Prostate CancerNCT01601691
Protection of Rectum From High Radiation Doses
A study testing DuraSeal in people with Prostate Cancer, run by University of Oulu at 1 site in Finland.
Trial summary
The purpose of this study is to evaluate the usefulness of 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 76 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- DuraSeal
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2012to Mar 2013
- 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 50 to 76 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
The purpose of this study is to evaluate the usefulness of 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. 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. 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, 4 weeks after the operation and 8 weeks after the operation. In addition, magnetic resonance imaging of pelvis performed 8 to 16 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.
- Conditions
- Prostate Cancer
- Being tested
- DuraSeal
- Keywords
- prostate cancer, brachytherapy, spacer, side effect
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuraSealDevice
Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
| Study group | Role | What they receive |
|---|---|---|
| Spacer | Experimental | Subjects with spacer injection Receives: Device: DuraSeal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spacer Volume Half Life
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 8 to 16 weeks after the operation in order to confirm the extent of spacer. Spacer volume half life is reported.
Measured: 1 day, 4 weeks, 8 weeks, up-to 16 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2013
- Study completionMar 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 10 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 Univeristy HospitalMerja Korpela, MD, Study chair, Oulu University HospitalVesa-Pekka Heikkilä, FL, Study chair, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601691
- Sponsor's protocol ID
- 241/2011
- Status last verified
- Nov 2014
- First submitted
- 14 May 2012
- Last updated
- 14 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Heikkila VP, Karna A, Vaarala MH. DuraSeal as a spacer to reduce rectal doses in low-dose rate brachytherapy for prostate cancer. Radiother Oncol. 2014 Aug;112(2):233-6. doi: 10.1016/j.radonc.2014.08.012. Epub 2014 Sep 4.
PubMed 25201125
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection of Rectum From High Radiation Doses
- ClinicalTrials.gov ID
- NCT01601691
- Acronym / sponsor ID
- 241/2011
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, brachytherapy, spacer, side effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Posted 14 Nov 2014
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 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. 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. 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, 4 weeks after the operation and 8 weeks after the operation. In addition, magnetic resonance imaging of pelvis performed 8 to 16 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spacer | Experimental | Device: DuraSealSubjects with spacer injection |
Who may qualify
- Ages
- 50 to 76 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 |
|---|---|---|
| DuraSealSingle dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate | Device | Spacer |
Primary outcome
Spacer Volume Half Life
Time frame: 1 day, 4 weeks, 8 weeks, up-to 16 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 8 to 16 weeks after the operation in order to confirm the extent of spacer. Spacer volume half life is reported.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25201125Heikkila VP, Karna A, Vaarala MH. DuraSeal as a spacer to reduce rectal doses in low-dose rate brachytherapy for prostate cancer. Radiother Oncol. 2014 Aug;112(2):233-6. doi: 10.1016/j.radonc.2014.08.012. Epub 2014 Sep 4.
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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 Univeristy Hospital
Merja Korpela, MD study chair
Oulu University Hospital
Vesa-Pekka Heikkilä, FL 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 DuraSeal in people with Prostate Cancer, 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: finished, as of the sponsor's last update on 14 Nov 2014. 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?
Yes. Results are posted in the registry (first posted 14 Nov 2014). 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?
Spacer Volume Half Life (time frame: 1 day, 4 weeks, 8 weeks, up-to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01601691, which also lists 1 linked publication.
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 14 Nov 2014.