Prostate CancerPhase 1NCT00061347
Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment
A Phase 1 study testing Fiducial marker placement in people with Prostate Cancer and Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
To effectively treat prostate cancer, doctors need an accurate view (via X-rays) of the prostate gland during radiation therapy. To help improve this view, doctors may insert gold markers called fiducials into the prostate by placing hollow gold needles through the rectum and moving a fiducial through each needle. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer, Cancer
- What is being tested?
- Fiducial marker placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2003to 19 Apr 2018
- 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 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed adenocarcinoma of the prostate gland.
- Age greater than or equal to 18 years.
- ECOG performance status of 0 or 1.
- Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include routine laboratory tests or imaging studies required to establish eligibility).
Who cannot join
- Patients with contraindication to transrectal needle placement:
- Bleeding disorder;
- PT/PTT greater than 1.5.times the upper limit of normal;
- Platelets less than 50K;
- Artificial heart valve.
- Patients with contraindications to MRI:
Show all 13Show fewer
- Patients weighing greater than 136 kg (weight limit for scanner table);
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or implanted electronic devices.
- Patients with chronic inflammatory bowel disease.
- Patients with distant metastatic disease.
- Patients with a prior history of pelvic or prostate radiotherapy.
- Cognitively impaired patients who cannot give informed consent.
- Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Trans-Rectal Placement of Prostatic Fiducial Markers Under MR-Guidance in Patients Receiving External Beam Radiotherapy for Prostate Cancer: A Pilot Study
To effectively treat prostate cancer, doctors need an accurate view (via X-rays) of the prostate gland during radiation therapy. To help improve this view, doctors may insert gold markers called fiducials into the prostate by placing hollow gold needles through the rectum and moving a fiducial through each needle. The purpose of the study is to determine whether an MRI scan can help doctors improve their placement of these needles.
Fifteen men will participate in this study. Patients will take the antibiotic levofloxacin for two days prior to the placement of the fiducials, then will have a small enema and another dose of the antibiotic on the morning of the procedure. After being anesthetized, patients will have an antenna-like tube placed into the rectum and have MRI images taken of the area. The doctor will then use these scans to place four fiducials into the prostate. The procedure will require approximately 45 minutes. Patients will be allowed to go home the same day of the procedure, which will be followed by a seven-week course of standard radiation therapy.
Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, blood work, urine tests, and, if appropriate, an MRI or bone scan.
Read the detailed description
Effective image-guided prostate therapies require excellent visualization of the prostate and surrounding anatomy, such that cancerous tissue can be treated while avoiding nearby neural and vascular structures. As such, Magnetic Resonance Imaging is well suited for image-guidance because of its excellent soft tissue contrast, multiplanar capabilities, and the potential to yield spectral/biological tumor mapping. Despite the potential for MRI-guided prostate therapies, there are currently no techniques that allow for precise trans-rectal intraprostatic needle placement in patients.
In this pilot study we seek to validate the accuracy and tolerability of a new system and technique that allows for accurate placement of needles within the prostate based upon MR images. The method is very similar to transrectal ultrasound guided biopsy of the prostate, except that it is applicable within a closed high-field MRI scanner. Four gold fiducial markers will be placed within the prostate under needle guidance in a series of patients with localized prostate cancer before external beam radiotherapy. Fifteen patients will be enrolled onto this study with sample size determined to obtain reasonably precise estimates of mean placement accuracy. The accrual period is expected to be less than a year.
While placement of the fiducial markers has no direct therapeutic benefit for the patient, intraprostatic radiopaque fiducial markers (placed under ultrasound) have shown value in assessing daily setup errors and off-line organ motion during external beam radiation therapy for prostate cancer. Therefore, a secondary objective is to gain experience using these intraprostatic fiducial markers for daily assessment and adjustment of external radiation beam targeting. These markers can also be utilized to aid in CT-MRI fusion and results in better target delineation for treatment planning. In this way, prostate cancer patients who are receiving external-beam radiation therapy may benefit from participation.
- Conditions
- Prostate Cancer, Cancer
- Being tested
- Fiducial marker placement
- Keywords
- Fiducial Marker, MRI, Prostate Cancer, Radiation
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiducial marker placementProcedure or surgery
Placement of fidicual markers under MRI guidance for localization of radiaiton treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Placement of fidicual markers under MRI guidance for localization of radiaiton treatment Receives: Procedure: Fiducial marker placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the hypothesis that MRI guidance allows for accurate fiducial marker placement within the prostate
Measured: 1, 3, 6, 12, 18, 24, 36, 48, and 60 months
To determine the toxicity of MR-Guided fiducial marker placement
Measured: 1, 3, 6, 12, 18, 24, 36, 48, and 60 months
Secondary outcomes (5)
To gain preliminary experience using intraprostatic fiducial markers for daily set-up assessment and adjustment of external radiation beam targeting.
Measured: completion of study
To gain preliminary experience using intraprostatic fiducial markers for image fusion.
Measured: completion of study
To measure the magnitude of marker migration during the course of radiotherapy.
Measured: completion of study
To gather data on radiation therapy effects on prostate cancer patients treated at the NCI ROB.
Measured: completion of study
To gather data on the feasibility, tolerability, and effectiveness of local anesthetic injection along the neurovascular bundle under MRI guidance.
Measured: completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2003 (estimated)
- Study start23 May 2003
- Primary completion31 May 2004
- Study completion19 Apr 2018
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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin A Camphausen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061347
- Sponsor's protocol ID
- 030190
- Other IDs
- 03-C-0190
- Status last verified
- 19 Apr 2018
- First submitted
- 23 May 2003
- Last updated
- 23 Apr 2018
- Results posted
- No
Publications
Yu KK, Hricak H. Imaging prostate cancer. Radiol Clin North Am. 2000 Jan;38(1):59-85, viii. doi: 10.1016/s0033-8389(05)70150-0.
PubMed 10664667Knopp MV, Weiss E, Sinn HP, Mattern J, Junkermann H, Radeleff J, Magener A, Brix G, Delorme S, Zuna I, van Kaick G. Pathophysiologic basis of contrast enhancement in breast tumors. J Magn Reson Imaging. 1999 Sep;10(3):260-6. doi: 10.1002/(sici)1522-2586(199909)10:33.0.co;2-7.
PubMed 10508285Kurhanewicz J, Vigneron DB, Hricak H, Narayan P, Carroll P, Nelson SJ. Three-dimensional H-1 MR spectroscopic imaging of the in situ human prostate with high (0.24-0.7-cm3) spatial resolution. Radiology. 1996 Mar;198(3):795-805. doi: 10.1148/radiology.198.3.8628874.
PubMed 8628874
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-Rectal Placement of Prostatic Fiducial Markers Under MR-Guidance in Patients Receiving External Beam Radiotherapy for Prostate Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT00061347
- Acronym / sponsor ID
- 030190
- Conditions
- Prostate Cancer, Cancer
- Keywords
- Fiducial Marker, MRI, Prostate Cancer, Radiation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 23 May 2003
- Primary completion
- 31 May 2004 (actual)
- Study completion
- 19 Apr 2018 (actual)
- First posted
- 26 May 2003 (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.
To effectively treat prostate cancer, doctors need an accurate view (via X-rays) of the prostate gland during radiation therapy. To help improve this view, doctors may insert gold markers called fiducials into the prostate by placing hollow gold needles through the rectum and moving a fiducial through each needle. The purpose of the study is to determine whether an MRI scan can help doctors improve their placement of these needles.
Fifteen men will participate in this study. Patients will take the antibiotic levofloxacin for two days prior to the placement of the fiducials, then will have a small enema and another dose of the antibiotic on the morning of the procedure. After being anesthetized, patients will have an antenna-like tube placed into the rectum and have MRI images taken of the area. The doctor will then use these scans to place four fiducials into the prostate. The procedure will require approximately 45 minutes. Patients will be allowed to go home the same day of the procedure, which will be followed by a seven-week course of standard radiation therapy.
Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, blood work, urine tests, and, if appropriate, an MRI or bone scan.
Detailed description
Effective image-guided prostate therapies require excellent visualization of the prostate and surrounding anatomy, such that cancerous tissue can be treated while avoiding nearby neural and vascular structures. As such, Magnetic Resonance Imaging is well suited for image-guidance because of its excellent soft tissue contrast, multiplanar capabilities, and the potential to yield spectral/biological tumor mapping. Despite the potential for MRI-guided prostate therapies, there are currently no techniques that allow for precise trans-rectal intraprostatic needle placement in patients.
