease-Free Survival (bDFS)
To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix definition, following CyberKnife treatment. Kaplan Meier estimates for 5-yr and 10-yr are reported. The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patient's lowest PSA value (nadir) + 2 ng/mL as an indicator of disease recurrence. The percentage of patients who did not have such a PSA rise or receive any interventional therapy to treat prostate cancer are reported below.
Time frame: Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CyberKnife Stereotactic Radiosurgery | Biochemical Disease-Free Survival (bDFS) | Probability of remaining disease-free at 5 years post-CyberKnife treatment | 97.3 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Biochemical Disease-Free Survival (bDFS) | Probability of remaining disease-free at 10 years post-CyberKnife treatment | 91.7 percentage of participants |
Primary
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events \[AE\]) observed during the 5 years following CyberKnife (CK) treatment for prostate cancer. Kaplan Meier estimates for 5-yr and 10-yr are reported. Adverse events occurring within 3 months of treatment were categorized as acute toxicities, and those developing after 3 months were considered late toxicities. The rates were determined using the first Grade 3 or higher adverse event per patient, reported as possibly, probably, or definitely related to CK treatment. The Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 was used to determine the Grade or severity of adverse events in this study, with Grade 3 being severe or medically significant but not immediately life-threatening, Grade 4 being life-threatening and Grade 5 being death related to the adverse event.
Time frame: Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CyberKnife Stereotactic Radiosurgery | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Acute GI Grade 3+ event(s) | 0 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Acute GU Grade 3+ event(s) | 0 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Late GI Grade 3+ events 5 years post treatment | 0 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Late GU Grade 3+ events 5 years post treatment | 1.5 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Late GI Grade 3+ event(s) at 10 years post CK treatment | 0 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Late GU Grade 3+ event(s) at 10 years post CK treatment | 1.5 percentage of participants |
Secondary
Disease Control and Survival Outcomes
To determine the rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival following CyberKnife treatment in prostate cancer patients. Kaplan Meier estimates for 5-yr and 10-yr are reported.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CyberKnife Stereotactic Radiosurgery | Disease Control and Survival Outcomes | Probability of Overall survival at 10 years post-CyberKnife treatment | 83.8 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Disease Control and Survival Outcomes | Probability of remaining free from Local Failure at 5 years post-CyberKnife treatment | 99.7 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Disease Control and Survival Outcomes | Probability of remaining free from Local Failure at 10 years post-CyberKnife treatment | 96.4 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Disease Control and Survival Outcomes | Probability of remaining free from Distant Failure at 5 years post-CyberKnife treatment | 99.3 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Disease Control and Survival Outcomes | Probability of remaining free from Distant Failure at 10 years post-CyberKnife treatment | 98.6 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Disease Control and Survival Outcomes | Probability of remaining free from disease at 5 years post-CyberKnife treatment | 97.3 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Disease Control and Survival Outcomes | Probability of remaining free from disease at 10 years post-CyberKnife treatment | 90.1 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Disease Control and Survival Outcomes | Probability of remaining free from prostate cancer at 5 years post-CyberKnife treatment | 100 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Disease Control and Survival Outcomes | Probability of remaining free from prostate cancer at 10 years post-CyberKnife treatment | 100 percentage of participants |
| CyberKnife Stereotactic Radiosurgery | Disease Control and Survival Outcomes | Probability of Overall survival at 5 years post-CyberKnife treatment | 95.7 percentage of participants |
Secondary
Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)
AUA-SI is a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms with scores ranging from 0 (no symptom) to 5 (symptom occurs almost always). Total score: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Population: AUA questionnaires were completed by patients for milestone follow-up visits, with 306/310 patients completing a baseline questionnaire. All questions needed to be completed in order to calculate the score. Scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | Baseline | 7.58 score on a scale | Standard Deviation 5.97 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | Last Day of Treatment | 12.53 score on a scale | Standard Deviation 8.11 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 1 Week Post Treatment | 14.13 score on a scale | Standard Deviation 8.29 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 1 Month Post Treatment | 11.64 score on a scale | Standard Deviation 7.3 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 3 Months Post Treatment | 7.53 score on a scale | Standard Deviation 5.54 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 6 Months Post Treatment | 7.20 score on a scale | Standard Deviation 5.71 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 12 Months Post Treatment | 8.49 score on a scale | Standard Deviation 6.48 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 18 Months Post Treatment | 7.84 score on a scale | Standard Deviation 6.27 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 24 Months Post Treatment | 7.32 score on a scale | Standard Deviation 5.69 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 36 Months Post Treatment | 6.59 score on a scale | Standard Deviation 5.73 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 48 Months Post Treatment | 6.41 score on a scale | Standard Deviation 5.9 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 60 Months Post Treatment | 6.13 score on a scale | Standard Deviation 6.17 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 72 Months Post Treatment | 5.62 score on a scale | Standard Deviation 5.93 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 84 Months Post Treatment | 5.77 score on a scale | Standard Deviation 5.85 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 96 Months Post Treatment | 4.97 score on a scale | Standard Deviation 6.25 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 108 Months Post Treatment | 4.60 score on a scale | Standard Deviation 5.35 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 120 Months Post Treatment | 4.79 score on a scale | Standard Deviation 5.33 |
Secondary
Quality of Life Assessments: EPIC-26 Bowel
EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Population: EPIC questionnaires were completed by patients at follow-up visits, with 300/310 patients completing a baseline questionnaire. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | Baseline | 94.88 score on a scale | Standard Deviation 9.66 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | 1 Month Post Treatment | 83.47 score on a scale | Standard Deviation 18.83 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | 6 Months Post Treatment | 91.61 score on a scale | Standard Deviation 13.42 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | 12 Months Post Treatment | 90.12 score on a scale | Standard Deviation 14.6 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | 24 Months Post Treatment | 92.18 score on a scale | Standard Deviation 13 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | 36 Months Post Treatment | 92.88 score on a scale | Standard Deviation 11.67 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | 48 Months Post Treatment | 92.52 score on a scale | Standard Deviation 12.89 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | 60 Months Post Treatment | 92.42 score on a scale | Standard Deviation 12.63 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | 72 Months Post Treatment | 94.31 score on a scale | Standard Deviation 9.79 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | 84 Months Post Treatment | 94.29 score on a scale | Standard Deviation 10.08 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | 96 Months Post Treatment | 93.44 score on a scale | Standard Deviation 9.46 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | 108 Months Post Treatment | 92.89 score on a scale | Standard Deviation 9.73 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Bowel | 120 Months Post Treatment | 93.77 score on a scale | Standard Deviation 8.93 |
Secondary
Quality of Life Assessments: EPIC-26 Sexual
EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Population: EPIC questionnaires were completed by patients at follow-up visits, with 300/310 patients completing a baseline questionnaire. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | Baseline | 56.79 score on a scale | Standard Deviation 31.95 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | 1 Month Post Treatment | 53.74 score on a scale | Standard Deviation 31.47 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | 6 Months Post Treatment | 53.74 score on a scale | Standard Deviation 33.49 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | 12 Months Post Treatment | 50.19 score on a scale | Standard Deviation 32.83 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | 24 Months Post Treatment | 47.71 score on a scale | Standard Deviation 32.27 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | 36 Months Post Treatment | 47.31 score on a scale | Standard Deviation 32.36 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | 48 Months Post Treatment | 46.82 score on a scale | Standard Deviation 31.6 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | 60 Months Post Treatment | 42.88 score on a scale | Standard Deviation 31.45 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | 72 Months Post Treatment | 47.66 score on a scale | Standard Deviation 33.93 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | 84 Months Post Treatment | 48.12 score on a scale | Standard Deviation 34.47 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | 96 Months Post Treatment | 44.16 score on a scale | Standard Deviation 30.34 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | 108 Months Post Treatment | 43.36 score on a scale | Standard Deviation 31.36 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Sexual | 120 Months Post Treatment | 50.13 score on a scale | Standard Deviation 31.08 |
Secondary
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Population: EPIC questionnaires were completed by patients at follow-up visits, with 300/310 patients completing a baseline questionnaire. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | Baseline | 87.85 score on a scale | Standard Deviation 12.56 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 1 Month Post Treatment | 75.20 score on a scale | Standard Deviation 18.37 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 6 Months Post Treatment | 87.82 score on a scale | Standard Deviation 13.76 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 12 Months Post Treatment | 84.29 score on a scale | Standard Deviation 16.57 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 24 Months Post Treatment | 87.43 score on a scale | Standard Deviation 13.63 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 36 Months Post Treatment | 89.64 score on a scale | Standard Deviation 11.85 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 48 Months Post Treatment | 88.76 score on a scale | Standard Deviation 13.45 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 60 Months Post Treatment | 90.36 score on a scale | Standard Deviation 12.66 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 72 Months Post Treatment | 92.57 score on a scale | Standard Deviation 10.41 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 84 Months Post Treatment | 92.11 score on a scale | Standard Deviation 10.65 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 96 Months Post Treatment | 90.77 score on a scale | Standard Deviation 12.29 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 108 Months Post Treatment | 91.70 score on a scale | Standard Deviation 9.78 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 120 Months Post Treatment | 92.28 score on a scale | Standard Deviation 9.24 |
Secondary
Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence
EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Population: EPIC questionnaires were completed by patients at follow-up visits, with 300/310 patients completing a baseline questionnaire. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | Baseline | 94.03 score on a scale | Standard Deviation 11.69 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 1 Month Post Treatment | 89.30 score on a scale | Standard Deviation 16.13 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 6 Months Post Treatment | 92.08 score on a scale | Standard Deviation 14.7 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 12 Months Post Treatment | 88.49 score on a scale | Standard Deviation 17.16 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 24 Months Post Treatment | 89.03 score on a scale | Standard Deviation 18.3 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 36 Months Post Treatment | 89.23 score on a scale | Standard Deviation 18.33 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 48 Months Post Treatment | 88.39 score on a scale | Standard Deviation 17.85 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 60 Months Post Treatment | 89.04 score on a scale | Standard Deviation 17.36 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 72 Months Post Treatment | 89.84 score on a scale | Standard Deviation 19.18 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 84 Months Post Treatment | 89.46 score on a scale | Standard Deviation 17.42 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 96 Months Post Treatment | 90.79 score on a scale | Standard Deviation 15.96 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 108 Months Post Treatment | 90.28 score on a scale | Standard Deviation 17.13 |
| CyberKnife Stereotactic Radiosurgery | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 120 Months Post Treatment | 89.42 score on a scale | Standard Deviation 17.15 |