ProSpace™ Balloon System Pivotal Study BP-007
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2018 |
| Start Date: | January 3, 2018 |
| End Date: | July 31, 2019 |
| Contact: | Joyce Dunsmore |
| Email: | joyce@bioprotect.com |
| Phone: | 703-628-8603 |
CLINICAL PROTOCOL for the INVESTIGATION Of the ProSpace™ Balloon System Pivotal Study BP-007
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.
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.
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).
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).
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 6 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
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