Back to resultsMRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy
Primary Purpose
Prostate Neoplasm
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Focal Phothtermal Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Neoplasm focused on measuring Prostate Neoplasm, Localized, Photothermal, Radical Prostatectomy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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;
Sites / Locations
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Validity of MR/US Fusion and MR Targeting
Secondary Outcome Measures
Full Information
NCT ID
NCT00805883
First Posted
December 8, 2008
Last Updated
May 26, 2011
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00805883
Brief Title
MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy
Official Title
MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 Rectal US Guided Biopsy positive) will undergo an MRI scan to try to localize the tumour. If the MRI detects the tumour they will then undergo a perineal ablative procedure (ILTT) under general anaesthetic. Seven days following ILTT they will come back to the hospital for a Radical Retoropubic Prostatectomy (RRP) procedure, which is the removal of a prostate gland through a surgical incision. After removal, the prostate will undergo further analysis to determine the exact location of cancer and evaluate the extent of cancer death caused by ILTT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Neoplasm
Keywords
Prostate Neoplasm, Localized, Photothermal, Radical Prostatectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Focal Phothtermal Ablation
Intervention Description
Under general anasthesia and in Lithotomy position 2-4 14 Fr laser fibers will be placed into the prostate using 3D US guidance.
Primary Outcome Measure Information:
Title
Validity of MR/US Fusion and MR Targeting
Time Frame
7 Days after Focal Therapy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Trachtenberg, M.D
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
20346578
Citation
Lindner U, Lawrentschuk N, Weersink RA, Davidson SR, Raz O, Hlasny E, Langer DL, Gertner MR, Van der Kwast T, Haider MA, Trachtenberg J. Focal laser ablation for prostate cancer followed by radical prostatectomy: validation of focal therapy and imaging accuracy. Eur Urol. 2010 Jun;57(6):1111-4. doi: 10.1016/j.eururo.2010.03.008. Epub 2010 Mar 12.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/20346578
Description
Trial Results
Learn more about this trial
MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy
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