Clinical trial NCT03400150: BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
Official title: CLINICAL PROTOCOL for the INVESTIGATION Of the BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: BioProtect
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 222
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized in a 2:1 ratio (balloon implantation:control)
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: 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
timeFrame: Within 6 months from balloon implantation
measure: Efficacy Endpoint: Number of Subjects in the Balloon Group With Reduction of >25% in Rectal Volume Receiving 70 Gy (rV70)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Apple Valley
country: United States
facility: Western Radiation Oncology
state: California
city: Irvine
country: United States
facility: KSK Medical Center
state: California
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Chicago
country: United States
facility: Rush University Cancer Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Owings Mills
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Reno
country: United States
facility: Urology Nevada
state: Nevada
city: Lake Success
country: United States
facility: Advanced Radiation Center of New York
state: New York
city: New York
country: United States
facility: New York University Langone Health
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Ashdod
country: Israel
facility: Assuta Ashdod
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Maastricht
country: Netherlands
facility: Maastro
city: Warsaw
country: Poland
facility: Institute of Maria Skłodowska-Oncology Centre
city: Porto
country: Portugal
facility: CUF Porto Instituto
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
Study officials:
References: