Prostate Cancer
Conditions
Keywords
Prostate cancer, Spacer
Brief summary
Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)
Detailed description
The purpose of this study is to evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT) and to evaluate whether use of the SpaceOAR hydrogel results in a reduction of radiation exposure to the anterior rectum.
Interventions
DEVICESpaceOAR System
Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.
Sponsors
Augmenix, Inc.
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects greater than 18 years old * Subjects must have pathologically confirmed invasive adenocarcinoma of the prostate and must be planning to undergo IMRT * Subjects must have clinical stage T1 or T2 as determined from a biopsy taken within 6 months of the baseline/screening visit with Gleason Score less than or equal to 7 * Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria: PSA less than or equal to 20 ng/mL,hematocrit greater than 30%,serum creatinine less than 2.0 mg/dl, serum AST and ALT less than 2.5 times upper limit of institution normal, and serum bilirubin less than 2.0 mg/dl * Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site
Exclusion criteria
* Prostate greater than 80cc documented within 3 months preceding the Screening/Baseline visit * Subjects with extracapsular extension of the prostate cancer, with greater than 50% of the number of biopsy cores positive for cancer, metastatic disease, other ongoing cancers which will be treated during the study, or subjects for whom pelvic lymph node radiotherapy is planned * Subjects with any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years. * Subjects who are indicated for androgen deprivation therapy or who have been treated with androgen therapy within the prior 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Achieving a Reduction of 25% or Greater in Percent Volume of the Rectum Receiving at Least 70 Gy Measured From CT Scans Acquired Pre and Post SpaceOAR Hydrogel Injection | 3 months post index procedure | Measurements calculated and documented by the Core Lab. Measurements performed with the Core Lab blinded to subject identification. Results based on the Core Lab computation are considered as primary. |
| Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure | 6 months post index procedure | The primary safety endpoint was the occurrence of Grade 1 or greater rectal adverse events or procedure adverse events in the 6 months following the Index Procedure. The numbers reflect the percent of subjects in each arm/group that experienced grade 1 or greater rectal or procedure adverse events post index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Requiring at Least One Medication Change for Mitigation of Rectal or Urinary Symptoms or for Procedure-related Events in the 6 Months Following the Index Procedure | 6 months post procedure | The numbers reflect the percent of subjects in each arm/group that required at least one medication change to treat rectal or urinary symptoms in the 6 months post index procedure. |
| Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure | 6 months post index procedure | The numbers reflect the percent of subjects in each arm/group that experienced grade 2 or greater rectal or procedure adverse events post index procedure. |
| Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event | 21 days post index procedure | All subjects begin Intensity Modulated Radiation Therapy (IMRT) within 21 days following index procedure (Fiducial Marker Placement with or without SpaceOAR Hydrogel Injection). |
| Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy | 21 days post index procedure, prior to initiation of radiation therapy | An event was classified as a Procedure AE if it occurred during during and immediately after the Index Procedure or was deemed to be associated with the Index Procedure by the Clinical Events Committee (CEC). Per protocol subjects were to begin intensity modulated radiation therapy within 21 days following fiducial marker and/or SpaceOAR placement. |
| Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | 3 months, 6 months, 12 months, 15 months | Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive survey instrument designed to assesses the disease-specific aspects of prostate cancer and its therapies and comprises four domains. Scores for each domain (urinary, sexual, bowel, hormonal) range from 0-100, with higher scores indicating improved quality of life. Scores are reported as mean change from baseline at each time point. |
Countries
United States
Participant flow
Recruitment details
The first subject was treated on January 27, 2012 and the last subject visit occurred on July 15, 2014.
