Clinical trial NCT00805883: MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy
Official title: MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Neoplasm
Keywords: Prostate Neoplasm
Localized
Photothermal
Radical Prostatectomy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-12-10
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Validity of MR/US Fusion and MR Targeting
timeFrame: 7 Days after Focal Therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: John Trachtenberg, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.