Prostate CancerNCT00918229
Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects
A study testing balloon implant and Balloon implantation in people with Prostate Cancer, run by BioProtect at 1 site in United States.
Trial summary
Primary Goal The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine radiation therapy (XRT) treatment. Safety of the BioProtect device will be assessed by reporting adverse events. Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- balloon implant and Balloon implantation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male above 45 years old and less than 85.
- Diagnosed locally confined prostate cancer per hospital practice and definitions for local confined prostate cancer.
- Subject is scheduled for only localized prostate XRT treatments
- Zubrod performance status 0-1; or Karnofsy >80
- Blood CBC and biochemistry up to two weeks before screening demonstrating:
- Platelets ≥ 100,000 cells/mm3
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- Hemoglobin ≥ 10.0 g/dl
- Normal values of electrolytes (sodium, potassium, calcium)
- Normal values of the PT, PTT and INR tests.
- Peak Uroflow rate ≥ 13ml/sec
- Residual Urine volume Test result < 150 ml
- Urinalysis (RBC, WBC) and urine culture
- Subject able to comprehend and give informed consent for participation in this study and are considered by the investigator to have good compliance for the study.
Who cannot join
- Any prior prostate resection with a compliant prostate urethra as assessed by transrectal ultrasound (TRUS)
- Prior radical prostatectomy
- Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer
- Suspected extension of the prostate tumour toward the rectum as evidenced by acceptable imaging modalities used in the study site
- Prior surgical procedure involving peri-rectal and peri-prostatic area
- Prior radiotherapy to the pelvis, including brachytherapy at the same body organ
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- Unstable angina
- Congestive heart failure (CHF) phase III or IV or CHF requiring hospitalization within the last 6 months prior to screening
- Transmural myocardial (MI) infarction within the last 6 months prior to screening
- Moderate to severe respiratory failure, hepatic failure or renal failure
- Acute infection requiring intravenous antibiotics at the time of screening
- Uncontrolled bleeding disorders
- Uncontrolled diabetes mellitus
- Known to be HIV positive or have any other immunosuppressive disorder
- Inflammatory diseases of the perineal skin
- Urinary tract infection or acute or chronic prostatitis
- Uncontrolled moderate to severe urinary disorders
- Active inflammatory bowel disease or moderate to severe gastrointestinal (GI) disorders
- Known or suspected rectal carcinoma
- Subjects after anterior resection of rectum or after rectal amputation
- Concurrent participation in any other clinical study
- Intra-operative exclusion criteria:
- Irregular findings by the implanting physician before or during implantation that to the best of the implanting physician may lead to prostate compliance leading to urinary retention or other such symptoms.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University School of Medicine, Massey Cancer Center
Richmond, Virginia, 23298-0058
About this study
Official title: One-arm, Multi-center, International Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
Primary Goal
The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine radiation therapy (XRT) treatment. Safety of the BioProtect device will be assessed by reporting adverse events.
Secondary Goal
The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum.
Read the detailed description
Primary Endpoint Parameters
The incidence of unexpected serious adverse events related to BioProtect's SpaceGuard balloon implant and/or implantation procedure:
- Serious Adverse Events related to the BioProtect balloon and/or implantation procedure were defined by the Clinical Trials.gov definition of a serious adverse event. Serious Adverse Events will be documented in Serious Adverse Event Form.
- Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events were documented in Adverse Event Form.
- Subjective discomfort related to the balloon and implantation procedure were assessed by a pain analogue scale.
Secondary Endpoint Parameters A 10% decrease or greater of the average rectal doses at V50 in at least 75% of the subjects after balloon implantation as compared to the doses at V50 before the balloon implantation. This was measured by routine Dose Volume Histogram (DVH) per local hospital practice and according to the instructions regarding anatomical landmarks delineated in this protocol.
