Prostate CancerNCT00462124
Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
A study testing Absorbable perirectal spacer in people with Prostate Cancer, run by BioProtect at 1 site in Israel.
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 XRT treatment. Safety of the BioProtect device will be assessed by reporting adverse events. Read more about this study
- Who is it for?
- Ages Up to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Absorbable perirectal spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2007to May 2009
- 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 Up to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male aged ≤80.
- Men with child producing potential (that are not sterile) must accept using adequate contraceptive throughout the radiotherapy phase and for at least 3 months after completion of the radiotherapy phase when ever they have heterosexual intercourse.
- Diagnosed prostate cancer not spread outside the capsule (T1 and T2).
- Subject is scheduled for localized prostate XRT treatments.
- Zubrod performance status 0-1; or Karnofsy >80.
- Pre-randomization serum PSA lower than 25 (obtained prior to any LHRH or antiandrogen therapy); or Kattan nomogram less than 15 %.
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- Subject able to comprehend and give informed consent for participation in this study.
- Probability of lymph node involvement based on Kattan nomogram less than 15 %.
- Normal blood CBC and biochemistry up to two weeks before screening as follow:
- Normal CBC
- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin ≥ 10.0 g/dl
- Adequate renal function, with serum creatinine ≤ 2.0 mg/dl
- Adequate liver function, with serum bilirubin < 2.0 mg/dl
- Adequate liver function with SGOT/SGPT < 2.5 x the upper normal limit
- Normal values of the PT, PTT and INR tests.
- Signed Informed Consent Form.
Who cannot join
- Prior radical prostatectomy, cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer.
- Prior radiotherapy to the pelvis, including brachytherapy at the same body organ.
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.
- Transmural myocardial infarction within the last 6 months prior to screening.
- Acute infection requiring intravenous antibiotics at the time of screening.
- Bleeding disorders.
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- Uncontrolled diabetes mellitus
- HIV positive or any other immunosuppressive disorder.
- Renal failure (Serum creatinine >2.0 mg/dl).
- Inflammatory diseases of the perineal skin.
- Urinary tract infection or acute or chronic prostatitis.
- Active inflammatory bowel disease.
- Rectal carcinoma.
- Subjects after anterior resection of rectum or after rectal amputation.
- Known cognitive disorder.
- Concurrent participation in any other clinical study.
- Physician objection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One-arm, Multi-center, 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 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 safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure:
- Serious Adverse Events related to the BioProtect balloon and/or implantation procedure. Serious adverse event are defined as adverse requiring operation and/or associated with prolongation of hospital stay. Serious Adverse Events will be documented in Serious Adverse Event Form.
- Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events will be documented in Adverse Event Form.
- Subjective discomfort related to the balloon and implantation procedure will be assessed by pain analogue scale.
Secondary Endpoint Parameters
To assess the efficacy of BioProtect biodegradable balloon implant. Efficacy will be measured in terms of:
- Increased distance between anterior rectal wall and prostate post implantation as showed by CT until last radiation treatment.
- Noticeable reduction of isodose level to the rectum post implantation as compared to pre-implantation isodose to the rectum by XRT treatment planning software.
Other Measured Observations
- Balloon non-displacement during treatment phase as shown by CT.
- Balloon remaining inflated during treatment phase as shown by CT.
- Operator satisfaction from BioProtect balloon implantation procedure.
- Conditions
- Prostate Cancer
- Being tested
- Absorbable perirectal spacer
- 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.
Absorbable perirectal spacerDevice
biodegradable balloon implant to increase the distance between prostate and anterior rectal wall
| Study group | Role | What they receive |
|---|---|---|
| Balloon | Other | Implantation of a biodegradable balloon spacer (absorbable perirectal spacer) Receives: Device: Absorbable perirectal spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Balloon Implant
Assessed by collecting number of subjects experiencing a serious device related adverse event.
Measured: 6 months
Secondary outcomes (1)
Efficacy Will be Measured in Terms of: Number of Participants With a Reduction in Radiation to the Rectum
The space between the prostate and the rectum will be determined by Ct in subjects with prostate cancer who underwent radiotherapy and who received the balloon. The degree of increase in this space is directly related to a reduction of isodose level delivered to the rectum, and therefore a reduction in post radiation therapy rectal adverse event sequela.
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 posted18 Apr 2007 (estimated)
- Study startJun 2007
- Primary completionMar 2009
- Study completionMay 2009
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
- 7 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
- NCT00462124
- Sponsor's protocol ID
- BP-01
- Status last verified
- Feb 2018
- First submitted
- 16 Apr 2007
- Last updated
- 8 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-arm, Multi-center, Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
- ClinicalTrials.gov ID
- NCT00462124
- Acronym / sponsor ID
- BP-01
- Conditions
- Prostate Cancer
- Keywords
- Prostate, cancer, radiation, biodegradable implantable balloon, intrarectal balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- BioProtectIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Posted 8 Aug 2019
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 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 safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure:
- Serious Adverse Events related to the BioProtect balloon and/or implantation procedure. Serious adverse event are defined as adverse requiring operation and/or associated with prolongation of hospital stay. Serious Adverse Events will be documented in Serious Adverse Event Form.
- Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events will be documented in Adverse Event Form.
- Subjective discomfort related to the balloon and implantation procedure will be assessed by pain analogue scale.
Secondary Endpoint Parameters
To assess the efficacy of BioProtect biodegradable balloon implant. Efficacy will be measured in terms of:
- Increased distance between anterior rectal wall and prostate post implantation as showed by CT until last radiation treatment.
- Noticeable reduction of isodose level to the rectum post implantation as compared to pre-implantation isodose to the rectum by XRT treatment planning software.
Other Measured Observations
- Balloon non-displacement during treatment phase as shown by CT.
- Balloon remaining inflated during treatment phase as shown by CT.
- Operator satisfaction from BioProtect balloon implantation procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balloon | Other | Device: Absorbable perirectal spacerImplantation of a biodegradable balloon spacer (absorbable perirectal spacer) |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Male aged ≤80.
- Men with child producing potential (that are not sterile) must accept using adequate contraceptive throughout the radiotherapy phase and for at least 3 months after completion of the radiotherapy phase when ever they have heterosexual intercourse.
- Diagnosed prostate cancer not spread outside the capsule (T1 and T2).
- Subject is scheduled for localized prostate XRT treatments.
- Zubrod performance status 0-1; or Karnofsy >80.
Key exclusion criteria (17 listed)
- Prior radical prostatectomy, cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer.
- Prior radiotherapy to the pelvis, including brachytherapy at the same body organ.
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.
- Transmural myocardial infarction within the last 6 months prior to screening.
- Acute infection requiring intravenous antibiotics at the time of screening.
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 |
|---|---|---|
| Absorbable perirectal spacerbiodegradable balloon implant to increase the distance between prostate and anterior rectal wall | Device | Balloon |
Primary outcome
Safety of Balloon Implant
Time frame: 6 months
Assessed by collecting number of subjects experiencing a serious device related adverse event.
1 secondary outcome
Efficacy Will be Measured in Terms of: Number of Participants With a Reduction in Radiation to the Rectum
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 8 Aug 2019.
- 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 Absorbable perirectal spacer in people with Prostate Cancer, run by BioProtect at 1 site in Israel.
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 18 inclusion and 17 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 8 Aug 2019. 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 Israel. 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 8 Aug 2019). 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?
Safety of Balloon Implant (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 8 Aug 2019.