Prostatic NeoplasmsPhase 1NCT00250224
Prostate Localization During Radiotherapy Using a Ni-Ti Stent and Electronic Portal Imaging - Protocol II
A Phase 1 study testing Radiotherapy stent in people with Prostatic Neoplasms, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
A new method for localization of the prostate during external beam radiotherapy. The method is based on insertion of a new thermo-expandable Ni-Ti stent. The radiological properties of the stent are used for precise prostate localization during treatment using electronic portal images Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Radiotherapy stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to May 2014
- Phase
- Phase 1
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients should present with histological verified local or locally advanced PC (stage T2b to T3b, N0, M0; UICC 1992 classification was used).
- Patients should consequently be candidates for intended curative radiotherapy -
Who cannot join
- dislocation or removal of stent
Trial locations and contacts
1 site in 1 country.
About this study
A new method for localization of the prostate during external beam radiotherapy. The method is based on insertion of a new thermo-expandable Ni-Ti stent. The radiological properties of the stent are used for precise prostate localization during treatment using electronic portal images
Read the detailed description
Inclusion criteria's in the study were 1) Patients should present with histological verified local or locally advanced PC (stage T2b to T3b, N0, M0; UICC 1992 classification was used). 2) Patients should consequently be candidates for intended curative radiotherapy. Prostatic work up is done before inclusion in the study. A new prostatic Nickel - Titanium stent is placed in the prostatic urethra one week prior to the radiotherapy planning CT using a flexible cystoscope to insert the stent under urethral anaesthesia. The stent is then flushed with hot water (60 degrees Celsius). The hot water expands the stent collar, thereby locking the stent in place. Correct positioning of the stent is secured visually on retraction of the scope. Radiotherapy of prostate is given to a mean dose of 70 (department standard regime). Treatment are given with daily fractions of 2 Gy using a combination of 6 MV and 18 MV X-ray fields using isocentric 3D conformal treatment plan, consisting of three MLC conformal radiation fields (One anterior and two lateral wedged fields). This was assumed to be the optimal treatment plan. A pair of orthogonal 15 cm x 15 cm isocenter setup fields was added to the plan. The orthogonal fields are used to obtain pairs of electronic portal images. Electronic portal images are recorded using a Varian As500 electronic portal imaging device (EPID). The images are used to determine the 3D reference position of the stent. The image pairs of the stent were taken at eight treatment sessions in each patient (Session number 1,2,3,6,11,21,22 and 23). From each orthogonal set of images the 3D position of both the stent and the symphysis (pubic bone) are determined. Positions are calculated using orthogonal reconstruction. A control CT scan is made before treatment session number 21 to verify the intra prostatic position of the stent. The intra prostatic position of the stent is also verified during removal of the stent three months after radiation therapy. Before removal the stent was flushed with water at 10 degrees Celsius. When cooled with 10°C cold water, the stent became super soft, and can easily be removed as a twisted wire.
- Conditions
- Prostatic Neoplasms
- Being tested
- Radiotherapy stent
- Keywords
- Radiotherapy, image guided, marker
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy stentDevice
| Study group | Role | What they receive |
|---|---|---|
| Stent | Experimental | Not described Receives: Device: Radiotherapy stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent in situ during radiotherapy
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startJan 2006
- Primary completionMay 2009
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesper Carl, PhD, Study chair, Dept medical Physics, Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250224
- Sponsor's protocol ID
- stent02
- Status last verified
- Sep 2005
- First submitted
- 7 Nov 2005
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carl J, Sander L. Five-year follow-up using a prostate stent as fiducial in image-guided radiotherapy of prostate cancer. Acta Oncol. 2015 Jun;54(6):862-7. doi: 10.3109/0284186X.2014.987355. Epub 2014 Dec 24.
PubMed 25539443Sander L, Langkilde NC, Holmberg M, Carl J. MRI target delineation may reduce long-term toxicity after prostate radiotherapy. Acta Oncol. 2014 Jun;53(6):809-14. doi: 10.3109/0284186X.2013.865077. Epub 2013 Dec 20.
PubMed 24358954Carl J, Nielsen J, Holmberg M, Larsen EH, Fabrin K, Fisker RV. Clinical results from first use of prostate stent as fiducial for radiotherapy of prostate cancer. Acta Oncol. 2011 May;50(4):547-54. doi: 10.3109/0284186X.2010.541935. Epub 2010 Dec 21.
PubMed 21174520
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Localization During Radiotherapy Using a Ni-Ti Stent and Electronic Portal Imaging - Protocol II
- ClinicalTrials.gov ID
- NCT00250224
- Acronym / sponsor ID
- stent02
- Conditions
- Prostatic Neoplasms
- Keywords
- Radiotherapy, image guided, marker
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Nov 2005 (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.
A new method for localization of the prostate during external beam radiotherapy. The method is based on insertion of a new thermo-expandable Ni-Ti stent. The radiological properties of the stent are used for precise prostate localization during treatment using electronic portal images
Detailed description
Inclusion criteria's in the study were 1) Patients should present with histological verified local or locally advanced PC (stage T2b to T3b, N0, M0; UICC 1992 classification was used). 2) Patients should consequently be candidates for intended curative radiotherapy. Prostatic work up is done before inclusion in the study. A new prostatic Nickel - Titanium stent is placed in the prostatic urethra one week prior to the radiotherapy planning CT using a flexible cystoscope to insert the stent under urethral anaesthesia. The stent is then flushed with hot water (60 degrees Celsius). The hot water expands the stent collar, thereby locking the stent in place. Correct positioning of the stent is secured visually on retraction of the scope. Radiotherapy of prostate is given to a mean dose of 70 (department standard regime). Treatment are given with daily fractions of 2 Gy using a combination of 6 MV and 18 MV X-ray fields using isocentric 3D conformal treatment plan, consisting of three MLC conformal radiation fields (One anterior and two lateral wedged fields). This was assumed to be the optimal treatment plan. A pair of orthogonal 15 cm x 15 cm isocenter setup fields was added to the plan. The orthogonal fields are used to obtain pairs of electronic portal images. Electronic portal images are recorded using a Varian As500 electronic portal imaging device (EPID). The images are used to determine the 3D reference position of the stent. The image pairs of the stent were taken at eight treatment sessions in each patient (Session number 1,2,3,6,11,21,22 and 23). From each orthogonal set of images the 3D position of both the stent and the symphysis (pubic bone) are determined. Positions are calculated using orthogonal reconstruction. A control CT scan is made before treatment session number 21 to verify the intra prostatic position of the stent. The intra prostatic position of the stent is also verified during removal of the stent three months after radiation therapy. Before removal the stent was flushed with water at 10 degrees Celsius. When cooled with 10°C cold water, the stent became super soft, and can easily be removed as a twisted wire.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stent | Experimental | Device: Radiotherapy stent |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients should present with histological verified local or locally advanced PC (stage T2b to T3b, N0, M0; UICC 1992 classification was used).
- Patients should consequently be candidates for intended curative radiotherapy -
Key exclusion criteria (1 listed)
- dislocation or removal of stent
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 |
|---|---|---|
| Radiotherapy stent | Device | Stent |
Primary outcome
stent in situ during radiotherapy
Time frame: 8 weeks
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 26 Jun 2015.
- Background: PubMed 25539443Carl J, Sander L. Five-year follow-up using a prostate stent as fiducial in image-guided radiotherapy of prostate cancer. Acta Oncol. 2015 Jun;54(6):862-7. doi: 10.3109/0284186X.2014.987355. Epub 2014 Dec 24.
- Background: PubMed 24358954Sander L, Langkilde NC, Holmberg M, Carl J. MRI target delineation may reduce long-term toxicity after prostate radiotherapy. Acta Oncol. 2014 Jun;53(6):809-14. doi: 10.3109/0284186X.2013.865077. Epub 2013 Dec 20.
- Background: PubMed 21174520Carl J, Nielsen J, Holmberg M, Larsen EH, Fabrin K, Fisker RV. Clinical results from first use of prostate stent as fiducial for radiotherapy of prostate cancer. Acta Oncol. 2011 May;50(4):547-54. doi: 10.3109/0284186X.2010.541935. Epub 2010 Dec 21.
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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.
Jesper Carl, PhD study chair
Dept medical Physics, Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiotherapy stent in people with Prostatic Neoplasms, run by Aalborg University Hospital at 1 site in Denmark.
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 2 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 26 Jun 2015. 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 Denmark. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
stent in situ during radiotherapy (time frame: 8 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 NCT00250224, which also lists 3 linked publications.
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 26 Jun 2015.