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ProSpace™ Balloon System Pivotal Study BP-007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400150
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
BioProtect

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: ProSpace Other: Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized in a 2:1 ratio (ProSpace implantation:control)
Masking: Single (Participant)
Masking Description: Study subjects are blinded to group assignment.
Primary Purpose: Supportive Care
Official Title: CLINICAL PROTOCOL for the INVESTIGATION Of the ProSpace™ Balloon System Pivotal Study BP-007
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : December 10, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: ProSpace group
Marking + ProSpace implantation + IMRT
 Device: ProSpace
ProSpace balloon implantation
Sham Comparator: Control group
Marking + IMRT
 Other: Control
Control - Marking & IMRT are standard of care for prostate cancer - there is no study-specific intervention


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Event Rate of Occurrence [ Time Frame: Duration of at least 2 days through 6 months ]
    Rate of occurrence of Grade 1 or greater rectal adverse events and implantation procedure related adverse events through 6 months.

  2. Reduction in Rectal Radiation Exposure [ Time Frame: 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400150


Locations
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United States, California
Western Radiation Oncology
Apple Valley, California, United States, 95008
KSK Medical Center
Irvine, California, United States, 92618
United States, Florida
Advanced Urology Institute
Daytona Beach, Florida, United States, 32114
United States, Illinois
Rush University Cancer Center
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Chesapeake Urology Research Associates
Owings Mills, Maryland, United States, 21117
United States, Nevada
Urology Nevada
Reno, Nevada, United States, 89521
United States, New York
Advanced Radiation Center of New York
Lake Success, New York, United States, 11042
New York University Langone Health
New York, New York, United States, 10016
United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Israel
Assuta Ashdod
Ashdod, Israel
Rabin Medical Center
Petah Tikva, Israel
Netherlands
Maastro
Maastricht, Netherlands
Poland
Institute of Maria Skłodowska-Oncology Centre
Warsaw, Poland
Portugal
CUF Porto Instituto
Porto, Portugal
United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Sponsors and Collaborators
BioProtect
More Information
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Additional Information:

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Responsible Party: BioProtect
ClinicalTrials.gov Identifier: NCT03400150    
Other Study ID Numbers: BP-007
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases