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CompletedNCT00805883Updated May 27, 2011

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

A Phase 1 interventional study of Focal Phothtermal Ablation in Prostate Neoplasm, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-05-27.

Sponsored by University Health Network, Toronto · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
40 Years to 80 Years
Sex
Male
01

Study 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.

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Conditions studied

  • Prostate Neoplasm

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Keywords

  • Prostate Neoplasm
  • Localized
  • Photothermal
  • Radical Prostatectomy
03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's planned enrollment of 10 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Browse University Health Network, Toronto studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    1

    Procedure: Focal Phothtermal Ablation

Interventions

  • ProcedureFocal Phothtermal Ablation

    Under general anasthesia and in Lithotomy position 2-4 14 Fr laser fibers will be placed into the prostate using 3D US guidance.

06

What researchers measure

Primary outcomes

  1. Validity of MR/US Fusion and MR Targeting

    Time frame: 7 Days after Focal Therapy

07

Study locations

1 site
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
08

References and documents

Publications

  • 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. PubMed 20346578 ↗

Related links

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2009, a primary completion of Jun 2010 and a completion of Jun 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2008
First posted
Dec 10, 2008
Start
Feb 2009
Primary completionActual
Jun 2010
CompletionActual
Jun 2010
Last update
May 27, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00805883
Lead sponsor
University Health Network, Toronto
First posted
Dec 10, 2008
Start date
Feb 2009
Primary completion
Jun 2010
Completion
Jun 2010
Last update
May 27, 2011

Study contacts

John Trachtenberg, M.D
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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