ISRCTN17249875
Active, Not Recruiting
N/A
A randomised controlled trial of Partial prostate Ablation versus Radical Treatment (PART) in intermediate risk, unilateral clinically localised prostate cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate cancer
- Sponsor
- niversity of Oxford
- Enrollment
- 800
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 18/11/2022:
- •1\. Age \=18 years with unilateral clinically significant intermediate\-risk Gleason Grade Group 2 or 3 (3\+4 or 4\+3\) PCa, or dominant unilateral clinically significant intermediate\-risk PCa and contralateral low\-risk low\-volume Gleason Grade Group 1 (3\+3\) PCa:
- •2\. PSA \= 20 ng/ml within the last 90 days
- •3\. Pre\-biopsy mpMRI scan and bilateral biopsies of the prostate (transrectal or transperineal, and targeted biopsy for visible lesions)
- •4\. Clinically \=T2b disease judged by results of digital rectal examination, imaging by Multi\-parametric Magnetic Resonance Imaging (mpMRI) and biopsy (low\-risk Gleason Grade Group 1 lesions on the contralateral side are acceptable)
- •5\. Fit, eligible with a standard of care recommendation for any or all of radical prostatectomy, radical radiotherapy or low dose\-rate brachytherapy (LDR\-B), and suitable for PA using at least one of irreversible electroporation (IRE) or high intensity focused ultrasound (HIFU)
- •6\. An understanding of the English language sufficient to receive written and verbal information about the study, its consent process and complete study questionnaires
- •Previous inclusion criteria:
- •1\. Unilateral clinically significant intermediate\-risk prostate cancer, or dominant unilateral clinically significant intermediate\-risk prostate cancer and small contralateral low\-risk low\-volume prostate cancer:
- •1\.1\. Grade Group 2 or 3 (Gleason Grade 3\+4 or 4\+3\) disease
Exclusion Criteria
- •Current exclusion criteria as of 18/11/2022:
- •1\. Taking part in another therapeutic PCa clinical trial or has been involved in such trials within the previous 4 months (N.B. the TRANSLATE trial is a diagnostic trial and co\-enrolment is permitted)
- •2\. PSA \> 20 ng/ml within the last 90 days
- •3\. Unfit for radical treatment or general anaesthesia or cannot tolerate transrectal ultrasound
- •4\. In the opinion of the treating physician, has a contraindication to either HIFU or IRE
- •5\. Not suitable for mpMRI or have a single or bilateral hip replacement
- •6\. Has evidence of extraprostatic extension by mpMRI, or clinical or radiological \=T3 disease
- •7\. Concomitant cancer or previous active treatment for PCa
- •8\. Evidence of metastatic disease
- •9\. Bilateral intermediate risk disease or higher
Outcomes
Primary Outcomes
Not specified
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