Localised prostate carcinoma Cancer Prostate cancer
Conditions
Interventions
Stage 1: verification that men with unilateral cancer, as demonstrated by TRUS-guided biopsies, have true unilateral disease. Although initially it was mooted that we could rely on just the TRUS biop
Sponsors
University College London Hospitals (UCLH) NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion criteria for verification stage 1 1. Men aged under 80 years 2. Histological diagnosis of prostate adenocarcinoma 3. Cancer prostate-confined only 4. Cancer confined to one lobe as defined by TRUS biopsy 5. Serum PSA less than or equal to 15 ng/ml 6. A life expectancy of five years or more 7. Prostate volume less than or equal to 40 cc 8. Signed informed consent form by patient for multi-sequence MRI and transperineal biopsy 9. Patient willing to proceed to stage 2 if stage 2 inclusion/exclusion criteria fulfilled Stage 2 HIFU hemi-ablation treatment inclusion criteria: 1. Men with unilateral prostate adenocarcinoma after having undergone verification of unilateral disease in stage 1 of this trial or verification (with ms-MRI and transperineal template biopsies outside of this trial) 2. The following inclusion criteria for stage 1 are to be re-assessed after stage 1: 1, 2, 3, 6, 7 3. Signed informed consent by patient for HIFU hemiablation treatment
Exclusion criteria
Exclusion criteria: Exclusion criteria for verification stage 1: 1. Men who have received androgen suppression within previous six months 2. Men who have had previous radiation therapy for prostate cancer 3. Men treated with chemotherapy for prostate cancer 4. Men with evidence of metastatic disease 5. Men with latex allergies 6. Men who have undergone prior significant rectal surgery preventing insertion of transrectal probe 7. Men with intraprostatic calcifications greater than or equal to 10 mm in size 8. Men who have undergone previous transurethral resection of the prostate or laser prostatectomy 9. Men who have undergone previous HIFU, cryosurgery, thermal or microwave therapy to the prostate 10. American Society of Anaesthesiology grades III - IV 11. Men not fit for general anaesthesia or regional anaesthesia as assessed by consultant anaesthetist 12. Men unable to have MRI scanning (e.g. severe claustrophobia, permanent cardiac pacemaker, metallic implant likely to contribute significant artefact to images) Exclusion criteria for treatment stage 2: 1. All exclusion criteria for stage 2 are to be verified again before treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine feasibility, patient acceptability and side-effect profile of using Sonablate® 500 HIFU to hemiablate the prostate gland in localised, unilateral prostate cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the effectiveness of therapy by assessing cancer control in the following ways: 1. Biochemical (PSA) progression-free survival 2. Proportion of men with negative biopsies post-treatment | — |
Countries
United Kingdom
Outcome results
None listed