Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448695
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
2007-03-16
Brief Title:
MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Phase 1 Study of MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None