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


Phase 1
40 Years
80 Years
Not Enrolling
Male
Prostate Neoplasm

Thank you

Trial Information

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


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;

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Validity of MR/US Fusion and MR Targeting

Outcome Time Frame:

7 Days after Focal Therapy

Safety Issue:

No

Principal Investigator

John Trachtenberg, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto

Authority:

Canada: Ethics Review Committee

Study ID:

FLTT 001

NCT ID:

NCT00805883

Start Date:

February 2009

Completion Date:

June 2010

Related Keywords:

  • Prostate Neoplasm
  • Prostate Neoplasm
  • Localized
  • Photothermal
  • Radical Prostatectomy
  • Neoplasms
  • Prostatic Neoplasms

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