MRI Guided Stereotactic Focal Ablation of Prostate Cancer

Not Applicable

Recruiting

Conditions: Prostate Cancer
Cancer - Prostate

Registration Number: ACTRN12623000902695

Lead Sponsor: Austin Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 25

Inclusion Criteria

Age 40yrs or older; WHO performance status 0-2; Life expectancy at least 10 years; biopsy proven adenocarcinoma of the prostate; low or favourable intermediate risk prostate cancer; PSA less than 20 ng/mL ; Gleason score 7; Clinical T stage cT1c - cT2c. Solitary Tumours not more than 20mm in diameter on MRI; Tumour margins visible on MRI; Prostate Volume less than 100cc on TRUS; willing and able to give written informed consent

Exclusion Criteria

Inability to undergo MRI scanning due to presence of metal or pacemaker or other reason; Clinical Lymph node or distant metastases; Previous treatment for prostate cancer; Previous pelvic radiation therapy; Medications that can affect PSA in the previous 3 months; individuals who are unable to tolerate prolonged stationary supine position up to 1 hour; Urethral stricture; Inflammatory bowel disease; Invasive malignancy within the last 5 years apart from non melanomatous skin cancer; Patients with baseline impotence scoring 17 or below in the SHIM questionnaire; PAtients with Incontinence demonstrated by ICQC-SF score of greater than 5; Active Urinary tract infection and or prostatitis; Prior Trans urethral resection of the prostate within 6 weeks before Radiation therapy; Current participation in another Clinical Investigation; Inability to meet Organs at risk dose constraints

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment delivery is feasible based on whether each fraction can be delivered within 80 minutes on the treatment table. The feasibility will be assess by measuring the time is takes to deliver the treatment[ The primary time point is when the fraction is being delivered. ];Patient reported change in EPIC-26 bowel domain[ at 24 months and 60 months post Radiation therapy]; Biochemical free survival defined as recurrence PSA nadir+2( Which is the Phoenix definition for biochemical recurrence) PSA is determined by a blood test. [ PSA will be measured at baseline and then every 3 months until 1 year after treatment then every 6 months until 5 years after treatment ]

Secondary Outcome Measures