Prostate CancerNCT06599476
Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy
A study testing BioProtect Balloon Implant™ System in people with Prostate Cancer, run by Advanced Radiation Centers of New York at 1 site in United States.
Trial summary
This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement. The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- BioProtect Balloon Implant™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with prostate cancer ≥ 18 years of age.
- Patients are in one of the following risk groups:
- T1-T3 prostate cancer with no posterior extra capsular extension
- Gleason score ≤ 7
- Planned for radiation treatment with rectal spacer.
- Ability to understand and the willingness to sign a written informed consent form.
Who cannot join
- Metastatic disease.
- Previously treated localized adenocarcinoma of the prostate.
- Active Inflammatory bowel disease requiring treatment with steroids.
- Prior total prostatectomy.
- Current urinary tract infection.
- Acute or chronic prostatitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Radiation Centers of New York
New Hyde Park, New York, 11042
About this study
Official title: Use of Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy: a Prospective Clinical Study
This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement.
The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer.
Study visits:
- Screening
- Spacer placement
- Treatment planning simulation
- End of the radiation treatment
- 1, 3, 6, 12, 18 and 24-months FU visits.
- Conditions
- Prostate Cancer
- Being tested
- BioProtect Balloon Implant™ System
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioProtect Balloon Implant™ SystemDevice
The BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, and by creating this space, to reduce the radiation dose delivered to the anterior rectum. The balloon is inserted into the perirectal space and inflated to its pre-defined size. The Balloon is made of biodegradable materials that maintain the space for the entire course of prostate radiation treatment and are absorbed by the patient's body over time
| Study group | Role | What they receive |
|---|---|---|
| BioProtect Balloon Implant System | Experimental | The Bio Protect Balloon Implant System (BioProtectLtd.,TzurYigal,Israel) is an Food and Drug Administration approved rectal spacer that consists of a solid biodegradable balloon-shaped material composed of poly L-Lactide-co-caprolactone Receives: Device: BioProtect Balloon Implant™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetry
Dose-volume histogram (DVH) including the percent of the rectal volume receiving 70 Gy
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 posted19 Sep 2024
- Study start21 May 2024
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Radiation Centers of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn Zimberg, MD, Advanced Radiation Centers of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599476
- Sponsor's protocol ID
- 1372621
- Status last verified
- Jun 2026
- First submitted
- 26 Aug 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy: a Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06599476
- Acronym / sponsor ID
- 1372621
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Advanced Radiation Centers of New YorkUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement.
The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer.
Study visits:
- Screening
- Spacer placement
- Treatment planning simulation
- End of the radiation treatment
- 1, 3, 6, 12, 18 and 24-months FU visits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioProtect Balloon Implant System | Experimental | Device: BioProtect Balloon Implant™ SystemThe Bio Protect Balloon Implant System (BioProtectLtd.,TzurYigal,Israel) is an Food and Drug Administration approved rectal spacer that consists of a solid biodegradable balloon-shaped material composed of poly L-Lactide-co-caprolactone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with prostate cancer ≥ 18 years of age.
- Patients are in one of the following risk groups:
- Planned for radiation treatment with rectal spacer.
- Ability to understand and the willingness to sign a written informed consent form.
Key exclusion criteria (6 listed)
- Metastatic disease.
- Previously treated localized adenocarcinoma of the prostate.
- Active Inflammatory bowel disease requiring treatment with steroids.
- Prior total prostatectomy.
- Current urinary tract infection.
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 |
|---|---|---|
| BioProtect Balloon Implant™ SystemThe BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, and by creating this space, to reduce the radiation dose delivered to the anterior rectum. The balloon is inserted into the perirectal space and inflated to its pre-defined size. The Balloon is made of biodegradable materials that maintain the space for the entire course of prostate radiation treatment and are absorbed by the patient's body over time | Device | BioProtect Balloon Implant System |
Primary outcome
Dosimetry
Time frame: 6 months
Dose-volume histogram (DVH) including the percent of the rectal volume receiving 70 Gy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioProtect Balloon Implant™ System in people with Prostate Cancer, run by Advanced Radiation Centers of New York 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Dosimetry (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 25 Jun 2026.