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

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.

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Key information

Conditions

Prostate Neoplasm Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Primary outcomes

Validity of MR/US Fusion and MR Targeting

Time frame: 7 Days after Focal Therapy

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Dec 10, 2008
Registry last updated: May 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed