Trial Outcomes & Findings for Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery (NCT NCT02830165)
NCT ID: NCT02830165
Last Updated: 2024-05-23
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
At 4 weeks post surgery
Results posted on
2024-05-23
Participant Flow
The study was open to recruitment from 6/15/2016 and closed to enrollment 09/08/2019
Participant milestones
| Measure |
Stereotactic Body Radiation Therapy (SBRT)
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
Baseline characteristics by cohort
| Measure |
Stereotactic Body Radiation Therapy (SBRT)
n=11 Participants
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
|
Gleason Grade
Gleason 9
|
3 Participants
n=93 Participants
|
|
Gleason Grade
Gleason 8
|
5 Participants
n=93 Participants
|
|
Gleason Grade
Gleason 7
|
3 Participants
n=93 Participants
|
|
CStage
cT1cNoMo
|
2 Participants
n=93 Participants
|
|
CStage
cT1cN1Mo
|
1 Participants
n=93 Participants
|
|
CStage
cT2aNoMo
|
2 Participants
n=93 Participants
|
|
CStage
cT2bNoMo
|
2 Participants
n=93 Participants
|
|
CStage
cT2cN1Mo
|
1 Participants
n=93 Participants
|
|
CStage
cT3aNoMo
|
1 Participants
n=93 Participants
|
|
CStage
cT3aN1Mo
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: At 4 weeks post surgeryOutcome measures
| Measure |
Treatment Stereotactic Body Radiotherapy (SBRT)
n=11 Participants
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
Post SBRT and Radical Prostatectomy (RP)
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
|---|---|---|
|
Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearBased on the Common Terminology Criteria for Adverse Events (CTCAE) v4. Grade refers to the severity of the adverse event. Indications are Grade 1 is Mild, Grade 2 is Moderate, Grade 3 is Severe or medically significant but not immediately life threatening. Grade 0 refers to absence of an adverse event (ae).
Outcome measures
| Measure |
Treatment Stereotactic Body Radiotherapy (SBRT)
n=11 Participants
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
Post SBRT and Radical Prostatectomy (RP)
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
|---|---|---|
|
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Genitourinary Toxicities · Grade 0
|
1 Participants
|
—
|
|
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Genitourinary Toxicities · Grade 1
|
4 Participants
|
—
|
|
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Genitourinary Toxicities · Grade 2
|
4 Participants
|
—
|
|
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Genitourinary Toxicities · Grade 3
|
2 Participants
|
—
|
|
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Gastrointestinal toxicities · Grade 0
|
9 Participants
|
—
|
|
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Gastrointestinal toxicities · Grade 1
|
1 Participants
|
—
|
|
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Gastrointestinal toxicities · Grade 2
|
1 Participants
|
—
|
|
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Gastrointestinal toxicities · Grade 3
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: score from baseline to twelve monthsPopulation: Mean change in EPIC-26 score from baseline to 12 months. Three patients dd not complete the QOL assessment and therefore were not included in the analysis.
The Expanded Prostate Cancer Index Composite Short Form (EPIC-26) is composed of 26 items and measures health-related quality of life across 5 prostate cancer domains. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing a better quality of life.
Outcome measures
| Measure |
Treatment Stereotactic Body Radiotherapy (SBRT)
n=8 Participants
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
Post SBRT and Radical Prostatectomy (RP)
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
|---|---|---|
|
Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.
Urinary Incontinence
|
-32.8 score on a scale
Interval -55.3 to -10.3
|
—
|
|
Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.
urinary irritative/obstructive
|
-1.6 score on a scale
Interval -9.6 to 6.4
|
—
|
|
Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.
Bowel
|
-2.1 score on a scale
Interval -8.2 to 4.0
|
—
|
|
Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.
Sexual Function
|
-34.4 score on a scale
Interval -49.4 to -19.4
|
—
|
|
Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.
Hormonal
|
-10.6 score on a scale
Interval -26.0 to 4.8
|
—
|
SECONDARY outcome
Timeframe: Mean change in I-PSS score from baseline to 12 months.Population: Three patients dd not complete the QOL assessment and therefore were not included in the analysis.
The International Prostate Symptom Score is composed of seven questions and scored from 0 - 35, with higher scores indicating more severe symptoms.
Outcome measures
| Measure |
Treatment Stereotactic Body Radiotherapy (SBRT)
n=8 Participants
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
Post SBRT and Radical Prostatectomy (RP)
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
|---|---|---|
|
Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.
|
0.5 change in score on a scale
Interval -2.1 to 3.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and to up to 1 yearPopulation: Pre-treatment biopsies and surgical specimens from this trial were used to determine radiation-induced changes in macrophage subsets. Six participants had available paired biopsy cores and Radical Prostatectomy (RP) specimens for analysis.
Tissue specimens of the primary tumor as well as blood draws before and after treatment will be used to conduct biomarker and molecular analyses relevant to understanding the biology of prostate SBRT
Outcome measures
| Measure |
Treatment Stereotactic Body Radiotherapy (SBRT)
n=6 Participants
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
Post SBRT and Radical Prostatectomy (RP)
n=6 Participants
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
|---|---|---|
|
Correlative Biomarker Analyses Using Tissue and Serial Blood Samples
CD11b
|
0.002 Macropahge cells per pixel area
Standard Deviation .07
|
0.004 Macropahge cells per pixel area
Standard Deviation .01
|
|
Correlative Biomarker Analyses Using Tissue and Serial Blood Samples
CD68
|
0.01 Macropahge cells per pixel area
Standard Deviation .05
|
0.035 Macropahge cells per pixel area
Standard Deviation .01
|
|
Correlative Biomarker Analyses Using Tissue and Serial Blood Samples
CD163
|
0.005 Macropahge cells per pixel area
Standard Deviation .05
|
0.03 Macropahge cells per pixel area
Standard Deviation .07
|
SECONDARY outcome
Timeframe: Baseline and to up to 1 yearPopulation: Pre-treatment biopsies and surgical specimens from this trial were used to determine radiation-induced changes in T cell. Six participants had available paired biopsy cores and RP specimens for analysis.
Tissue specimens of the primary tumor as well as blood draws before and after treatment will be used to conduct biomarker and molecular analyses relevant to understanding the biology of prostate SBRT
Outcome measures
| Measure |
Treatment Stereotactic Body Radiotherapy (SBRT)
n=6 Participants
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
Post SBRT and Radical Prostatectomy (RP)
n=6 Participants
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
|---|---|---|
|
Correlative Biomarker Analyses Using Tissue and Serial Blood Samples
CD3+CD8
|
70 cells per Tumor area mm2
Standard Deviation 15
|
30 cells per Tumor area mm2
Standard Deviation 10
|
|
Correlative Biomarker Analyses Using Tissue and Serial Blood Samples
CD3+CD4
|
110 cells per Tumor area mm2
Standard Deviation 10
|
90 cells per Tumor area mm2
Standard Deviation 20
|
|
Correlative Biomarker Analyses Using Tissue and Serial Blood Samples
CD4+FOXp3
|
30 cells per Tumor area mm2
Standard Deviation 10
|
50 cells per Tumor area mm2
Standard Deviation 15
|
Adverse Events
Stereotactic Body Radiation Therapy (SBRT)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stereotactic Body Radiation Therapy (SBRT)
n=11 participants at risk
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Renal and urinary disorders
Urinary Tract Infection
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
Other adverse events
| Measure |
Stereotactic Body Radiation Therapy (SBRT)
n=11 participants at risk
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
2/11 • Number of events 2 • 90 day intervals for 1 year
|
|
Renal and urinary disorders
Difficulty Urinating
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Renal and urinary disorders
Dysuria
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Erectile Dysfunction
|
36.4%
4/11 • Number of events 4 • 90 day intervals for 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
18.2%
2/11 • Number of events 2 • 90 day intervals for 1 year
|
|
Renal and urinary disorders
Incontinence
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Gastrointestinal disorders
Increased Bowel Movement
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Gastrointestinal disorders
Loose Bowel Movement
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Gastrointestinal disorders
Loose Stools
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Loss of Sexual Function
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Mild Pain
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Renal and urinary disorders
Nocturia
|
27.3%
3/11 • Number of events 3 • 90 day intervals for 1 year
|
|
General disorders
Painless Hematuria
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Radiation Colopathy and Proctopathy
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Rectal Bleeding
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Slight Burning when Urinating
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
63.6%
7/11 • Number of events 7 • 90 day intervals for 1 year
|
|
Renal and urinary disorders
Urinary Incontinence
|
54.5%
6/11 • Number of events 8 • 90 day intervals for 1 year
|
|
Renal and urinary disorders
Urinary Tract Pain
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Renal and urinary disorders
Urinary Urgency
|
27.3%
3/11 • Number of events 3 • 90 day intervals for 1 year
|
|
General disorders
Abdominal Pain
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Anxiety
|
18.2%
2/11 • Number of events 2 • 90 day intervals for 1 year
|
|
General disorders
Atrial Fibrillation
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Benign Polyp
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Eye disorders
Bilateral Eye Irritation and Redness
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Chills
|
18.2%
2/11 • Number of events 2 • 90 day intervals for 1 year
|
|
General disorders
Dyspenea
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Edema Suprepubic
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Fatigue
|
45.5%
5/11 • Number of events 5 • 90 day intervals for 1 year
|
|
General disorders
Hot Flashes
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Musculoskeletal and connective tissue disorders
Lower Back Pain
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Middle Mediastinal Schwannoma
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches (neck and shoulders)
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Nausea
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Pain
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Perineal Numbness
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Musculoskeletal and connective tissue disorders
Pseudogout
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
General disorders
Sweating
|
9.1%
1/11 • Number of events 1 • 90 day intervals for 1 year
|
|
Renal and urinary disorders
Urinary Tract Infection
|
18.2%
2/11 • Number of events 2 • 90 day intervals for 1 year
|
Additional Information
Nicholas Nickols, MD
University of California at Los Angeles, David Geffin School of Medicine, Radiation Oncology
Phone: 310 825-8278
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place