Prostatic NeoplasmsNCT01918605
Protection of Rectum From High Radiation Doses Using a Spacer
A study testing Diluted spacer and Non-diluted spacer in people with Prostatic Neoplasms and Genital Neoplasms, Male, run by University of Oulu at 1 site in Finland.
Trial summary
The purpose of this study is to evaluate the usefulness of diluted and non-diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy. Read more about this study
- Who is it for?
- Ages 50 to 78 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms
- What is being tested?
- Diluted spacer and Non-diluted spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2013to Oct 2017
- Phase
- Interventional
- 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 50 to 78 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prostate cancer patients with planned low-dose brachytherapy for the treatment of prostate cancer
Who cannot join
- not willing to participate this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protection of Rectum From High Radiation Doses During Prostate Cancer Low-dose Brachytherapy Using Diluted or Non-diluted DuraSeal as a Spacer
The purpose of this study is to evaluate the usefulness of diluted and non-diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy.
Read the detailed description
Radiation therapy for prostate cancer leads to inappropriate radiation dose to the rectum wall leading rectum adverse effects in long term for some patients. A resorbable spaces between prostate and rectum could decrease the incidence of these side effect. In this trial, men with prostate cancer with intention to curative treatment by low-dose brachytherapy will be recruited. The subjects will be randomized to receive either diluted or non-diluted DuraSeal product as a spacer between prostate and rectum. Diluted or non-diluted DuraSeal will be applied between rectum and prostate at the end of the brachytherapy seed implantation procedure. After the implantation of the brachytherapy seeds, a needle is placed between rectum and prostate through perineal skin under transrectal ultrasound guidance. The proper position of the needle is confirmed by the injection of 10-15 ml sterile saline solution. After that, DuraSeal components are diluted in 1:1 with sterile saline and 6-10 ml of this diluted product will be injected using DuraSeal applicator. If the subject is randomized to receive non-diluted DuraSeal, the procedure will be identical with the exception the DuraSeal components will not be diluted. The resolution of the spacer will be followed by repeated plain computer tomography (CT) of pelvis performed a day before operation, a day after the operation, and 4, 8 and 12 weeks after the operation. In addition, magnetic resonance imaging of pelvis performed 12 weeks after the operation. The space created between prostate and rectum will be documented by plain CT and magnetic resonance imaging. Rectum radiation dose will be calculated based on these scans. Time to DuraSeal resolution will be evaluated from the scans. Possible side effects will be collected by subject interviews during follow-up visits at 4, 8 and 12 weeks after the operation.
- Being tested
- Diluted spacer, Non-diluted spacer
- Keywords
- prostate cancer, brachytherapy, spacer, side effect
- Medical subject headings
- Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diluted spacerDevice
Also called DuraSeal
Non-diluted spacerDevice
Also called DuraSeal
| Study group | Role | What they receive |
|---|---|---|
| Diluted spacer | Experimental | Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate Receives: Device: Diluted spacer |
| Non-diluted spacer | Active comparator | Single dose of DuraSeal product injected between rectum and prostate Receives: Device: Non-diluted spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spacer volume
Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 12 weeks after the operation in order to confirm the extent of spacer.
Measured: 1 day, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (2)
Side effects
Possible side effects will be collected by subject interview and physical examination on specified time frame.
Measured: 1 day, 4 weeks, 8 weeks, 12 weeks
Rectum radiation dose
Rectum dose will be calculated based on CT scans after brachytherapy.