- Conditions
- Prostate Cancer
- Being tested
- balloon implant, Balloon implantation
- Keywords
- Prostate, cancer, radiation, biodegradable implantable balloon, intrarectal balloon
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon implantDevice
Absorbable perirectal spacer implantation
Balloon implantationProcedure or surgery
Implantation of the balloon between the prostate and the anterior rectal wall
| Study group | Role | What they receive |
|---|---|---|
| balloon implantation | Other | implantation of an absorbable perirectal spacer balloon Receives: Device: balloon implant; Procedure: Balloon implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Achieving a Reduction of at Least 25% of the Volume of the Rectum Receiving at Least 70 Gy.
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.
Measured: 6 months
Secondary outcomes (1)
Rate of Occurrence of Grade 2 or Greater Rectal Adverse Event or Procedure Related Adverse Events.
Compare the rate of occurrence of rectal adverse events and implantation procedure related adverse events in balloon and control groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioProtect
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yossi Muncher, Dr., Study director, BioProtect
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918229
- Sponsor's protocol ID
- BPI-01 (USA)
- Status last verified
- Nov 2018
- First submitted
- 9 Jun 2009
- Last updated
- 20 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-arm, Multi-center, International Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
- ClinicalTrials.gov ID
- NCT00918229
- Acronym / sponsor ID
- BPI-01 (USA)
- Conditions
- Prostate Cancer
- Keywords
- Prostate, cancer, radiation, biodegradable implantable balloon, intrarectal balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BioProtectIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Posted 20 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Goal
The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine radiation therapy (XRT) treatment. Safety of the BioProtect device will be assessed by reporting adverse events.
Secondary Goal
The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum.
Detailed description
Primary Endpoint Parameters
The incidence of unexpected serious adverse events related to BioProtect's SpaceGuard balloon implant and/or implantation procedure:
- Serious Adverse Events related to the BioProtect balloon and/or implantation procedure were defined by the Clinical Trials.gov definition of a serious adverse event. Serious Adverse Events will be documented in Serious Adverse Event Form.
- Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events were documented in Adverse Event Form.
- Subjective discomfort related to the balloon and implantation procedure were assessed by a pain analogue scale.
Secondary Endpoint Parameters A 10% decrease or greater of the average rectal doses at V50 in at least 75% of the subjects after balloon implantation as compared to the doses at V50 before the balloon implantation. This was measured by routine Dose Volume Histogram (DVH) per local hospital practice and according to the instructions regarding anatomical landmarks delineated in this protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| balloon implantation | Other | Device: balloon implant, Procedure: Balloon implantationimplantation of an absorbable perirectal spacer balloon |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult male above 45 years old and less than 85.
- Diagnosed locally confined prostate cancer per hospital practice and definitions for local confined prostate cancer.
- Subject is scheduled for only localized prostate XRT treatments
- Zubrod performance status 0-1; or Karnofsy >80
- Blood CBC and biochemistry up to two weeks before screening demonstrating:
Key exclusion criteria (23 listed)
- Any prior prostate resection with a compliant prostate urethra as assessed by transrectal ultrasound (TRUS)
- Prior radical prostatectomy
- Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer
- Suspected extension of the prostate tumour toward the rectum as evidenced by acceptable imaging modalities used in the study site
- Prior surgical procedure involving peri-rectal and peri-prostatic area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balloon implantAbsorbable perirectal spacer implantation | Device | balloon implantation |
| Balloon implantationImplantation of the balloon between the prostate and the anterior rectal wall | Procedure or surgery | balloon implantation |
Primary outcome
Proportion of Subjects Achieving a Reduction of at Least 25% of the Volume of the Rectum Receiving at Least 70 Gy.
Time frame: 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.
1 secondary outcome
Rate of Occurrence of Grade 2 or Greater Rectal Adverse Event or Procedure Related Adverse Events.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yossi Muncher, Dr. study director
BioProtect
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balloon implant and Balloon implantation in people with Prostate Cancer, run by BioProtect at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Achieving a Reduction of at Least 25% of the Volume of the Rectum Receiving at Least 70 Gy. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.