Prostate CancerPhase 1NCT00448695
MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer
A Phase 1 study testing MRI Targeted Focal Thermal Therapy of Prostate Cancer in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The objective of this study is to establish the safety of MRI targeted laser thermal treatment for men with biopsy confirmed early stage low grade single sector prostate cancer. 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?
- MRI Targeted Focal Thermal Therapy of Prostate Cancer
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to Oct 2008
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men > 18 years of age;
- Histologically-proven prostate carcinoma;
- Prostate cancer clinical stage T1c
- Only one sector of the prostate demonstrating prostate cancer with no more than 1 core positive
- Gleason score <7 ;
- Each core must range between of 10 to 50% adenocarcinoma.
Show all 31Show fewer
- Prostate MRI must confirm area suspicious for cancer in the sector of the positive biopsy;
- A minimum of six (6) weeks between the prostate biopsy and the Inclusion Visit;
- Prostate specific antigen (PSA) level £ 10 ng/mL
- PORPUS, IPSS, and IIEF complete prior to procedure
- Prostate volume < 60 cc as measured by ultra sound;
- Uroflow >12 cc/sec with post void residual < 100 cc.
- Life expectancy of greater than 5 years, based on co-morbidity not related to prostate cancer.
- Exclusion Criteria:Patients with any of the following exclusion criteria will be excluded from study participation:
- Patients who are unwilling or unable to give informed consent;
- Patients with foci location in the Apex of the prostate or isolated transition zone cancers
- Patients who have received androgen suppression therapy
- Patients who have received or are receiving chemotherapy for prostate carcinoma;
- Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive including HIFU, TUNA, RITA, microwave, TURP ,cryotherapy or any curative treatment
- Patients whose has undergone radiation therapy for prostate cancer
- Any condition, or history of illness or surgery that, in the opinion of the Investigator , might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies);
- Patients with a history of non compliance with medical therapy and/or medical recommendations;
- Patients who are unwilling or unable to complete the patient self-assessment questionnaires;
- Myocardial infarction, transient ischemic attack or stroke, within 6 months prior to the study, Unstable or uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias
- Chronic or acute prostititis, neuroginic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
- Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days;
- All medications that cause a decrease clotting, vasoconstriction or platelet aggregation, must be stopped prior to treatment.
- History of Colon Cancer or Colon Surgery preformed
- If the patient is unable to undergo anesthesia
- Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent).
- Any condition, or history of illness that, in the opinion of the investigator will confound or increase the patient risk during the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer
The objective of this study is to establish the safety of MRI targeted laser thermal treatment for men with biopsy confirmed early stage low grade single sector prostate cancer.
Read the detailed description
This is a single center, single arm, open-label Phase I study to establish the safety of interstitial laser thermal therapy (ILTT) in patients with a single site of low grade (Gleason <7) prostate cancer who have not yet received treatment for their cancer. No control group will be utilized and all patients will receive laser thermal therapy. The patient will undergo multimode MRI to determine if a single site of prostate cancer can be localized by this technique and to localize the tumor in 3 dimensions within the prostate. A multicore (12 + cores) mapping transrectal ultrasound guided biopsy of the prostate would then confirm that no other sites of cancer exist.
Each patient will complete quality of life and performance questionnaires. ILLT will be performed under general anesthetic in a procedure similar to brachytherapy, using transrectal ultrasound to guide insertion of the laser and monitoring probes into the sector containing the cancer as visualized by the MR scan. Following the procedure, patients will be assessed for clinical signs of urinary, rectal, and erectile complications and will complete validated self-assessment tools on these functions. MRI at 7 days and MRI and biopsy at 6 months will be used to assess the extent of tissue effect and presence of cancer due to ILTT. Patients will remain on standard Watchful Waiting surveillance for any further sign of disease progression. ILLT will not restrict any future treatment of prostate cancer.
To minimize the treatment risk, participants in the trial will be staged according to location of the disease in the prostate. The first 3 participants recruited to the trial will have targeted loci well separated from the urethra, erectile nerves and the rectum, and so treatment in this region poses minimal risk of injury to these vital structures. Lesions sizes measured in this initial stage will be used in planning fiber placement in the three remaining stages, in which fiber placement is closer to critical structures such as the urethra (Stage 2), erectile nerves (Stage 3) and rectum (Stage 4).
