Trial Outcomes & Findings for CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer (NCT NCT01985828)
NCT ID: NCT01985828
Last Updated: 2024-10-03
Results Overview
Phoenix definition: Biochemical recurrence of prostate cancer (PCa) after curative radiotherapy defined as a prostate-specific antigen (PSA) rise of ≥2 ng/ml above the nadir. Astro definition: Biochemical failure in prostate cancer defined as three consecutive rises in prostate-specific antigen (PSA) after a nadir.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
3 years
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
Intermediate Risk
Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy
OR
Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5)
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT): Per current standard of care
|
High Risk
Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT): Per current standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
30
|
|
Overall Study
COMPLETED
|
47
|
29
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intermediate Risk
n=53 Participants
Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy
OR
Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5)
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT): Per current standard of care
|
High Risk
n=30 Participants
Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT): Per current standard of care
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=53 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=83 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=53 Participants
|
11 Participants
n=30 Participants
|
25 Participants
n=83 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=53 Participants
|
19 Participants
n=30 Participants
|
58 Participants
n=83 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=53 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=53 Participants
|
30 Participants
n=30 Participants
|
83 Participants
n=83 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
53 Participants
n=53 Participants
|
30 Participants
n=30 Participants
|
83 Participants
n=83 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPhoenix definition: Biochemical recurrence of prostate cancer (PCa) after curative radiotherapy defined as a prostate-specific antigen (PSA) rise of ≥2 ng/ml above the nadir. Astro definition: Biochemical failure in prostate cancer defined as three consecutive rises in prostate-specific antigen (PSA) after a nadir.
Outcome measures
| Measure |
Intermediate Risk
n=47 Participants
Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy
OR
Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5)
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT): Per current standard of care
|
High Risk
n=29 Participants
Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT): Per current standard of care
|
|---|---|---|
|
Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions
Phoenix Definition
|
46 Participants
|
27 Participants
|
|
Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions
Astro Definition
|
45 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 3 yearsAcute toxicity is graded based upon Common Terminology Criteria for Adverse Events (CTCAE). The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is a standardized system used to classify and grade the severity of adverse events (AEs) experienced by cancer patients during treatment, with a grading scale ranging from 1 (mild) to 5 (death).
Outcome measures
| Measure |
Intermediate Risk
n=47 Participants
Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy
OR
Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5)
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT): Per current standard of care
|
High Risk
n=29 Participants
Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT): Per current standard of care
|
|---|---|---|
|
Measure the Rates of Acute and Late Grade 3-5 Gastrointestinal and Genitourinary Toxicity
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 yearsThe 26-item version of EPIC, also known as EPIC Short Form or EPIC-26, contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best).
Outcome measures
| Measure |
Intermediate Risk
n=47 Participants
Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy
OR
Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5)
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT): Per current standard of care
|
High Risk
n=29 Participants
Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT): Per current standard of care
|
|---|---|---|
|
Expanded Prostate Cancer Index Composite Epic-26
|
78.73 units on a scale
Interval 37.88 to 95.6
|
78.73 units on a scale
Interval 37.88 to 95.6
|
Adverse Events
Intermediate Risk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Risk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place