Measured: 1 day, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: Insufficient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Principal investigator, Markku Vaarala, MD, PhD, University of Oulu
- Investigators
- Markku Vaarala, MD,PhD, Principal investigator, Oulu University HospitalMerja Korpela, MD, Study chair, Oulu University HospitalVesa-Pekka Heikkilä, PhL, Study chair, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918605
- Sponsor's protocol ID
- OY-111
- Status last verified
- Oct 2017
- First submitted
- 5 Aug 2013
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection of Rectum From High Radiation Doses During Prostate Cancer Low-dose Brachytherapy Using Diluted or Non-diluted DuraSeal as a Spacer
- ClinicalTrials.gov ID
- NCT01918605
- Acronym / sponsor ID
- OY-111
- Keywords
- prostate cancer, brachytherapy, spacer, side effect
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- Jun 2013 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 8 Aug 2013 (estimated)
- 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.
The purpose of this study is to evaluate the usefulness of diluted and non-diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy.
Detailed description
Radiation therapy for prostate cancer leads to inappropriate radiation dose to the rectum wall leading rectum adverse effects in long term for some patients. A resorbable spaces between prostate and rectum could decrease the incidence of these side effect. In this trial, men with prostate cancer with intention to curative treatment by low-dose brachytherapy will be recruited. The subjects will be randomized to receive either diluted or non-diluted DuraSeal product as a spacer between prostate and rectum. Diluted or non-diluted DuraSeal will be applied between rectum and prostate at the end of the brachytherapy seed implantation procedure. After the implantation of the brachytherapy seeds, a needle is placed between rectum and prostate through perineal skin under transrectal ultrasound guidance. The proper position of the needle is confirmed by the injection of 10-15 ml sterile saline solution. After that, DuraSeal components are diluted in 1:1 with sterile saline and 6-10 ml of this diluted product will be injected using DuraSeal applicator. If the subject is randomized to receive non-diluted DuraSeal, the procedure will be identical with the exception the DuraSeal components will not be diluted. The resolution of the spacer will be followed by repeated plain computer tomography (CT) of pelvis performed a day before operation, a day after the operation, and 4, 8 and 12 weeks after the operation. In addition, magnetic resonance imaging of pelvis performed 12 weeks after the operation. The space created between prostate and rectum will be documented by plain CT and magnetic resonance imaging. Rectum radiation dose will be calculated based on these scans. Time to DuraSeal resolution will be evaluated from the scans. Possible side effects will be collected by subject interviews during follow-up visits at 4, 8 and 12 weeks after the operation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diluted spacer | Experimental | Device: Diluted spacerSingle dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate |
| Non-diluted spacer | Active comparator | Device: Non-diluted spacerSingle dose of DuraSeal product injected between rectum and prostate |
Who may qualify
- Ages
- 50 to 78 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- prostate cancer patients with planned low-dose brachytherapy for the treatment of prostate cancer
Key exclusion criteria (1 listed)
- not willing to participate this study
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 |
|---|---|---|
| Diluted spacerAlso: DuraSeal | Device | Diluted spacer |
| Non-diluted spacerAlso: DuraSeal | Device | Non-diluted spacer |
Primary outcome
Change in spacer volume
Time frame: 1 day, 4 weeks, 8 weeks, 12 weeks
Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 12 weeks after the operation in order to confirm the extent of spacer.
2 secondary outcomes
Side effects
Time frame: 1 day, 4 weeks, 8 weeks, 12 weeks
Rectum radiation dose
Time frame: 1 day, 4 weeks, 8 weeks, 12 weeks
Results and safety
The study was stopped early (reason given: Insufficient enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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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.
Markku Vaarala, MD,PhD principal investigator
Oulu University Hospital
Merja Korpela, MD study chair
Oulu University Hospital
Vesa-Pekka Heikkilä, PhL study chair
Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diluted spacer and Non-diluted spacer in people with Prostatic Neoplasms and Genital Neoplasms, Male, run by University of Oulu at 1 site in Finland.
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 1 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: stopped early, as of the sponsor's last update on 27 Oct 2017. 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 Finland. 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 was stopped early (reason given: Insufficient enrollment.). Results are not available in the source record.
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?
Change in spacer volume (time frame: 1 day, 4 weeks, 8 weeks, 12 weeks). 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 27 Oct 2017.