N/A
N=222
BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03400150 ↗Enrolled (actual)
222
Serious AEs
9.9%
Results posted
Oct 2024
Primary outcome: Primary: 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 — 25; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- balloon (Device); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- BioProtect
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
25; 18 | — |
| PRIMARY Efficacy Endpoint: Number of Subjects in the Balloon Group With Reduction of >25% in Rectal Volume Receiving 70 Gy (rV70) |
139 | 0.025 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT03400150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.