Trial Outcomes & Findings for CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution (NCT NCT00643994)
NCT ID: NCT00643994
Last Updated: 2023-05-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
379 participants
Primary outcome timeframe
Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Results posted on
2023-05-09
Participant Flow
Participant milestones
| Measure |
CyberKnife Stereotactic Radiosurgery
Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
Overall Study
STARTED
|
310
|
|
Overall Study
10-yr Follow up
|
69
|
|
Overall Study
COMPLETED
|
214
|
|
Overall Study
NOT COMPLETED
|
96
|
Reasons for withdrawal
| Measure |
CyberKnife Stereotactic Radiosurgery
Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
Overall Study
Death
|
24
|
|
Overall Study
Lost to Follow-up
|
72
|
Baseline Characteristics
CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution
Baseline characteristics by cohort
| Measure |
CyberKnife Stereotactic Radiosurgery
n=310 Participants
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
Age, Continuous
|
67.6 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
310 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
18 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
5 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
280 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
310 participants
n=93 Participants
|
|
Clinical Stage (Tumor)
T1b = Tumor incidental histological finding in >5% of tissue resected
|
3 Participants
n=93 Participants
|
|
Clinical Stage (Tumor)
T1c = Tumor identified by needle biopsy found in one or both sides, but not palpable
|
244 Participants
n=93 Participants
|
|
Clinical Stage (Tumor)
T2a = Tumor involves ½ of one side or less
|
54 Participants
n=93 Participants
|
|
Clinical Stage (Tumor)
T2b = Tumor involves >½ of one side but not both sides
|
9 Participants
n=93 Participants
|
|
Total Gleason Score
Gleason 2 - 6
|
181 Participants
n=93 Participants
|
|
Total Gleason Score
Gleason 7
|
129 Participants
n=93 Participants
|
|
Prostate Specific Antigen (PSA)
|
5.53 ng/mL
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 = Fully active, able to carry on all pre-disease performance without restriction
|
293 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 = Restricted in physically strenuous activity
|
10 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 = Capable of all selfcare but unable to carry out any work activities
|
0 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3 = Capable of only limited selfcare
|
1 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Unreported
|
6 Participants
n=93 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
n=93 Participants
|
|
American Joint Committee on Cancer (AJCC) 6th Edition Risk Group
Intermediate: CS T2b, Gleason 2-6, PSA ≤ 10 ng/ml
|
1 Participants
n=93 Participants
|
|
American Joint Committee on Cancer (AJCC) 6th Edition Risk Group
Intermediate: CS T1b-T2b, and Gleason 2-6, PSA ≤ 20 ng/ml
|
37 Participants
n=93 Participants
|
|
American Joint Committee on Cancer (AJCC) 6th Edition Risk Group
Intermediate: CS T1b-T2b and Gleason 7, PSA ≤ 10 ng/ml
|
100 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
CyberKnife Stereotactic Radiosurgery
n=310 Participants
Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
Probability of experiencing Acute GI Grade 3+ event(s)
|
0 percentage of participants
|
|
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
Probability of experiencing Acute GU Grade 3+ event(s)
|
0 percentage of participants
|
|
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
Probability of experiencing Late GI Grade 3+ events 5 years post treatment
|
0 percentage of participants
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
CyberKnife Stereotactic Radiosurgery
n=310 Participants
Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
Biochemical Disease-Free Survival (bDFS)
Probability of remaining disease-free at 5 years post-CyberKnife treatment
|
97.3 percentage of participants
|
|
Biochemical Disease-Free Survival (bDFS)
Probability of remaining disease-free at 10 years post-CyberKnife treatment
|
91.7 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
CyberKnife Stereotactic Radiosurgery
n=310 Participants
Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
Disease Control and Survival Outcomes
Probability of remaining free from Local Failure at 5 years post-CyberKnife treatment
|
99.7 percentage of participants
|
|
Disease Control and Survival Outcomes
Probability of remaining free from Local Failure at 10 years post-CyberKnife treatment
|
96.4 percentage of participants
|
|
Disease Control and Survival Outcomes
Probability of remaining free from Distant Failure at 5 years post-CyberKnife treatment
|
99.3 percentage of participants
|
|
Disease Control and Survival Outcomes
Probability of remaining free from Distant Failure at 10 years post-CyberKnife treatment
|
98.6 percentage of participants
|
|
Disease Control and Survival Outcomes
Probability of remaining free from disease at 5 years post-CyberKnife treatment
|
97.3 percentage of participants
|
|
Disease Control and Survival Outcomes
Probability of remaining free from disease at 10 years post-CyberKnife treatment
|
90.1 percentage of participants
|
|
Disease Control and Survival Outcomes
Probability of remaining free from prostate cancer at 5 years post-CyberKnife treatment
|
100 percentage of participants
|
|
Disease Control and Survival Outcomes
Probability of remaining free from prostate cancer at 10 years post-CyberKnife treatment
|
100 percentage of participants
|
|
Disease Control and Survival Outcomes
Probability of Overall survival at 5 years post-CyberKnife treatment
|
95.7 percentage of participants
|
|
Disease Control and Survival Outcomes
Probability of Overall survival at 10 years post-CyberKnife treatment
|
83.8 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
CyberKnife Stereotactic Radiosurgery
n=306 Participants
Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)
Baseline
|
7.58 score on a scale
Standard Deviation 5.97
|
|
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
|
|
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
|
|
Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)
1 Month Post Treatment
|
11.64 score on a scale
Standard Deviation 7.30
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)
48 Months Post Treatment
|
6.41 score on a scale
Standard Deviation 5.90
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
CyberKnife Stereotactic Radiosurgery
n=300 Participants
Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence
Baseline
|
94.03 score on a scale
Standard Deviation 11.69
|
|
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
|
|
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 14.70
|
|
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
|
|
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 18.30
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
CyberKnife Stereotactic Radiosurgery
n=300 Participants
Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
Baseline
|
87.85 score on a scale
Standard Deviation 12.56
|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
1 Month Post Treatment
|
75.20 score on a scale
Standard Deviation 18.37
|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
6 Months Post Treatment
|
87.82 score on a scale
Standard Deviation 13.76
|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
12 Months Post Treatment
|
84.29 score on a scale
Standard Deviation 16.57
|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
24 Months Post Treatment
|
87.43 score on a scale
Standard Deviation 13.63
|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
36 Months Post Treatment
|
89.64 score on a scale
Standard Deviation 11.85
|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
48 Months Post Treatment
|
88.76 score on a scale
Standard Deviation 13.45
|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
60 Months Post Treatment
|
90.36 score on a scale
Standard Deviation 12.66
|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
72 Months Post Treatment
|
92.57 score on a scale
Standard Deviation 10.41
|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
84 Months Post Treatment
|
92.11 score on a scale
Standard Deviation 10.65
|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
96 Months Post Treatment
|
90.77 score on a scale
Standard Deviation 12.29
|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
108 Months Post Treatment
|
91.70 score on a scale
Standard Deviation 9.78
|
|
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
120 Months Post Treatment
|
92.28 score on a scale
Standard Deviation 9.24
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
CyberKnife Stereotactic Radiosurgery
n=300 Participants
Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
Quality of Life Assessments: EPIC-26 Bowel
Baseline
|
94.88 score on a scale
Standard Deviation 9.66
|
|
Quality of Life Assessments: EPIC-26 Bowel
1 Month Post Treatment
|
83.47 score on a scale
Standard Deviation 18.83
|
|
Quality of Life Assessments: EPIC-26 Bowel
6 Months Post Treatment
|
91.61 score on a scale
Standard Deviation 13.42
|
|
Quality of Life Assessments: EPIC-26 Bowel
12 Months Post Treatment
|
90.12 score on a scale
Standard Deviation 14.60
|
|
Quality of Life Assessments: EPIC-26 Bowel
24 Months Post Treatment
|
92.18 score on a scale
Standard Deviation 13.00
|
|
Quality of Life Assessments: EPIC-26 Bowel
36 Months Post Treatment
|
92.88 score on a scale
Standard Deviation 11.67
|
|
Quality of Life Assessments: EPIC-26 Bowel
48 Months Post Treatment
|
92.52 score on a scale
Standard Deviation 12.89
|
|
Quality of Life Assessments: EPIC-26 Bowel
60 Months Post Treatment
|
92.42 score on a scale
Standard Deviation 12.63
|
|
Quality of Life Assessments: EPIC-26 Bowel
72 Months Post Treatment
|
94.31 score on a scale
Standard Deviation 9.79
|
|
Quality of Life Assessments: EPIC-26 Bowel
84 Months Post Treatment
|
94.29 score on a scale
Standard Deviation 10.08
|
|
Quality of Life Assessments: EPIC-26 Bowel
96 Months Post Treatment
|
93.44 score on a scale
Standard Deviation 9.46
|
|
Quality of Life Assessments: EPIC-26 Bowel
108 Months Post Treatment
|
92.89 score on a scale
Standard Deviation 9.73
|
|
Quality of Life Assessments: EPIC-26 Bowel
120 Months Post Treatment
|
93.77 score on a scale
Standard Deviation 8.93
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
CyberKnife Stereotactic Radiosurgery
n=300 Participants
Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
Quality of Life Assessments: EPIC-26 Sexual
Baseline
|
56.79 score on a scale
Standard Deviation 31.95
|
|
Quality of Life Assessments: EPIC-26 Sexual
1 Month Post Treatment
|
53.74 score on a scale
Standard Deviation 31.47
|
|
Quality of Life Assessments: EPIC-26 Sexual
6 Months Post Treatment
|
53.74 score on a scale
Standard Deviation 33.49
|
|
Quality of Life Assessments: EPIC-26 Sexual
12 Months Post Treatment
|
50.19 score on a scale
Standard Deviation 32.83
|
|
Quality of Life Assessments: EPIC-26 Sexual
24 Months Post Treatment
|
47.71 score on a scale
Standard Deviation 32.27
|
|
Quality of Life Assessments: EPIC-26 Sexual
36 Months Post Treatment
|
47.31 score on a scale
Standard Deviation 32.36
|
|
Quality of Life Assessments: EPIC-26 Sexual
48 Months Post Treatment
|
46.82 score on a scale
Standard Deviation 31.60
|
|
Quality of Life Assessments: EPIC-26 Sexual
60 Months Post Treatment
|
42.88 score on a scale
Standard Deviation 31.45
|
|
Quality of Life Assessments: EPIC-26 Sexual
72 Months Post Treatment
|
47.66 score on a scale
Standard Deviation 33.93
|
|
Quality of Life Assessments: EPIC-26 Sexual
84 Months Post Treatment
|
48.12 score on a scale
Standard Deviation 34.47
|
|
Quality of Life Assessments: EPIC-26 Sexual
96 Months Post Treatment
|
44.16 score on a scale
Standard Deviation 30.34
|
|
Quality of Life Assessments: EPIC-26 Sexual
108 Months Post Treatment
|
43.36 score on a scale
Standard Deviation 31.36
|
|
Quality of Life Assessments: EPIC-26 Sexual
120 Months Post Treatment
|
50.13 score on a scale
Standard Deviation 31.08
|
Adverse Events
CyberKnife Stereotactic Radiosurgery
Serious events: 34 serious events
Other events: 302 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
CyberKnife Stereotactic Radiosurgery
n=310 participants at risk
Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
General disorders
car accident
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Cardiac disorders
Conduction abnormality/ atrioventricular heart block
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Cardiac disorders
Hypertension
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Cardiac disorders
left ventricular diastolic dysfunction
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Cardiac disorders
Valvular heart disease
|
0.65%
2/310 • Number of events 2 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression NOS
|
0.65%
2/310 • Number of events 2 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
General disorders
Death NOS
|
2.9%
9/310 • Number of events 9 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin other - cancer
|
0.65%
2/310 • Number of events 2 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Gastrointestinal disorders
GI - other - cancer
|
0.97%
3/310 • Number of events 3 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Hepatobiliary disorders
Hepatobiliary/pancreas - other - cancer
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Hepatobiliary disorders
Hepatobiliary/pancreas - other cirrhosis
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Infections and infestations
Infection - heart endocarditis
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Infections and infestations
infection with unknown ANC
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Metabolism and nutrition disorders
Potassium serum -low
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue - fracture
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.97%
3/310 • Number of events 3 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Nervous system disorders
Neurology - other
|
0.65%
2/310 • Number of events 2 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Nervous system disorders
Seizure
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Nervous system disorders
Syncope (fainting)
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.65%
2/310 • Number of events 2 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory - cancer
|
0.65%
2/310 • Number of events 2 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Renal and urinary disorders
Urinary obstruction
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Renal and urinary disorders
Renal/GU - other - cancer
|
0.65%
2/310 • Number of events 2 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Renal and urinary disorders
Renal Failure
|
0.65%
2/310 • Number of events 2 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other malignancy
|
0.65%
2/310 • Number of events 4 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.65%
2/310 • Number of events 2 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Vascular disorders
vessel-injury artery - aorta
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Gastrointestinal disorders
GI - other, diverticulosis
|
0.32%
1/310 • Number of events 1 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
Other adverse events
| Measure |
CyberKnife Stereotactic Radiosurgery
n=310 participants at risk
Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
|
|---|---|
|
General disorders
Fatigue
|
36.5%
113/310 • Number of events 120 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Gastrointestinal disorders
Constipation
|
13.9%
43/310 • Number of events 46 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Gastrointestinal disorders
Diarrhea
|
38.7%
120/310 • Number of events 135 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Gastrointestinal disorders
Flatulence
|
9.7%
30/310 • Number of events 31 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.2%
16/310 • Number of events 17 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Gastrointestinal disorders
Proctitis
|
14.2%
44/310 • Number of events 51 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Gastrointestinal disorders
GI Hemorrhage/Bleeding
|
16.8%
52/310 • Number of events 55 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Gastrointestinal disorders
GI Pain
|
8.1%
25/310 • Number of events 25 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Renal and urinary disorders
GU Pain
|
59.4%
184/310 • Number of events 231 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Renal and urinary disorders
Urinary Incontinence
|
9.0%
28/310 • Number of events 38 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Renal and urinary disorders
Urinary Frequency/Urgency
|
74.8%
232/310 • Number of events 332 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Renal and urinary disorders
Urinary Retention
|
50.6%
157/310 • Number of events 190 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.5%
14/310 • Number of events 15 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Renal and urinary disorders
GU Hemorrhage/Bleeding
|
15.8%
49/310 • Number of events 63 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.5%
17/310 • Number of events 19 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Reproductive system and breast disorders
Ejaculatory Dysfunction
|
5.2%
16/310 • Number of events 17 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
21.3%
66/310 • Number of events 66 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Pain
|
7.4%
23/310 • Number of events 25 • Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place