MRI Targeted Focal Laser Thermal Therapy of Prostate Canc... | NCT00805883

Studies
MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy

NCT00805883

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

May 27, 2011Estimated

Enrollment

10Estimated

Phase

Phase 1

Conditions

Prostate Neoplasm

Interventions

Focal Phothtermal Ablation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Dec 8, 2008

First Submission Date that Met QC Criteria

Dec 9, 2008

First Posted Date

Dec 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2011

Last Update Posted Date

May 27, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Procedure: Focal Phothtermal Ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Focal Phothtermal Ablation	Procedure	Under general anasthesia and in Lithotomy position 2-4 14 Fr laser fibers will be placed into the prostate using 3D US guidance.	1

Measure	Description	Time Frame
Validity of MR/US Fusion and MR Targeting		7 Days after Focal Therapy

Eligibility Module

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;

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
John Trachtenberg, M.D	University Health Network, Toronto	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Princess Margaret Hospital		Toronto	Ontario	M5G 2M9	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20346578	Derived	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.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms