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Clinical Trials/ACTRN12623000902695
ACTRN12623000902695
Recruiting
未知

MRI Guided Stereotactic Focal Ablation of Prostate Cancer investigating feasibility, Toxicity and Patient Reported Outcomes.

Austin Health0 sites25 target enrollmentAugust 22, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Austin Health
Enrollment
25
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 22, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
Male

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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