Prostate CancerFLTT002NCT01094665
MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer
A study testing MRI Targeted Focal Laser Thermal Therapy in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The primary objective of this study is to evaluate the safety and feasibility of Magnetic Resonance Image (MRI) guided focal prostate cancer laser thermal ablation in males, ages 40-80 with biopsy confirmed early clinical stage prostate cancer (T1c or T2a) with an identifiable lesion on mutliparametric MRI, with a… Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI Targeted Focal Laser Thermal Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to 8 Oct 2015
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men 45-80 years of age;
- Histologically proven prostate carcinoma;
- Prostate cancer clinical stage T1c and T2a
- Prostate MRI must confirm area suspicious for cancer in the sector of the positive biopsy;
- Prostate specific antigen (PSA) level less than 15 ng/mL
- 12 cores biopsy, with histologically proven prostate carcinoma, in the suspicious region on MRI.
- IPSS and IIEF complete prior to procedure
- Life expectancy of greater than 5 years, based on co-morbidity not related to prostate cancer.
Who cannot join
- Medically unfit for focal therapy of the prostate
- Patients who are unwilling or unable to give informed consent;
- 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 who have undergone radiation therapy for prostate cancer or to the pelvis
Show all 14Show fewer
- 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;
- Chronic or acute prostatitis, neurogenic 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;
- If the patient is unable to undergo regional 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Princess Margaret Hospital, University Health Network
Toronto, Ontario, M5G2M9
About this study
Official title: Phase 1 Study of MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer
The primary objective of this study is to evaluate the safety and feasibility of Magnetic Resonance Image (MRI) guided focal prostate cancer laser thermal ablation in males, ages 40-80 with biopsy confirmed early clinical stage prostate cancer (T1c or T2a) with an identifiable lesion on mutliparametric MRI, with a Prostate Specific Antigen (PSA) of < 15ng/ml, who have not yet undergone pelvic radiation or hormonal deprivation therapy.
Read the detailed description
This is a single center, single arm, open-label study to evaluate the safety and feasibility of MRI guided focal prostate cancer laser ablation in patients with a focus of prostate cancer who has not yet received treatment for their cancer. Patients fulfilling the inclusion criteria and having none of the clinical exclusion criteria will be enrolled into the study after they (or their legal representative) have signed the informed consent form. No control group will be utilized and all patients will receive MRI guided FLA for their focal prostate cancer. As part of the screening process, patients will provide a medical history and undergo a physical examination, including a digital rectal examination (DRE). At the first visit, patients will also be given a copy of the informed consent, and a copy of quality of life and performance questionnaires to assess urinary, rectal, and erectile functions (IPSS questionnaire for urinary, IIEF5 questionnaire for erectile function, for all). MR imaging at visit 2 will serve to determine if a single site of prostate cancer can be localized. At visit 3, 12 cores transrectal us guided prostate biopsy will confirm yet again that this is a unilateral, unifocal histologically proven tumour in the site recognized on the MRI. On preoperative examination (visit 4) - blood and urine samples will be taken prior to procedure. Visit 5 - the focal treatment will be performed under regional or general anesthesia, or conscious sedation, (as determined by the anesthesiologist) in the TGH research 1.5T MRI suite. MR guided FLA procedure is similar to MR guided brachytherapy, with fibers and probes inserted transperineally outside the bore of the MR and then the patient is moved inside the bore to verify position before deploying the laser. The treatment is expected to last 2-3 hours, and patients expected to have no pain during the whole procedure. Laser ablation will be monitored using MR thermometry14, 15.An MRI scan will be done immediately after the ablation, as initial assessment for ensuring complete treatment of the target volume, as well as ensuring that treatment does not extend to critical structures.
The size and location of the lesion will be compared to the planned target volume and the proximity of the lesion to the urethra and rectum. If the lesion does not encompass the target volume, and is still a safe distance from either critical structure, FLA may be continued.
On day 3, 7, 30, and 120 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. Free/Total PSA will be monitor on visit -1 and after the treatment on day 7, 30 and 120, in order to try to understand the effect of FLA on PSA. Four months after the focal procedure, a further 12 cores biopsy, plus 2 cores aimed to the ablated lesion will then be preformed to verify the oncological effectiveness of the treatment.
- Conditions
- Prostate Cancer
- Being tested
- MRI Targeted Focal Laser Thermal Therapy
- 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 Laser Thermal TherapyProcedure or surgery
A 980nm wavelength diode laser will be fired for up to 30 minutes. Temperature probes will be inserted to ensure that the local temperature does not exceed 55 degrees Celsius for more than 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Focal Laser Thermal Therapy | Experimental | Thermal therapy delivered to lesion visible on MRI. Receives: Procedure: MRI Targeted Focal Laser Thermal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transrectal Ultrasound Guided Prostate Biopsy
A 12 core biopsy, plus 2 cores aimed at the ablated lesion will then be preformed to verify the oncological effectiveness of the treatment.
