- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03400150
ProSpace™ Balloon System Pivotal Study BP-007
May 11, 2022 updated by: BioProtect
CLINICAL PROTOCOL for the INVESTIGATION Of the ProSpace™ Balloon System Pivotal Study BP-007
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
222
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ashdod, Israel
- Assuta Ashdod
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Petah Tikva, Israel
- Rabin Medical Center
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-
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Maastricht, Netherlands
- Maastro
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-
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Warsaw, Poland
- Institute of Maria Skłodowska-Oncology Centre
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-
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Porto, Portugal
- CUF Porto Instituto
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Glasgow, United Kingdom
- Beatson West of Scotland Cancer Centre
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California
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Apple Valley, California, United States, 95008
- Western Radiation Oncology
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Irvine, California, United States, 92618
- KSK Medical Center
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Florida
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Daytona Beach, Florida, United States, 32114
- Advanced Urology Institute
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Cancer Center
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
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Owings Mills, Maryland, United States, 21117
- Chesapeake Urology Research Associates
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Nevada
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Reno, Nevada, United States, 89521
- Urology Nevada
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New York
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Lake Success, New York, United States, 11042
- Advanced Radiation Center of New York
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New York, New York, United States, 10016
- New York University Langone Health
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina (MUSC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ProSpace group
Marking + ProSpace implantation + IMRT
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ProSpace balloon implantation
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Sham Comparator: Control group
Marking + IMRT
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Control - Marking & IMRT are standard of care for prostate cancer - there is no study-specific intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Event Rate of Occurrence
Time Frame: Duration of at least 2 days through 6 months
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Rate of occurrence of Grade 1 or greater rectal adverse events and implantation procedure related adverse events through 6 months.
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Duration of at least 2 days through 6 months
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Reduction in Rectal Radiation Exposure
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2018
Primary Completion (Actual)
December 10, 2021
Study Completion (Actual)
December 10, 2021
Study Registration Dates
First Submitted
January 8, 2018
First Submitted That Met QC Criteria
January 12, 2018
First Posted (Actual)
January 17, 2018
Study Record Updates
Last Update Posted (Actual)
May 12, 2022
Last Update Submitted That Met QC Criteria
May 11, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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