None listed
Conditions
Brief summary
The purpose of this study is to evaluate the feasibility of a new laser therapy system (called ProFocal-Rx Laser Therapy System) for the treatment of certain prostate cancers. Who is it for? You may be eligible for this study if you are aged 50 or older and have a diagnosis of prostate cancer. Study details All participants in this study will undergo a general anaesthetic and targeted treatment (called ‘ablation’) of their prostate cancer in an outpatient setting. Immediate following the procedure, an MRI scan will be performed to determine the extent of the laser ablation. Six weeks after the procedure participants will have a targeted biopsy of the prostate to assess the outcome of the laser therapy. It is hoped this research will demonstrate the feasibility of this technology to treat prostate tumours, reduce discomfort and improve patients quality of life.
Interventions
In this study, we propose to evaluate the feasibility of a novel, thermal therapy and feedback system (ProFocalRx Laser Thermal Therapy System) for the treatment of biopsy confirmed and MR visible prostate cancers. The system’s realtime measurement system provides information on the thermal dose delivered to the target, resulting in a more precise and controlled delivery which has not been possible to date with other ablative therapies.
MR / US guided focal laser ablation will be performed u
In this study, we propose to evaluate the feasibility of a novel, thermal therapy and feedback system (ProFocalRx Laser Thermal Therapy System) for the treatment of biopsy confirmed and MR visible prostate cancers. The system’s realtime measurement system provides information on the thermal dose delivered to the target, resulting in a more precise and controlled delivery which has not been possible to date with other ablative therapies. MR / US guided focal laser ablation will be performed using the ProFocal-Rx Thermal Therapy System. The treatment require a general anaesthetic and approximate treatment time of under 1 hour. The Urologist will be performing the treatment. This system comprises a surgical diode laser, a fiberoptic laser applicator with diffusing tip and temperature feedback monitoring system.Focal targeted laser therapy for treating localised prostate cancer in men. The actual lasering of the tumour will take 10-20 minutes. Men 50 years and older who have been diagnosed with a positive MRI and intermediate risk prostate cancer will be eligible. They will undergo a general anaesthetic and MRI - US fusion targeted treatment of their prostate cancer in an outpatient setting. Immediate post treatment MRI will determine the extent of the laser ablation and a follow up targeted biopsy of the prostate in 6 weeks will confirm the success of the outcome of focal laser therapy.
Sponsors
Medlogical Innovations Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Outcome results
None listed