Pre-assignment details
Randomized study, no wash out or run-in period
Participants by arm
| Arm | Count |
|---|---|
| SpaceOAR Subjects randomized to receive SpaceOAR hydrogel. | 149 |
| Control Subjects randomized to not receive SpaceOAR hydrogel. | 73 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | SpaceOAR | Total | Control |
|---|---|---|---|
| Age, Continuous | 66.36 years STANDARD_DEVIATION 7.73 | 66.39 years STANDARD_DEVIATION 7.39 | 67.66 years STANDARD_DEVIATION 6.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 7 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 144 Participants | 215 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 24 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 127 Participants | 188 Participants | 61 Participants |
| Region of Enrollment United States | 149 participants | 222 participants | 73 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 149 Participants | 222 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 149 | 0 / 73 |
| other Total, other adverse events | 17 / 149 | 2 / 73 |
| serious Total, serious adverse events | 21 / 149 | 10 / 73 |
Outcome results
Primary
Number of Subjects Achieving a Reduction of 25% or Greater in Percent Volume of the Rectum Receiving at Least 70 Gy Measured From CT Scans Acquired Pre and Post SpaceOAR Hydrogel Injection
Measurements calculated and documented by the Core Lab. Measurements performed with the Core Lab blinded to subject identification. Results based on the Core Lab computation are considered as primary.
Time frame: 3 months post index procedure
Population: SpaceOAR Group Only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SpaceOAR | Number of Subjects Achieving a Reduction of 25% or Greater in Percent Volume of the Rectum Receiving at Least 70 Gy Measured From CT Scans Acquired Pre and Post SpaceOAR Hydrogel Injection | 143 Participants |
p-value: 0.0001Exact binomial test
Primary
Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure
The primary safety endpoint was the occurrence of Grade 1 or greater rectal adverse events or procedure adverse events in the 6 months following the Index Procedure. The numbers reflect the percent of subjects in each arm/group that experienced grade 1 or greater rectal or procedure adverse events post index procedure.
Time frame: 6 months post index procedure
Population: Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SpaceOAR | Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure | 34.2 percentage of subjects |
| Control | Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure | 31.5 percentage of subjects |
Secondary
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive survey instrument designed to assesses the disease-specific aspects of prostate cancer and its therapies and comprises four domains. Scores for each domain (urinary, sexual, bowel, hormonal) range from 0-100, with higher scores indicating improved quality of life. Scores are reported as mean change from baseline at each time point.
Time frame: 3 months, 6 months, 12 months, 15 months
Population: Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group). Mean change in score was calculated for the number of subjects providing data at each follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Urinary Assessment Composite Score at 3 Months | -11.69 score on a scale | Standard Deviation 13.2 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Urinary Assessment Composite Score at 6 Months | 1.38 score on a scale | Standard Deviation 9.82 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Urinary Assessment Composite Score at 12 Months | 0.12 score on a scale | Standard Deviation 11.74 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Urinary Assessment Composite Score at 15 Months | 1.69 score on a scale | Standard Deviation 11.74 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Sexual Assessment Composite Score at 3 Months | -7.60 score on a scale | Standard Deviation 17.36 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Sexual Assessment Composite Score at 6 Months | -3.44 score on a scale | Standard Deviation 16.74 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Sexual Assessment Composite Score at 12 Months | -7.21 score on a scale | Standard Deviation 19.32 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Sexual Assessment Composite Score at 15 Months | -6.55 score on a scale | Standard Deviation 19.71 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Bowel Habits Assessment Composite Score at 3 Months | -7.47 score on a scale | Standard Deviation 12.69 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Bowel Habits Assessment Composite Score at 6 Months | -0.78 score on a scale | Standard Deviation 8.52 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Bowel Habits Assessment Composite Score at 12 Months | -0.95 score on a scale | Standard Deviation 9.69 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Bowel Habits Assessment Composite Score at 15 Months | -0.02 score on a scale | Standard Deviation 9.41 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Hormonal Assessment Composite Score at 3 Months | -2.69 score on a scale | Standard Deviation 9.96 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Hormonal Assessment Composite Score at 6 Months | -0.71 score on a scale | Standard Deviation 9.05 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Hormonal Assessment Composite Score at 12 Months | -0.71 score on a scale | Standard Deviation 9.45 |
