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Trial record 1 of 1 for:    BP-007
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400150
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
BioProtect

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).

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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 : March 30, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




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.



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Joyce Dunsmore 703-628-8603 joyce@bioprotect.com

Locations
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United States, California
Western Radiation Oncology Recruiting
Apple Valley, California, United States, 95008
Contact: Jennifer Woltz    650-485-9904    woltzjn@gmail.com   
KSK Medical Center Recruiting
Irvine, California, United States, 92618
Contact: Kenneth Tokita, MD    949-417-1100    LBarnes@ccoi.org   
United States, Florida
Advanced Urology Institute Recruiting
Daytona Beach, Florida, United States, 32114
Contact: Jonelle Morsley    386-239-8535    jonelle.horsley@auihealth.com   
United States, Illinois
Rush University Cancer Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Estefania Gonzalez Arreaza       Estefania_GonzalezArreaza@rush.edu   
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Hamza Hasan    410-955-8652    hhasan2@jhmi.edu   
Chesapeake Urology Research Associates Recruiting
Owings Mills, Maryland, United States, 21117
Contact: Richard Hudes, MD    443-231-1203    rbennett@chesuro.com   
United States, Nevada
Urology Nevada Recruiting
Reno, Nevada, United States, 89521
Contact: Michael Kos, MD    775-850-6505    amoliga@urologynevada.com   
United States, New York
Advanced Radiation Center of New York Recruiting
Lake Success, New York, United States, 11042
Contact: Jessica Blanco    516-394-9600    jblanco@imppllc.com   
New York University Langone Health Recruiting
New York, New York, United States, 10016
Contact: Ashley Brown       Ashley.Brown4@nyulangone.org   
United States, South Carolina
Medical University of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States, 29425
Contact: Alan Brisendine    843-792-9007    brisend@musc.edu   
Israel
Assuta Ashdod Recruiting
Ashdod, Israel
Contact: Yewgeniya Vitkin    972-72-3398279    yewgeniyavi@assuta.co.il   
Rabin Medical Center Recruiting
Petah Tikva, Israel
Contact: Yarra Barr       yaaraba1@clalit.org.il   
Netherlands
Maastro Recruiting
Maastricht, Netherlands
Contact: Evelin van der Peet    31884455874    Evelien.vanderPeet@maastro.nl   
Poland
Institute of Maria Skłodowska-Oncology Centre Recruiting
Warsaw, Poland
Contact: Pitor Saniewski       p.saniewski@gmail.com   
Portugal
CUF Porto Instituto Recruiting
Porto, Portugal
Contact: Paulo Costa    +351-22 00 34 001    Luis.Rosa@jmellosaude.pt   
United Kingdom
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom
Contact: Elaine MacLeod       Elaine.MacLeod2@ggc.scot.nhs.uk   
Sponsors and Collaborators
BioProtect
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: January 14, 2021
Last Verified: July 2020
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