Back to resultsProSpace™ Balloon System Pivotal Study BP-007
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ProSpace
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Western Radiation Oncology
- KSK Medical Center
- Advanced Urology Institute
- Rush University Cancer Center
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
- Chesapeake Urology Research Associates
- Urology Nevada
- Advanced Radiation Center of New York
- New York University Langone Health
- Medical University of South Carolina (MUSC)
- Assuta Ashdod
- Rabin Medical Center
- Maastro
- Institute of Maria Skłodowska-Oncology Centre
- CUF Porto Instituto
- Beatson West of Scotland Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
ProSpace group
Control group
Arm Description
Marking + ProSpace implantation + IMRT
Marking + IMRT
Outcomes
Primary Outcome Measures
Adverse Event Rate of Occurrence
Rate of occurrence of Grade 1 or greater rectal adverse events and implantation procedure related adverse events through 6 months.
Reduction in Rectal Radiation Exposure
Reduction of at least 25% of the volume of the rectum receiving greater or equal to 70 Gy (VRectum70) when compared to pre-implantation values.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03400150
Brief Title
ProSpace™ Balloon System Pivotal Study BP-007
Official Title
CLINICAL PROTOCOL for the INVESTIGATION Of the ProSpace™ Balloon System Pivotal Study BP-007
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioProtect
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The ProSpace™ 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 ProSpace System to reduce the radiation dose delivered to the anterior rectum. ProSpace is a 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 ProSpace Balloon in prostate cancer subjects undergoing radiotherapy by means of intensity modulation radiation therapy (IMRT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized in a 2:1 ratio (ProSpace implantation:control)
Masking
Participant
Masking Description
Study subjects are blinded to group assignment.
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProSpace group
Arm Type
Experimental
Arm Description
Marking + ProSpace implantation + IMRT
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Marking + IMRT
Intervention Type
Device
Intervention Name(s)
ProSpace
Intervention Description
ProSpace balloon implantation
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Control - Marking & IMRT are standard of care for prostate cancer - there is no study-specific intervention
Primary Outcome Measure Information:
Title
Adverse Event Rate of Occurrence
Description
Rate of occurrence of Grade 1 or greater rectal adverse events and implantation procedure related adverse events through 6 months.
Time Frame
Duration of at least 2 days through 6 months
Title
Reduction in Rectal Radiation Exposure
Description
Reduction of at least 25% of the volume of the rectum receiving greater or equal to 70 Gy (VRectum70) when compared to pre-implantation values.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Western Radiation Oncology
City
Apple Valley
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
KSK Medical Center
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Advanced Urology Institute
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Rush University Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Urology Nevada
City
Reno
State/Province
Nevada
ZIP/Postal Code
89521
Country
United States
Facility Name
Advanced Radiation Center of New York
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
New York University Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Assuta Ashdod
City
Ashdod
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
Country
Israel
Facility Name
Maastro
City
Maastricht
Country
Netherlands
Facility Name
Institute of Maria Skłodowska-Oncology Centre
City
Warsaw
Country
Poland
Facility Name
CUF Porto Instituto
City
Porto
Country
Portugal
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.bioprotect.com
Description
Company website
Learn more about this trial
ProSpace™ Balloon System Pivotal Study BP-007
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