| SpaceOAR | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Hormonal Assessment Composite Score at 15 Months | 0.03 score on a scale | Standard Deviation 9.58 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Hormonal Assessment Composite Score at 15 Months | 0.70 score on a scale | Standard Deviation 8.92 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Urinary Assessment Composite Score at 3 Months | -11.20 score on a scale | Standard Deviation 16.5 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Bowel Habits Assessment Composite Score at 3 Months | -6.24 score on a scale | Standard Deviation 12.05 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Urinary Assessment Composite Score at 6 Months | -0.83 score on a scale | Standard Deviation 13.12 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Hormonal Assessment Composite Score at 3 Months | -3.87 score on a scale | Standard Deviation 8.99 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Urinary Assessment Composite Score at 12 Months | 0.30 score on a scale | Standard Deviation 13.51 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Bowel Habits Assessment Composite Score at 6 Months | -2.44 score on a scale | Standard Deviation 9.54 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Urinary Assessment Composite Score at 15 Months | 2.2 score on a scale | Standard Deviation 11.66 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Hormonal Assessment Composite Score at 12 Months | -0.81 score on a scale | Standard Deviation 8.88 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Sexual Assessment Composite Score at 3 Months | -4.86 score on a scale | Standard Deviation 19.83 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Bowel Habits Assessment Composite Score at 12 Months | -3.08 score on a scale | Standard Deviation 8.61 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Sexual Assessment Composite Score at 6 Months | -2.35 score on a scale | Standard Deviation 18.68 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Hormonal Assessment Composite Score at 6 Months | -2.35 score on a scale | Standard Deviation 11.33 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Sexual Assessment Composite Score at 12 Months | -8.29 score on a scale | Standard Deviation 20.51 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Bowel Habits Assessment Composite Score at 15 Months | -2.14 score on a scale | Standard Deviation 9.29 |
| Control | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure | Change in Sexual Assessment Composite Score at 15 Months | -5.33 score on a scale | Standard Deviation 21.52 |
Secondary
Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy
An event was classified as a Procedure AE if it occurred during during and immediately after the Index Procedure or was deemed to be associated with the Index Procedure by the Clinical Events Committee (CEC). Per protocol subjects were to begin intensity modulated radiation therapy within 21 days following fiducial marker and/or SpaceOAR placement.
Time frame: 21 days post index procedure, prior to initiation of radiation therapy
Population: SpaceOAR treated subjects experiencing a procedure related AE prior to initiation of radiation therapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SpaceOAR | Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy | 14 Participants |
Secondary
Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event
All subjects begin Intensity Modulated Radiation Therapy (IMRT) within 21 days following index procedure (Fiducial Marker Placement with or without SpaceOAR Hydrogel Injection).
Time frame: 21 days post index procedure
Population: Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SpaceOAR | Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event | 0 participants |
| Control | Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event | 0 participants |
Secondary
Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure
The numbers reflect the percent of subjects in each arm/group that experienced grade 2 or greater rectal or procedure adverse events post index procedure.
Time frame: 6 months post index procedure
Population: Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SpaceOAR | Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure | 10 percentage of subjects |
| Control | Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure | 3 percentage of subjects |
Secondary
Percentage of Subjects Requiring at Least One Medication Change for Mitigation of Rectal or Urinary Symptoms or for Procedure-related Events in the 6 Months Following the Index Procedure
The numbers reflect the percent of subjects in each arm/group that required at least one medication change to treat rectal or urinary symptoms in the 6 months post index procedure.
Time frame: 6 months post procedure
Population: Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SpaceOAR | Percentage of Subjects Requiring at Least One Medication Change for Mitigation of Rectal or Urinary Symptoms or for Procedure-related Events in the 6 Months Following the Index Procedure | 56.4 percentage of subjects |
| Control | Percentage of Subjects Requiring at Least One Medication Change for Mitigation of Rectal or Urinary Symptoms or for Procedure-related Events in the 6 Months Following the Index Procedure | 63.9 percentage of subjects |