Stage I Prostate CancerNCT01792024
MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
A study testing Visualase Thermal Therapy and magnetic resonance imaging in people with Stage I Prostate Cancer and Stage II Prostate Carcinoma, run by University of Chicago at 1 site in United States.
Trial summary
This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Stage I Prostate Cancer, Stage II Prostate Carcinoma
- What is being tested?
- Visualase Thermal Therapy and magnetic resonance imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2013to 16 Sep 2015
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical characteristics:
- Stage T1c or T2a
- Prostate-specific antigen (PSA) < 15 ng/ml or PSA density (PSA divided by prostate volume in cubic centimeters) < 0.15 ng/ml^3
- No evidence of metastatic disease based on National Comprehensive Cancer Network (NCCN) guidelines:
- Bone scan if PSA > 20 ng/ml and clinical stage T1c
- Bone scan if PSA > 10 ng/ml and clinical stage T2
Show all 17Show fewer
- Biopsy requirements:
- Gleason score 7 or less
- 25% or fewer biopsies with cancer
- At least 12 biopsy cores of the prostate
- Within 12 months of treatment
- Imaging requirements:
- Up to 2 visible magnetic resonance (MR) lesion(s) concordant with sextant of biopsy-detected cancer(s)
- MRI within 6 months of treatment
- Karnofsky performance status of at least 70
- General health is suitable to undergo the planned minimally invasive procedures
- Risks, benefits, and alternatives discussed with informed consent given
Who cannot join
- Previous treatment of prostate cancer with luteinizing hormone releasing hormone (LHRH) agonist/antagonist, chemotherapy, surgery, or radiation
- Presence of 3 or more visible lesions on MRI
- High suspicion of seminal vesicle invasion or lymph node metastases on MRI
- Unable to tolerate MRI (medical device, foreign body, claustrophobia, body habitus, or other)
- Renal insufficiency with estimated glomerular filtration rate (eGFR) < 30 ml/min/body surface area (BSA) based on Modification in Diet Renal Disease equation; inability to safely receive gadolinium contrast for MRI
- History of prior pelvic surgery with surgical clips remaining in situ (e.g., bladder, bowel, internal pelvic organs) that compromise MRI image quality
- Other serious illnesses involving the cardiac, respiratory, central nervous system (CNS), or hepatic organ systems, which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470
About this study
Official title: Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer
This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the oncologic efficacy of laster interstitial thermal therapy (LITT) with primary endpoint of undetectable cancer on magnetic resonance imaging (MRI)-guided biopsy of treatment zone at 3 months following treatment.
SECONDARY OBJECTIVES:
- To evaluate oncologic efficacy at 12 months following treatment based on biopsy of the treatment zone.
II. To determine treatment-related safety and toxicity. III. To longitudinally assess urinary and sexual function in the year following treatment.
OUTLINE:
Patients undergo MR-guided LITT.
After completion of study treatment, patients are followed up at 1, 3, and 12 months.
- Being tested
- Visualase Thermal Therapy, magnetic resonance imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visualase Thermal TherapyDevice
Also called laser interstitial thermal therapy
MR guided laser ablation of prostate cancer
magnetic resonance imagingProcedure or surgery
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo MR-guided LITT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (LITT) | Experimental | Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device. Receives: Device: Visualase Thermal Therapy; Procedure: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment
The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.
Measured: At 3 months after ablation
Secondary outcomes (4)
The Number of Patients With Biopsy Cancer of the Treatment Zone
A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted.
Measured: At 12 months
The Total Number of Patients With Any Adverse Events Related to the Treatment
Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: 1,3, and 12 month after treatment and up to 12 months
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)
International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome.
Measured: At 1,3 and 12 months
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)
Sexual Health Inventory Score in Men (SHIM) measures sexual health and erectile function and it ranged 1 to 25. Lower values are considered better outcome.
Measured: At 1,3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start28 Jan 2013
- Primary completion16 Sep 2015
- Study completion16 Sep 2015
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.
- Other trials for Stage I Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aytekin Oto, Principal investigator, University of Chicago Comprehensive Cancer CenterScott Eggener, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792024
- Sponsor's protocol ID
- 12-1841
- Other IDs
- NCI-2013-00404, R21CA173751
- Status last verified
- Feb 2018
- First submitted
- 12 Feb 2013
- Last updated
- 13 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer
- ClinicalTrials.gov ID
- NCT01792024
- Acronym / sponsor ID
- 12-1841
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Jan 2013 (actual)
- Primary completion
- 16 Sep 2015 (actual)
- Study completion
- 16 Sep 2015 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Posted 13 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the oncologic efficacy of laster interstitial thermal therapy (LITT) with primary endpoint of undetectable cancer on magnetic resonance imaging (MRI)-guided biopsy of treatment zone at 3 months following treatment.
SECONDARY OBJECTIVES:
- To evaluate oncologic efficacy at 12 months following treatment based on biopsy of the treatment zone.
II. To determine treatment-related safety and toxicity. III. To longitudinally assess urinary and sexual function in the year following treatment.
OUTLINE:
Patients undergo MR-guided LITT.
After completion of study treatment, patients are followed up at 1, 3, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (LITT) | Experimental | Device: Visualase Thermal Therapy, Procedure: magnetic resonance imagingPatients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Clinical characteristics:
- No evidence of metastatic disease based on National Comprehensive Cancer Network (NCCN) guidelines:
- Biopsy requirements:
- Imaging requirements:
- Karnofsky performance status of at least 70
Key exclusion criteria (7 listed)
- Previous treatment of prostate cancer with luteinizing hormone releasing hormone (LHRH) agonist/antagonist, chemotherapy, surgery, or radiation
- Presence of 3 or more visible lesions on MRI
- High suspicion of seminal vesicle invasion or lymph node metastases on MRI
- Unable to tolerate MRI (medical device, foreign body, claustrophobia, body habitus, or other)
- Renal insufficiency with estimated glomerular filtration rate (eGFR) < 30 ml/min/body surface area (BSA) based on Modification in Diet Renal Disease equation; inability to safely receive gadolinium contrast for MRI
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 |
|---|---|---|
| Visualase Thermal TherapyAlso: laser interstitial thermal therapyMR guided laser ablation of prostate cancer | Device | Treatment (LITT) |
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo MR-guided LITT | Procedure or surgery | Treatment (LITT) |
Primary outcome
Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment
Time frame: At 3 months after ablation
The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.
4 secondary outcomes
The Number of Patients With Biopsy Cancer of the Treatment Zone
Time frame: At 12 months
The Total Number of Patients With Any Adverse Events Related to the Treatment
Time frame: 1,3, and 12 month after treatment and up to 12 months
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)
Time frame: At 1,3 and 12 months
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)
Time frame: At 1,3 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Aytekin Oto principal investigator
University of Chicago Comprehensive Cancer Center
Scott Eggener, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visualase Thermal Therapy and magnetic resonance imaging in people with Stage I Prostate Cancer and Stage II Prostate Carcinoma, run by University of Chicago 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 17 inclusion and 7 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 13 Mar 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2018). 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?
Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment (time frame: At 3 months after ablation). 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 13 Mar 2018.