Prostate CancerNCT05423431
Retrospective Evaluation of a Commercially Available Hydrogel Spacer (BP-009)
An observational study of Prostate Cancer, run by BioProtect at 1 site in United States.
Trial summary
Dosimetry efficacy 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
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 30 Jun 2021
- 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 least 18 years of age
- Undergone external beam or brachy radiation therapy with a hydrogel spacer in place
Who cannot join
- Clinical and pathological data are not available
- Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Radiation Centers of New York ("ARC")
Lake Success, New York, 111042
About this study
Official title: Clinical Protocol for the Retrospective Evaluation of a Commercially Available Hydrogel Spacer
Dosimetry efficacy 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 up to 20 males who underwent radiotherapy treatment for prostate cancer. Study utilized pre and post gel insertion CT images to determine 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 underwent 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 as measured post hydrogel insertion based on CT simulation scans done after 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 posted21 Jun 2022
- Study start9 Nov 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioProtect
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423431
- Sponsor's protocol ID
- BP-009
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2022
- Last updated
- 24 Jun 2022
- 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 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Protocol for the Retrospective Evaluation of a Commercially Available Hydrogel Spacer
- ClinicalTrials.gov ID
- NCT05423431
- Acronym / sponsor ID
- BP-009
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Prostate Cancer, Spacer, Perirectal spacer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- BioProtectIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 21 Jun 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 of the hydrogel spacer.
Detailed description
Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in up to 20 males who underwent radiotherapy treatment for prostate cancer. Study utilized pre and post gel insertion CT images to determine endpoints.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation with Hydrogel Spacer | – | Other: ObservationMales at least 18 years of age, who underwent 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 least 18 years of age
- Undergone external beam or brachy radiation therapy with a hydrogel spacer in place
Key exclusion criteria (2 listed)
- Clinical and pathological data are not available
- 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 24 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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?
An observational study of 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 3 inclusion and 2 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 24 Jun 2022. 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?
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 24 Jun 2022.