ProSpace Balloon System Pivotal Study BP-007

  • End date
    May 31, 2021
  • participants needed
  • sponsor
Updated on 30 July 2020
adenocarcinoma of prostate


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.


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).

Treatment Control, ProSpace
Clinical Study IdentifierNCT03400150
Last Modified on30 July 2020

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: Prostate Cancer or Prostate Disorders or Prostatic disorder or Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate?
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
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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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