Prostate Cancer
Conditions
Brief summary
The BioProtect Balloon Implant™ System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the balloon to reduce the radiation dose delivered to the anterior rectum. The balloon composed of a biodegradable material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
Detailed description
This study will be a prospective, multi-center, randomized, double-arm, single blind, concurrently controlled study to assess the safety and efficacy of the balloon in prostate cancer subjects undergoing radiotherapy by means of intensity modulation radiation therapy (IMRT).
Interventions
DEVICEballoon
balloon implantation
OTHERControl
Control - Marking & IMRT are standard of care for prostate cancer - there is no study-specific intervention
Sponsors
BioProtect
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Study subjects are blinded to group assignment.
Intervention model description
Subjects will be randomized in a 2:1 ratio (balloon implantation:control)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age * Have been histologically diagnosed with invasive adenocarcinoma of the prostate, at clinical stage T1-T3 (as determined by a biopsy taken within 9 months of the screening visit) * Be scheduled for radiation therapy (XRT) by means of IMRT
Exclusion criteria
* Any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years * Prior radical prostatectomy * Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer * Prior radiotherapy to the pelvis, including brachytherapy * History of prior surgery involving the rectum or anus * Prior surgical procedure involving the peri-rectal and/or peri-prostatic area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint: Number of Subjects in the Balloon and Control Groups With Rectal, Device or Procedure-related Grade > 1 AEs Within 6 Months of Procedure | Within 6 months from balloon implantation | Non-inferiority in occurrence of rectal, device or procedure-related Grade \> 1 AEs within 6 months of implantation for balloon as compared to control group |
| Efficacy Endpoint: Number of Subjects in the Balloon Group With Reduction of >25% in Rectal Volume Receiving 70 Gy (rV70) | 3 months | Observed reduction of at least \>25% in rectal volume receiving 70 Gy (rV70) in patients after spacer implantation, with efficacy of the study confirmed if \>75% of balloon recipients achieved this degree of dose reduction. |
Countries
Israel, Netherlands, Poland, Portugal, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balloon Group Marking + Balloon implantation + IMRT
Balloon implantation | 143 |
| Control Group Marking + IMRT
Control: Control - Marking & IMRT are standard of care for prostate cancer - there is no study-specific intervention | 79 |
| Total | 222 |
Baseline characteristics
| Characteristic | Balloon Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 70.2 years STANDARD_DEVIATION 6.29 | 70.5 years STANDARD_DEVIATION 6.61 | 71.1 years STANDARD_DEVIATION 7.16 |
| Localized prostate cancer | 143 Participants | 222 Participants | 79 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 19 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) White | 120 Participants | 185 Participants | 65 Participants |
| Region of Enrollment Ireland | 5 participants | 7 participants | 2 participants |
| Region of Enrollment Israel | 23 participants | 38 participants | 15 participants |
| Region of Enrollment Netherlands | 13 participants | 20 participants | 7 participants |
| Region of Enrollment Poland | 26 participants | 39 participants | 13 participants |
| Region of Enrollment Portugal | 18 participants | 27 participants | 9 participants |
| Region of Enrollment United Kingdom | 3 participants | 4 participants | 1 participants |
| Region of Enrollment United States | 55 participants | 87 participants | 32 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 143 Participants | 222 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 143 | 0 / 79 |
| other Total, other adverse events | 108 / 143 | 60 / 79 |
| serious Total, serious adverse events | 12 / 143 | 10 / 79 |
Outcome results
Primary
Efficacy Endpoint: Number of Subjects in the Balloon Group With Reduction of >25% in Rectal Volume Receiving 70 Gy (rV70)
Observed reduction of at least \>25% in rectal volume receiving 70 Gy (rV70) in patients after spacer implantation, with efficacy of the study confirmed if \>75% of balloon recipients achieved this degree of dose reduction.
Time frame: 3 months
Population: The balloon spacer implantation was attempted in 143 subjects. The procedure could not be completed for one subject, resulting in an efficacy endpoint population of 142 balloon subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Balloon Group | Efficacy Endpoint: Number of Subjects in the Balloon Group With Reduction of >25% in Rectal Volume Receiving 70 Gy (rV70) | 139 Participants |
p-value: 0.025Farrington-Manning
Primary
Safety Endpoint: Number of Subjects in the Balloon and Control Groups With Rectal, Device or Procedure-related Grade > 1 AEs Within 6 Months of Procedure
Non-inferiority in occurrence of rectal, device or procedure-related Grade \> 1 AEs within 6 months of implantation for balloon as compared to control group
Time frame: Within 6 months from balloon implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Balloon Group | Safety Endpoint: Number of Subjects in the Balloon and Control Groups With Rectal, Device or Procedure-related Grade > 1 AEs Within 6 Months of Procedure | 25 Participants |
| Control Group | Safety Endpoint: Number of Subjects in the Balloon and Control Groups With Rectal, Device or Procedure-related Grade > 1 AEs Within 6 Months of Procedure | 18 Participants |