Focal Laser treatment for localised Prostate Cancer.Pilot study to evaluate the safety and effectiveness with ProFocal -Rx

Not Applicable

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12618001774213
• Lead Sponsor: Medlogical Innovations Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-29
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

•Male, 50 years of age or older.
•Diagnosis of prostate adenocarcinoma. ( intermediate risk )
•PSA <20
•Clinical stage T2c or less
•Gleason score of 7 or less.
•One, two, or three tumor suspicious regions identified on multiparametric MRI
•Negative radiographic indication of extra­capsular extent.
•A documented Karnofsky performance status of at least 70.
•Estimated survival of 5 years or greater, as determined by treating physician. •Tolerance for anesthesia/sedation.
•Ability to give informed consent.

Exclusion Criteria

•Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
•Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater.
•History of other significant primary non­skin malignancy within previous three years.
•Patients with renal insufficiency with an estimated glomerular filtration (EGF) < = 30 are excluded, as they will not be able to undergo gadolinium enhance MRI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified