Prostate cancer Cancer
Conditions
Interventions
Partial Ablation (PA) versus Radical prostatectomy (RP). Randomization is on a 1:1 basis and follow-up will be over 3 years:
In patients randomised to RP:
1. Routine removal of catheter at 10-14 day
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 11/02/2016: 1. Men with unilateral clinically significant intermediate risk prostate cancer or dominant unilateral clinically significant intermediate risk & small contralateral low-risk disease: 1.1. Gleason grade score 7 (3+4 or 4+3) 1.2. High volume Gleason grade score 6 (> 4mm cancer core length) 1.3. PSA = 20 ng/ml 1.4. Clinical = T2b disease 2. Life expectancy of =10 years 3. Fit, eligible and normally destined for radical surgery 4. No concomitant cancer 5. No previous treatment of their prostate cancer 6. An understanding of the English language sufficient to understand written and verbal information about the trial, its consent process and the study questionnaires Previous inclusion criteria: 1. Men with unilateral clinically significant intermediate risk prostate cancer: 1.1. Gleason grade score 7 (3+4 or 4+3) 1.2. And/or > 4mm cancer core length 1.3. PSA = 20 ng/ml 1.4. - = T2b disease 2. Fit and eligible for radical surgery 3. No concomitant cancer 4. No previous treatment of their prostate cancer
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 11/02/2016: 1. Unfit for radical surgery 2. Significant bilateral disease 3. Low risk disease [Gleason score 6 or less, PSA 10ng/ml] 4. High risk disease [Gleason score 8 or greater, PSA >20ng/ml] 5. Clinical T3 disease 6. Men who have received previous active therapy for prostate cancer 7. Men with evidence of extra prostate disease 8. Men with an inability to tolerate a transrectal ultrasound 9. Men with latex allergy 10. Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. 11. Metal implants/stents in the urethra 12. Prostatic calcification and cysts which interfere with effective delivery of HIFU 13. Men with renal impairment and a GFR 20ng/ml, T2c stage or higher] 5. Men who have had previous radiation therapy 6. Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer 7. Men who have had previous HIFU, cryosurgery, thermal or microwave therapy to the prostate. 8. Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging 9. Men with an inability to tolerate a transrectal ultrasound or men with latex allergies as the HIFU probe is covered with a latex condom sheath prior to insertion into the back passage 10. Men who have undergone prior significant rectal surgery preventing insertion of trans-rectal HIFU probe (decided on the type of surgery in individual cases) 11. Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP. 12. Presence of metal implants/stents in the urethra 13. Presence of prostatic calcification and cysts (on transrectal ultrasound) whose location will interfere with effective delivery of HIFU therapy 14. Men with renal impairment with a GFR of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI) 15. Unable to provide informed consent (eg because of cognitive impairment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 20/09/2016: 1. Randomisation of 80 participants within the proposed timelines 2. Uptake of randomisation of 50% among eligible and invited patients Previous primary outcome measures: 1. Randomisation of 100 participants within the proposed timelines 2. Uptake of randomisation of 50% among eligible and invited patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 07/03/2016: Findings of the Qualitative Recruitment Investigation (QRI) | — |
Countries
England, United Kingdom
Outcome results
None listed