- Conditions
- Prostate Cancer
- Being tested
- MRI Targeted Focal Thermal Therapy of Prostate Cancer
- Keywords
- MRI, Laser Thermal Therapy, Focal Ablation, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI Targeted Focal Thermal Therapy of Prostate CancerProcedure or surgery
The Interstitial Laser Thermal Therapy (LTT) procedure is similar to brachytherapy, with fibers and probes inserted trans-perineal using transrectal ultrasound guidance. Patients will be under general anesthetic, and the procedure is expected to last 3 hours. Patients will be able to return home the day of the procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of: urinary, rectal, erectile function
Measured: 1 week, 1 month, 3 months, 6 months post procedure
validated self assessment tools of urinary, rectal, erectile function.
Measured: 1 month, 3 months, 6 months post procedure
Secondary outcomes (2)
Lesion size measured with 7-day MRI
Measured: One week post procedure
6 month prostate biopsy
Measured: 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2008
- Study completionOct 2008
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.
- More trials run by University Health Network, TorontoThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- John Trachtenberg, M.D., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448695
- Sponsor's protocol ID
- MRTA06-1
- Status last verified
- Jun 2012
- First submitted
- 16 Mar 2007
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer
- ClinicalTrials.gov ID
- NCT00448695
- Acronym / sponsor ID
- MRTA06-1
- Conditions
- Prostate Cancer
- Keywords
- MRI, Laser Thermal Therapy, Focal Ablation, Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Mar 2007 (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 objective of this study is to establish the safety of MRI targeted laser thermal treatment for men with biopsy confirmed early stage low grade single sector prostate cancer.
Detailed description
This is a single center, single arm, open-label Phase I study to establish the safety of interstitial laser thermal therapy (ILTT) in patients with a single site of low grade (Gleason <7) prostate cancer who have not yet received treatment for their cancer. No control group will be utilized and all patients will receive laser thermal therapy. The patient will undergo multimode MRI to determine if a single site of prostate cancer can be localized by this technique and to localize the tumor in 3 dimensions within the prostate. A multicore (12 + cores) mapping transrectal ultrasound guided biopsy of the prostate would then confirm that no other sites of cancer exist.
Each patient will complete quality of life and performance questionnaires. ILLT will be performed under general anesthetic in a procedure similar to brachytherapy, using transrectal ultrasound to guide insertion of the laser and monitoring probes into the sector containing the cancer as visualized by the MR scan. Following the procedure, patients will be assessed for clinical signs of urinary, rectal, and erectile complications and will complete validated self-assessment tools on these functions. MRI at 7 days and MRI and biopsy at 6 months will be used to assess the extent of tissue effect and presence of cancer due to ILTT. Patients will remain on standard Watchful Waiting surveillance for any further sign of disease progression. ILLT will not restrict any future treatment of prostate cancer.
To minimize the treatment risk, participants in the trial will be staged according to location of the disease in the prostate. The first 3 participants recruited to the trial will have targeted loci well separated from the urethra, erectile nerves and the rectum, and so treatment in this region poses minimal risk of injury to these vital structures. Lesions sizes measured in this initial stage will be used in planning fiber placement in the three remaining stages, in which fiber placement is closer to critical structures such as the urethra (Stage 2), erectile nerves (Stage 3) and rectum (Stage 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Men > 18 years of age;
- Histologically-proven prostate carcinoma;
- Prostate cancer clinical stage T1c
- Only one sector of the prostate demonstrating prostate cancer with no more than 1 core positive
- Gleason score <7 ;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MRI Targeted Focal Thermal Therapy of Prostate CancerThe Interstitial Laser Thermal Therapy (LTT) procedure is similar to brachytherapy, with fibers and probes inserted trans-perineal using transrectal ultrasound guidance. Patients will be under general anesthetic, and the procedure is expected to last 3 hours. Patients will be able to return home the day of the procedure. | Procedure or surgery | – |
Primary outcome
Clinical assessment of: urinary, rectal, erectile function
Time frame: 1 week, 1 month, 3 months, 6 months post procedure
validated self assessment tools of urinary, rectal, erectile function.
Time frame: 1 month, 3 months, 6 months post procedure
2 secondary outcomes
Lesion size measured with 7-day MRI
Time frame: One week post procedure
6 month prostate biopsy
Time frame: 6 months post procedure
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 15 Jun 2012.
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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.
John Trachtenberg, M.D. principal investigator
University Health Network, Toronto
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 MRI Targeted Focal Thermal Therapy of Prostate Cancer in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 31 inclusion and 0 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 15 Jun 2012. 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 Canada. 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?
Clinical assessment of: urinary, rectal, erectile function (time frame: 1 week, 1 month, 3 months, 6 months post procedure). 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?
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 15 Jun 2012.