Prostate CancerPhase 1/2NCT01913197
Using Magnetic Resonance Imaging (MRI) to Guide Differential-Dose Prostate Brachytherapy
A Phase 1/2 study testing An MRI-based technique to identify prostate cancer in people with Prostate Cancer, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
In standard prostate brachytherapy treatment, the seeds are placed throughout the prostate to treat the entire gland. This is done because, in the past, it was impossible to know where the cancer was located within the prostate. 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?
- An MRI-based technique to identify prostate cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2016
- Phase
- Phase 1/2
- 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
Who may be able to join
- Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th Edition28
- PSA ≤ 15 ng/ml
- Gleason sum on biopsy ≤ 6 or 3+4=7
- Prostate volume ≤ 60 cc
- Willing to continue follow-up for at least two years
Who cannot join
- Prior hormone therapy
- Prior radiotherapy
- History of collagen vascular disease
- History of inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Lukes-Roosevelt Hospital Center
New York, New York
About this study
Official title: Phase I/II Evaluation Magnetic Resonance Imaging (MRI)-Guided Differential-Dose Prostate Brachytherapy
In standard prostate brachytherapy treatment, the seeds are placed throughout the prostate to treat the entire gland. This is done because, in the past, it was impossible to know where the cancer was located within the prostate. Multiparametric magnetic resonance imaging (MRI) can identify tumor(s) with a high degree of accuracy. This trial will assess whether using MRI to guide prostate brachytherapy can result in less chronic toxicity by allowing lower doses to be delivered to the regions of the prostate without tumor while simultaneously allowing higher doses to the tumor. Subjects enrolled in this study will then be followed over two years and evaluated for toxicity. In addition, after two years they will undergo an MRI and a biopsy to assess the cancer control rate of the treatment.
Read the detailed description
Prostate brachytherapy is a popular treatment for clinically localized prostate cancer. In properly selected patients, it is highly effective with biochemical (PSA) disease free survival rates of 85-95% at 5-10 years. However, the technique is currently limited by the inability to localize the cancer within the prostate. The multifocal nature of prostate cancer is well established. Because of the inability to know where within the prostate the cancer is located, radiation must be delivered throughout the gland. Although this blind approach leads to good results, it is clear that there are regions of the prostate and surrounding tissue that are overexposed to radiation while others are underexposed relative to their true need based on their tumor burden and their proximity to the tumor areas. Multiple studies have shown significant correlation between MRI abnormalities and radical prostatectomy specimens for determining size and location of cancer foci. MRI images have already begun to be incorporated into diagnostic and therapeutic procedures for prostate cancer on an experimental basis by other investigators. The images have been fused with real time TRUS to successfully perform targeted biopsies. In this study, we propose to use MRI images in the pre-treatment planning process to identify the tumors within the prostate prior to the brachytherapy and use these images to direct the dosimetry planning. The primary goal of this study is to decrease the chronic toxicities as assessed by the Common Toxicity Criteria Version 4.0 by decreasing the integral dose to the regions of the prostate which do not have tumor. A secondary goal is to increase the dose to the tumor(s) and demonstrate this ability while maintaining the urethral and other normal tissue doses. We also wish to perform dosimetric comparisons of the normal tissues and the tumor(s) when this technique is used compared to what would have been done if the patient had received a traditional implant. Finally, we propose to perform a prostate MRI followed by a biopsy to evaluate for persistent/recurrent disease at 2 years after treatment.
- Conditions
- Prostate Cancer
- Being tested
- An MRI-based technique to identify prostate cancer
- Keywords
- Prostate Brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An MRI-based technique to identify prostate cancerOther
| Study group | Role | What they receive |
|---|---|---|
| Pre-implant MRI images and planning | Experimental | Not described Receives: Other: An MRI-based technique to identify prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic toxicity as assessed by the Common Toxicity Criteria Version 4.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: low enrollment
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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald Ennis, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913197
- Sponsor's protocol ID
- 12-070
- Status last verified
- Jan 2017
- First submitted
- 29 Jul 2013
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Evaluation Magnetic Resonance Imaging (MRI)-Guided Differential-Dose Prostate Brachytherapy
- ClinicalTrials.gov ID
- NCT01913197
- Acronym / sponsor ID
- 12-070
- Conditions
- Prostate Cancer
- Keywords
- Prostate Brachytherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 31 Jul 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.
