Phase 1 Study of MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase 1 Study of MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer
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).
Inclusion Criteria:
- 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.
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical assessment of: urinary, rectal, erectile function
Outcome Time Frame:
1 week, 1 month, 3 months, 6 months post procedure
Safety Issue:
Yes
Principal Investigator
John Trachtenberg, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Toronto
Authority:
Canada: Health Canada
Study ID:
MRTA06-1
NCT ID:
NCT00448695
Start Date:
March 2007
Completion Date:
October 2008
Related Keywords:
- Prostate Cancer
- MRI
- Laser Thermal Therapy
- Focal Ablation
- Prostate Cancer
- Prostatic Neoplasms
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