Status:
COMPLETED
MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer
Lead Sponsor:
University Health Network, Toronto
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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.
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 ca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00448695
Start Date
March 1 2007
End Date
October 1 2008
Last Update
June 15 2012
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G2M9