ProSpace™ Balloon System Pivotal Study BP-007

Prostate Cancer Clinical Trial

Official title:

CLINICAL PROTOCOL for the INVESTIGATION Of the ProSpace™ Balloon System Pivotal Study BP-007

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400150
• Other study ID #: BP-007
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: December 10, 2021

Study information

• Verified date: May 2022
• Source: BioProtect
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• ProSpace
ProSpace balloon implantation

Other:
• Control
Control - Marking & IMRT are standard of care for prostate cancer - there is no study-specific intervention

Locations

Country	Name	City	State
Israel	Assuta Ashdod	Ashdod
Israel	Rabin Medical Center	Petah Tikva
Netherlands	Maastro	Maastricht
Poland	Institute of Maria Sklodowska-Oncology Centre	Warsaw
Portugal	CUF Porto Instituto	Porto
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United States	Western Radiation Oncology	Apple Valley	California
United States	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Rush University Cancer Center	Chicago	Illinois
United States	Advanced Urology Institute	Daytona Beach	Florida
United States	KSK Medical Center	Irvine	California
United States	Advanced Radiation Center of New York	Lake Success	New York
United States	New York University Langone Health	New York	New York
United States	Chesapeake Urology Research Associates	Owings Mills	Maryland
United States	Urology Nevada	Reno	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
BioProtect

Countries where clinical trial is conducted

United States,  Israel,  Netherlands,  Poland,  Portugal,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Duration of at least 2 days through 6 months
Primary	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.	6 months

External Links

•   Company website