Prostate CancerBP-008NCT05323747
Prospective Evaluation of a Commercially Available Hydrogel Spacer
An observational study of Prostate Cancer, run by BioProtect at 2 sites in United States.
Trial summary
Dosimetry efficacy evaluation of the hydrogel spacer 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?
- Observation
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Nov 2020to 8 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Prostate Cancer
Who may be able to join
- Males
- At lease 18 years of age
- Undergoing external beam or brachy radiation therapy with a hydrogel spacer
Who cannot join
- Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Western Radiation Oncology
Campbell, California, 95008
Northern Nevada Radiation Oncology
Reno, Nevada, 89521
About this study
Official title: Clinical Protocol for the Prospective Evaluation of a Commercially Available Hydrogel Spacer
Dosimetry efficacy evaluation of the hydrogel spacer
Read the detailed description
Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in 20 males undergoing radiotherapy to treat prostate cancer. Study will utilize pre and post gel insertion CT images to determine the endpoints.
- Conditions
- Prostate Cancer
- Being tested
- Observation
- Keywords
- Prostate, Prostate Cancer, Spacer, Perirectal spacer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Assessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with a hydrogel spacer.
| Study group | Role | What they receive |
|---|---|---|
| Radiation with Hydrogel Spacer | Males at least 18 years of age, who will be undergoing radiation therapy with a hydrogel spacer in place. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetry changes
Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post Hydrogel Injection
Measured: 1 month
Secondary outcomes (1)
Prostate to rectum spacing
Prostate to rectum spacing measurement for evaluation of the perirectal distance post-hydrogel insertion
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start20 Nov 2020
- Primary completion29 Jun 2021
- Study completion8 Feb 2022
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioProtect
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323747
- Sponsor's protocol ID
- BP-008
- Acronym
- BP-008
- Status last verified
- Apr 2022
- First submitted
- 17 Mar 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Protocol for the Prospective Evaluation of a Commercially Available Hydrogel Spacer
- ClinicalTrials.gov ID
- NCT05323747
- Acronym / sponsor ID
- BP-008 / BP-008
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Prostate Cancer, Spacer, Perirectal spacer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BioProtectIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 12 Apr 2022 (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.
Dosimetry efficacy evaluation of the hydrogel spacer
Detailed description
Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in 20 males undergoing radiotherapy to treat prostate cancer. Study will utilize pre and post gel insertion CT images to determine the endpoints.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation with Hydrogel Spacer | – | Other: ObservationMales at least 18 years of age, who will be undergoing radiation therapy with a hydrogel spacer in place. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate Cancer
Key inclusion criteria (3 listed)
- Males
- At lease 18 years of age
- Undergoing external beam or brachy radiation therapy with a hydrogel spacer
Key exclusion criteria (1 listed)
- Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension
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 |
|---|---|---|
| ObservationAssessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with a hydrogel spacer. | Other | Radiation with Hydrogel Spacer |
Primary outcome
Dosimetry changes
Time frame: 1 month
Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post Hydrogel Injection
1 secondary outcome
Prostate to rectum spacing
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by BioProtect at 2 sites 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 3 inclusion and 1 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 changes (time frame: 1 month). 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 16 Sep 2025.