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

NCT00805883 | Completed Phase 1

• 1 other identifier: FLTT 001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Neoplasm

Keywords

Prostate Neoplasm; Localized; Photothermal; Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Validity of MR/US Fusion and MR Targeting

  7 Days after Focal Therapy

Study Arms (1)

1

EXPERIMENTAL

Procedure: Focal Phothtermal Ablation

Interventions

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Prostate specific antigen (PSA) level 15 ng/mL

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• 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.

  PMID: 20346578 DERIVED

Related Links

• Trial Results

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• John Trachtenberg, M.D

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 10, 2008
• Study Start: February 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 27, 2011

Record last verified: 2008-12

Locations

CA (1)