Prostate cancer Cancer
Conditions
Interventions
Current interventions:
Participants will be randomised 1:1 to receive either Partial Ablation (PA) treatment or Radical Treatment (RT). Randomisation is done using a randomisation programme provided
Sponsors
University of Oxford
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 27/01/2026: 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, or with a midline intermediate-risk Gleason grade group 2 or 3 (3+4 or 4+3) PCa amenable to a PA treatment 2. PSA = 20 ng/ml within the last 120 days 3. Pre- biopsy bpMRI or mpMRI, of adequate diagnostic quality as determined at the PART PA Planning Meeting, within the previous 6 months, and bilateral biopsies of the prostate (transrectal or transperineal, and targeted biopsy for visible lesions) 4. Clinically =T2c intermediate-risk Gleason grade group 2 or 3 (3+4 or 4+3) disease judged by results of digital rectal examination, imaging by MRI and biopsy (low-risk Gleason grade group 1 lesions on the contralateral side are acceptable; a midline single focus of clinically significant Gleason grade group 2 or 3 disease, if deemed suitable for PA, is also 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 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 1.2. And/or >4 mm cancer core length in any one core irrespective of Grade Group 1.3. PSA =20 ng/ml 1.4. Clinically =T2b disease judged by results of digital rectal examination and imaging by mpMRI 2. Prostate volume <70 cm3 and =25 cm3 3. Fit, eligible with standard of care recommendation for RP, RRT or LDR-B 4. Life expectancy of =10 years 5. No concomitant cancer and no previous active treatment for prostate cancer 6. Pre-biopsy mpMRI scan and biopsy (transrectal targeted guided by pres
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 27/01/2026: 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 120 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 MRI or have a single or bilateral hip replacement 6. Has evidence of extraprostatic extension by MRI, or clinical or radiological =T3 disease 7. Concomitant cancer or previous active treatment for PCa 8. Evidence of metastatic disease 9. Bilateral foci of intermediate risk disease or higher 10. Low-risk (Gleason Grade Group 1) disease only, or high-risk (Grade Group =4) PCa only 11. History of spontaneous unprecipitated acute urinary retention within the last 6 months prior to entry to the study (a precipitated acute urinary retention episode, for example, secondary to previous prostate biopsy or urinary tract infection, is acceptable) 12. Prostatic calcification and cysts causing ultrasonic shadowing or greater than 1cm 13. History (within 3 years) of inflammatory bowel disease or any condition that may increase the risk of recto-urethral fistula formation 14. Has known hypersensitivity to pancuronium bromide, atracurium or cistracurium, or any medical condition such that muscle relaxation cannot be administered as part of a general anaesthetic 15. Has a history of bladder neck contracture 16. Had active treatment for a malignancy within 3 years, including malignant melanoma, except other types of skin cancer 17. Has any active implanted electronic device incompatible with either MRI or IRE (e.g. pacemaker) (N.B. some newer devices may be compatible with MRI and/or IRE – if compatible, that is acceptable) _____ Previous 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 10. Low-risk (Gleason Grade Group 1) disease only, or high-risk (Grade Group =4) PCa only 11. History of acute urinary retention within the last 6 months prior to entry to the study 12. Prostatic calcification and cysts causing ultrasonic shadowing or greater than 1cm (for HIFU) 13. History (within 3 years) of inflammatory bowel disease or any condition that may increase the risk of recto-urethral fistula formation (for HIFU) 14. Has known hypersensitivity to pancuronium bromide, atracurium or cistracurium, or any medical condition such that muscle relaxation cannot be administered as part of a general anaesthetic 15. Has a history of bladder neck contracture 16. Had active treatment for a malignancy within 3 years, including malignant melanoma, except other types of skin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 10/03/2026: 1. Primary treatment success determined by oncological outcomes assessed by review of medical history at a minimum of 3 years median follow-up post-treatment, with at least 12 months post-treatment follow-up of the last recruited participant _____ Previous primary outcome measure as of 18/11/2022: 1. Primary treatment failure determined by oncological outcomes assessed by review of medical history at a minimum of 3 years median follow-up post-randomisation, with at least 12 months post-randomisation follow-up of the last recruited participant 2. Side effect profile and patient-reported outcomes profile measured using Health-Related Quality of Life (HRQoL) as measured by the Patient Oriented Prostate Utility Scale (PORPUS-P) at baseline, 6 weeks post-treatment and 3, 6, 12 months post-randomisation, thereafter every 12 months until the end of the study _____ Previous primary outcome measure: 1. Oncological outcomes assessed by review of medical history at 3 years median follow-up post-randomisation 2. Side effects profile and patient-reported outcomes assessed by review of medical history and questionnaires at 3 years median follow-up post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 10/03/2026: 1. Side effect profile and patient-reported outcomes profile measured using Health-Related Quality of Life (HRQoL) as measured by the Patient Oriented Prostate Utility Scale (PORPUS-P) at baseline, 6 weeks post-treatment and 3, 6, 9, 12, 15, 18 and 24 months post-randomisation, thereafter every 12 months until the end of the study 2. HRQoL measured using standard, validated patient-reported outcome measures (PROMs) questionnaires: International Prostate Symptom Score (IPSS), EQ-5D-5L, Expanded Prostate Cancer Index Composite (EPIC) and Memorial Anxiety Scale for Prostate Cancer (MAX-PC) (modified 18-item) at baseline, 6 weeks post-treatment and 3, 6, 9, 12, 15, 18 and 24 months post-randomisation, thereafter every 12 months until the end of the study 3. Health care resource utilisation and cost-effectiveness in terms of cost per quality-adjusted life year (QALY) at baseline, and 3, 6, 9, 12, 15, 18 and 24 months post-randomisation, thereafter every 12 months until the end of the study 4. Short, medium and long-term serious adverse events related to treatments recorded at 31 days and 3 years 5. Proportion of patients needing repeat PA treatment in the PA group measured using documentation of the need for repeat PA treatment in the PA group at 1-year post-treatment and 3 years post-treatment (for those that reach this time point in the study’s lifetime) 6. Accuracy of current mpMRI/bpMRI imaging and biopsy protocols in determining suitability of patients for PA measured by the proportion of prostatectomy patients who have high-risk disease or bilateral/multifocal intermediate disease after histopathological evaluation (only in men who have had RP, including salvage RP) 7. Time to disease progression (including local and distal recurrence) at a minimum 12 months post-treatment follow-up of the last treated participant, but will be longer for those recruited and treated earlier in the study 8. Time to disease-specifi | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactJo Cook
Outcome results
None listed