Trial Outcomes & Findings for Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects (NCT NCT00918229)

Results Overview

Evaluated in subjects with prostate cancer who underwent radiotherapy by means of IMRT and who received the ProSpace, with individual patient success defined as a 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

6 months

Results posted on

2018-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Balloon Implantation One arm study only implantation of an absorbable perirectal spacer balloon balloon implant: Absorbable perirectal spacer implantation Balloon implantation: Implantation of the balloon between the prostate and the anterior rectal wall
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Implantation n=24 Participants implantation of an absorbable perirectal spacer balloon balloon implant: Absorbable perirectal spacer implantation Balloon implantation: Implantation of the balloon between the prostate and the anterior rectal wall
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Evaluated in subjects with prostate cancer who underwent radiotherapy by means of IMRT and who received the ProSpace, with individual patient success defined as a 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.

Outcome measures

Outcome measures
Measure	Balloon Implantation n=24 Participants implantation of an absorbable perirectal spacer balloon balloon implant: Absorbable perirectal spacer implantation Balloon implantation: Implantation of the balloon between the prostate and the anterior rectal wall
Proportion of Subjects Achieving a Reduction of at Least 25% of the Volume of the Rectum Receiving at Least 70 Gy.	24 Participants

SECONDARY outcome

Timeframe: 6 months

Compare the rate of occurrence of rectal adverse events and implantation procedure related adverse events in balloon and control groups.

Outcome measures

Outcome measures
Measure	Balloon Implantation n=24 Participants implantation of an absorbable perirectal spacer balloon balloon implant: Absorbable perirectal spacer implantation Balloon implantation: Implantation of the balloon between the prostate and the anterior rectal wall
Rate of Occurrence of Grade 2 or Greater Rectal Adverse Event or Procedure Related Adverse Events.	0 Participants

Adverse Events

Balloon Implantation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Balloon Implantation n=24 participants at risk implantation of an absorbable perirectal spacer balloon balloon implant: Absorbable perirectal spacer implantation Balloon implantation: Implantation of the balloon between the prostate and the anterior rectal wall
Renal and urinary disorders Bleeding	4.2% 1/24 • Number of events 1 • 6 months The definition used did not differ from the clintrials.gov definition. All data was reviewed for the occurrence of these events. No serious events occurred.
Renal and urinary disorders Urinary retention	4.2% 1/24 • Number of events 1 • 6 months The definition used did not differ from the clintrials.gov definition. All data was reviewed for the occurrence of these events. No serious events occurred.

Additional Information

Shaul Shohat

BioProtect

Phone: +972545423774

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place