MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer

NCT00448695 | Completed Phase 1

• 1 other identifier: MRTA06-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

MRI; Laser Thermal Therapy; Focal Ablation; Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Clinical assessment of: urinary, rectal, erectile function

  1 week, 1 month, 3 months, 6 months post procedure

• validated self assessment tools of urinary, rectal, erectile function.

  1 month, 3 months, 6 months post procedure

Secondary Outcomes (2)

• Lesion size measured with 7-day MRI

  One week post procedure

• 6 month prostate biopsy

  6 months post procedure

Interventions

MRI Targeted Focal Thermal Therapy of Prostate Cancer PROCEDURE

The Interstitial Laser Thermal Therapy (LTT) procedure is similar to brachytherapy, with fibers and probes inserted trans-perineal using transrectal ultrasound guidance. Patients will be under general anesthetic, and the procedure is expected to last 3 hours. Patients will be able to return home the day of the procedure.

Eligibility Criteria

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

You may qualify if:

• Men \> 18 years of age;
• Histologically-proven prostate carcinoma;
• Prostate cancer clinical stage T1c
• Only one sector of the prostate demonstrating prostate cancer with no more than 1 core positive
• Gleason score \<7 ;
• Each core must range between of 10 to 50% adenocarcinoma.
• Prostate MRI must confirm area suspicious for cancer in the sector of the positive biopsy;
• Prostate specific antigen (PSA) level £ 10 ng/mL
• PORPUS, IPSS, and IIEF complete prior to procedure
• Prostate volume \< 60 cc as measured by ultra sound;
• Uroflow \>12 cc/sec with post void residual \< 100 cc.
• Life expectancy of greater than 5 years, based on co-morbidity not related to prostate cancer.

You may not qualify if:

• 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 whose has undergone radiation therapy for prostate cancer
• 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;
• Patients who are unwilling or unable to complete the patient self-assessment questionnaires;
• Myocardial infarction, transient ischemic attack or stroke, within 6 months prior to the study, Unstable or uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias
• Chronic or acute prostititis, neuroginic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
• Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days;
• All medications that cause a decrease clotting, vasoconstriction or platelet aggregation, must be stopped prior to treatment.
• History of Colon Cancer or Colon Surgery preformed
• If the patient is unable to undergo anesthesia

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G2M9, Canada

Location

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 16, 2007
• First Posted: March 19, 2007
• Study Start: March 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 15, 2012

Record last verified: 2012-06

Locations

CA (1)