In this pilot study we seek to validate the accuracy and tolerability of a new system and technique that allows for accurate placement of needles within the prostate based upon MR images. The method is very similar to transrectal ultrasound guided biopsy of the prostate, except that it is applicable within a closed high-field MRI scanner. Four gold fiducial markers will be placed within the prostate under needle guidance in a series of patients with localized prostate cancer before external beam radiotherapy. Fifteen patients will be enrolled onto this study with sample size determined to obtain reasonably precise estimates of mean placement accuracy. The accrual period is expected to be less than a year.
While placement of the fiducial markers has no direct therapeutic benefit for the patient, intraprostatic radiopaque fiducial markers (placed under ultrasound) have shown value in assessing daily setup errors and off-line organ motion during external beam radiation therapy for prostate cancer. Therefore, a secondary objective is to gain experience using these intraprostatic fiducial markers for daily assessment and adjustment of external radiation beam targeting. These markers can also be utilized to aid in CT-MRI fusion and results in better target delineation for treatment planning. In this way, prostate cancer patients who are receiving external-beam radiation therapy may benefit from participation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Fiducial marker placementPlacement of fidicual markers under MRI guidance for localization of radiaiton treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically confirmed adenocarcinoma of the prostate gland.
- Age greater than or equal to 18 years.
- ECOG performance status of 0 or 1.
- Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include routine laboratory tests or imaging studies required to establish eligibility).
Key exclusion criteria (13 listed)
- Bleeding disorder;
- PT/PTT greater than 1.5.times the upper limit of normal;
- Platelets less than 50K;
- Artificial heart valve.
- Patients weighing greater than 136 kg (weight limit for scanner table);
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 |
|---|---|---|
| Fiducial marker placementPlacement of fidicual markers under MRI guidance for localization of radiaiton treatment | Procedure or surgery | 1 |
Primary outcome
To test the hypothesis that MRI guidance allows for accurate fiducial marker placement within the prostate
Time frame: 1, 3, 6, 12, 18, 24, 36, 48, and 60 months
To determine the toxicity of MR-Guided fiducial marker placement
Time frame: 1, 3, 6, 12, 18, 24, 36, 48, and 60 months
5 secondary outcomes
To gain preliminary experience using intraprostatic fiducial markers for daily set-up assessment and adjustment of external radiation beam targeting.
Time frame: completion of study
To gain preliminary experience using intraprostatic fiducial markers for image fusion.
Time frame: completion of study
To measure the magnitude of marker migration during the course of radiotherapy.
Time frame: completion of study
To gather data on radiation therapy effects on prostate cancer patients treated at the NCI ROB.
Time frame: completion of study
To gather data on the feasibility, tolerability, and effectiveness of local anesthetic injection along the neurovascular bundle under MRI guidance.
Time frame: completion of study
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 23 Apr 2018.
- Background: PubMed 10664667Yu KK, Hricak H. Imaging prostate cancer. Radiol Clin North Am. 2000 Jan;38(1):59-85, viii. doi: 10.1016/s0033-8389(05)70150-0.
- Background: PubMed 10508285Knopp MV, Weiss E, Sinn HP, Mattern J, Junkermann H, Radeleff J, Magener A, Brix G, Delorme S, Zuna I, van Kaick G. Pathophysiologic basis of contrast enhancement in breast tumors. J Magn Reson Imaging. 1999 Sep;10(3):260-6. doi: 10.1002/(sici)1522-2586(199909)10:33.0.co;2-7.
- Background: PubMed 8628874Kurhanewicz J, Vigneron DB, Hricak H, Narayan P, Carroll P, Nelson SJ. Three-dimensional H-1 MR spectroscopic imaging of the in situ human prostate with high (0.24-0.7-cm3) spatial resolution. Radiology. 1996 Mar;198(3):795-805. doi: 10.1148/radiology.198.3.8628874.
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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.
Kevin A Camphausen, M.D. principal investigator
National Cancer Institute (NCI)
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 Fiducial marker placement in people with Prostate Cancer and Cancer, run by National Cancer Institute (NCI) 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 4 inclusion and 13 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 23 Apr 2018. 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.
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?
To test the hypothesis that MRI guidance allows for accurate fiducial marker placement within the prostate (time frame: 1, 3, 6, 12, 18, 24, 36, 48, and 60 months). The study lists 2 primary outcomes in all. 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 NCT00061347, 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 23 Apr 2018.