Measured: 4 Months Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startNov 2009
- Primary completion8 Oct 2015
- Study completion8 Oct 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094665
- Sponsor's protocol ID
- 09-0689-C
- Acronym
- FLTT002
- Status last verified
- Mar 2018
- First submitted
- 25 Mar 2010
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. 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 Prostate Cancer
- ClinicalTrials.gov ID
- NCT01094665
- Acronym / sponsor ID
- FLTT002 / 09-0689-C
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- 8 Oct 2015 (actual)
- Study completion
- 8 Oct 2015 (actual)
- First posted
- 29 Mar 2010 (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 primary objective of this study is to evaluate the safety and feasibility of Magnetic Resonance Image (MRI) guided focal prostate cancer laser thermal ablation in males, ages 40-80 with biopsy confirmed early clinical stage prostate cancer (T1c or T2a) with an identifiable lesion on mutliparametric MRI, with a Prostate Specific Antigen (PSA) of < 15ng/ml, who have not yet undergone pelvic radiation or hormonal deprivation therapy.
Detailed description
This is a single center, single arm, open-label study to evaluate the safety and feasibility of MRI guided focal prostate cancer laser ablation in patients with a focus of prostate cancer who has not yet received treatment for their cancer. Patients fulfilling the inclusion criteria and having none of the clinical exclusion criteria will be enrolled into the study after they (or their legal representative) have signed the informed consent form. No control group will be utilized and all patients will receive MRI guided FLA for their focal prostate cancer. As part of the screening process, patients will provide a medical history and undergo a physical examination, including a digital rectal examination (DRE). At the first visit, patients will also be given a copy of the informed consent, and a copy of quality of life and performance questionnaires to assess urinary, rectal, and erectile functions (IPSS questionnaire for urinary, IIEF5 questionnaire for erectile function, for all). MR imaging at visit 2 will serve to determine if a single site of prostate cancer can be localized. At visit 3, 12 cores transrectal us guided prostate biopsy will confirm yet again that this is a unilateral, unifocal histologically proven tumour in the site recognized on the MRI. On preoperative examination (visit 4) - blood and urine samples will be taken prior to procedure. Visit 5 - the focal treatment will be performed under regional or general anesthesia, or conscious sedation, (as determined by the anesthesiologist) in the TGH research 1.5T MRI suite. MR guided FLA procedure is similar to MR guided brachytherapy, with fibers and probes inserted transperineally outside the bore of the MR and then the patient is moved inside the bore to verify position before deploying the laser. The treatment is expected to last 2-3 hours, and patients expected to have no pain during the whole procedure. Laser ablation will be monitored using MR thermometry14, 15.An MRI scan will be done immediately after the ablation, as initial assessment for ensuring complete treatment of the target volume, as well as ensuring that treatment does not extend to critical structures.
The size and location of the lesion will be compared to the planned target volume and the proximity of the lesion to the urethra and rectum. If the lesion does not encompass the target volume, and is still a safe distance from either critical structure, FLA may be continued.
On day 3, 7, 30, and 120 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. Free/Total PSA will be monitor on visit -1 and after the treatment on day 7, 30 and 120, in order to try to understand the effect of FLA on PSA. Four months after the focal procedure, a further 12 cores biopsy, plus 2 cores aimed to the ablated lesion will then be preformed to verify the oncological effectiveness of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal Laser Thermal Therapy | Experimental | Procedure: MRI Targeted Focal Laser Thermal TherapyThermal therapy delivered to lesion visible on MRI. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men 45-80 years of age;
- Histologically proven prostate carcinoma;
- Prostate cancer clinical stage T1c and T2a
- Prostate MRI must confirm area suspicious for cancer in the sector of the positive biopsy;
- Prostate specific antigen (PSA) level less than 15 ng/mL
Key exclusion criteria (14 listed)
- Medically unfit for focal therapy of the prostate
- Patients who are unwilling or unable to give informed consent;
- 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
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 Laser Thermal TherapyA 980nm wavelength diode laser will be fired for up to 30 minutes. Temperature probes will be inserted to ensure that the local temperature does not exceed 55 degrees Celsius for more than 5 minutes. | Procedure or surgery | Focal Laser Thermal Therapy |
Primary outcome
Transrectal Ultrasound Guided Prostate Biopsy
Time frame: 4 Months Post Treatment
A 12 core biopsy, plus 2 cores aimed at the ablated lesion will then be preformed to verify the oncological effectiveness of the treatment.
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 9 Mar 2018.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI Targeted Focal Laser Thermal Therapy 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 8 inclusion and 14 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 9 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 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.
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?
Transrectal Ultrasound Guided Prostate Biopsy (time frame: 4 Months Post Treatment). 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 9 Mar 2018.