In standard prostate brachytherapy treatment, the seeds are placed throughout the prostate to treat the entire gland. This is done because, in the past, it was impossible to know where the cancer was located within the prostate. Multiparametric magnetic resonance imaging (MRI) can identify tumor(s) with a high degree of accuracy. This trial will assess whether using MRI to guide prostate brachytherapy can result in less chronic toxicity by allowing lower doses to be delivered to the regions of the prostate without tumor while simultaneously allowing higher doses to the tumor. Subjects enrolled in this study will then be followed over two years and evaluated for toxicity. In addition, after two years they will undergo an MRI and a biopsy to assess the cancer control rate of the treatment.
Detailed description
Prostate brachytherapy is a popular treatment for clinically localized prostate cancer. In properly selected patients, it is highly effective with biochemical (PSA) disease free survival rates of 85-95% at 5-10 years. However, the technique is currently limited by the inability to localize the cancer within the prostate. The multifocal nature of prostate cancer is well established. Because of the inability to know where within the prostate the cancer is located, radiation must be delivered throughout the gland. Although this blind approach leads to good results, it is clear that there are regions of the prostate and surrounding tissue that are overexposed to radiation while others are underexposed relative to their true need based on their tumor burden and their proximity to the tumor areas. Multiple studies have shown significant correlation between MRI abnormalities and radical prostatectomy specimens for determining size and location of cancer foci. MRI images have already begun to be incorporated into diagnostic and therapeutic procedures for prostate cancer on an experimental basis by other investigators. The images have been fused with real time TRUS to successfully perform targeted biopsies. In this study, we propose to use MRI images in the pre-treatment planning process to identify the tumors within the prostate prior to the brachytherapy and use these images to direct the dosimetry planning. The primary goal of this study is to decrease the chronic toxicities as assessed by the Common Toxicity Criteria Version 4.0 by decreasing the integral dose to the regions of the prostate which do not have tumor. A secondary goal is to increase the dose to the tumor(s) and demonstrate this ability while maintaining the urethral and other normal tissue doses. We also wish to perform dosimetric comparisons of the normal tissues and the tumor(s) when this technique is used compared to what would have been done if the patient had received a traditional implant. Finally, we propose to perform a prostate MRI followed by a biopsy to evaluate for persistent/recurrent disease at 2 years after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-implant MRI images and planning | Experimental | Other: An MRI-based technique to identify prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th Edition28
- PSA ≤ 15 ng/ml
- Gleason sum on biopsy ≤ 6 or 3+4=7
- Prostate volume ≤ 60 cc
- Willing to continue follow-up for at least two years
Key exclusion criteria (4 listed)
- Prior hormone therapy
- Prior radiotherapy
- History of collagen vascular disease
- History of inflammatory bowel disease
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 |
|---|---|---|
| An MRI-based technique to identify prostate cancer | Other | Pre-implant MRI images and planning |
Primary outcome
Chronic toxicity as assessed by the Common Toxicity Criteria Version 4.0
Time frame: 2 years
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 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.
Ronald Ennis, MD principal investigator
St. Luke's-Roosevelt Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing An MRI-based technique to identify prostate cancer in people with Prostate Cancer, run by St. Luke's-Roosevelt Hospital Center 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 5 inclusion and 4 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 6 Jan 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 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: low 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?
Chronic toxicity as assessed by the Common Toxicity Criteria Version 4.0 (time frame: 2 years). 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 6 Jan 2017.