Status:
COMPLETED
MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy
Lead Sponsor:
University Health Network, Toronto
Conditions:
Prostate Neoplasm
Eligibility:
MALE
40-80 years
Phase:
PHASE1
Brief Summary
This is a clinical research study designed to measure the effectiveness of focal Interstitial Laser Thermal Therapy (ILTT) at killing prostate tumours. Patients with "low risk" prostate cancer (Trans ...
Eligibility Criteria
Inclusion
- Men 40-80 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;
- A minimum of six (6) weeks between the prostate biopsy and the Inclusion Visit;
- Prostate specific antigen (PSA) level 15 ng/mL
Exclusion
- Medically unfit for Radical Retropubic Prostectomy (RRP) surgery
- 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 who have undergone radiation therapy for prostate cancer or to the pelvis
- 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;
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00805883
Start Date
February 1 2009
End Date
June 1 2010
Last Update
May 27 2011
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9