Prostate TumorsNCT01743638
MR-Guided Laser Ablation of Prostate Bed Recurrences
A study testing MR-Guided Laser Ablation in people with Prostate Tumors, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to see if MR-guided laser ablation can effectively treat prostate tumor recurrences. Read more about this study
- Who is it for?
- Ages 50 to 95 years, men only
- Conditions the study is for
- Prostate Tumors
- What is being tested?
- MR-Guided Laser Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Feb 2014
- 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 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa referred to Urology and/or Interventional Radiology for treatment.
- Surgery is not a desirable alternative therapy at the time of enrollment
- Radiation therapy has failed or not indicated or can be safely postponed
- Tumor size ≤ 5 cm at its largest diameter
- Tumor does not encompass the rectal wall or external urethral sphincter
- Performance status is ECOG 2 or better in adults
- Patient is able to undergo MRI
Who cannot join
- Patients with pacemaker or defibrillator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Prostate Bed Recurrences
The purpose of this study is to see if MR-guided laser ablation can effectively treat prostate tumor recurrences.
- Conditions
- Prostate Tumors
- Being tested
- MR-Guided Laser Ablation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-Guided Laser AblationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MR-Guided Laser Ablation | Experimental | Not described Receives: Procedure: MR-Guided Laser Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of target lesion(s) dimensions at 3-6 month imaging follow-up
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate TumorsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Woodrum, Mayo Clinic
- Investigators
- David A. Woodrum, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743638
- Sponsor's protocol ID
- 09-001584
- Status last verified
- Apr 2014
- First submitted
- 4 Dec 2012
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Prostate Bed Recurrences
- ClinicalTrials.gov ID
- NCT01743638
- Acronym / sponsor ID
- 09-001584
- Conditions
- Prostate Tumors
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Dec 2012 (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 see if MR-guided laser ablation can effectively treat prostate tumor recurrences.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-Guided Laser Ablation | Experimental | Procedure: MR-Guided Laser Ablation |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa referred to Urology and/or Interventional Radiology for treatment.
- Surgery is not a desirable alternative therapy at the time of enrollment
- Radiation therapy has failed or not indicated or can be safely postponed
- Tumor size ≤ 5 cm at its largest diameter
- Tumor does not encompass the rectal wall or external urethral sphincter
Key exclusion criteria (1 listed)
- Patients with pacemaker or defibrillator
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 |
|---|---|---|
| MR-Guided Laser Ablation | Procedure or surgery | MR-Guided Laser Ablation |
Primary outcome
Measurement of target lesion(s) dimensions at 3-6 month imaging follow-up
Time frame: 3-6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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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.
David A. Woodrum, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-Guided Laser Ablation in people with Prostate Tumors, run by Mayo Clinic 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 7 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: withdrawn, as of the sponsor's last update on 10 Apr 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 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Measurement of target lesion(s) dimensions at 3-6 month imaging follow-up (time frame: 3-6 months). 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 10 Apr 2014.