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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Roxanne
Williams
+44 01865 737961
part-trial@nds.ox.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Prostate cancer
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Background and study aims
The PART study aims to test whether treating only the part of the prostate containing the prostate cancer is as effective in curing prostate cancer as treating the whole prostate gland, and has fewer side effects. Treatment of the whole prostate gland (known as ‘radical’ treatment) includes surgical removal, radiotherapy, or brachytherapy (known as ‘radical’ treatments).
Prostate cancer is the most common cancer in men in the UK. Treatment of the whole prostate (‘radical’ treatment) is normally offered, even if the cancer is only on one side of the prostate gland. New technologies can now treat the part of the prostate affected by the cancer only (known as ‘partial ablation’, or PA), destroying the cancer but preserving urinary and sexual functions. PA shows promising results in terms of having minimal side effects in men with low-risk prostate cancer, compared to a policy of ‘active surveillance’ (i.e. no active treatment). We want to test PA in men with intermediate-risk localised prostate cancer, who would usually be advised to have radical treatment.
The two types of PA in this trial will be Irreversible Electroporation (IRE) and High Intensity Focal Ultrasound (HIFU). IRE is an image-guided tissue ablation technology that induces cell death via short, strong pulsed electric fields. Due to its non-thermal nature, IRE preserves vessels, nerves and extracellular matrix, making it an effective treatment modality for prostate cancer. HIFU uses ultrasound energy focused by an acoustic lens to cause tissue damage as a result of thermal coagulative necrosis and acoustic cavitation. HIFU is available in a number of centres in the UK and is approved by the NHS as a treatment for pancreatic and liver cancer.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
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 qu
You may not be able to take part if:
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 days3. Unfit for radical treatment or general anaesthesia or cannot tolerate transrectal ultrasound4. In the opinion of the treating physician, has a contraindication to either HIFU or IRE5. Not suitable for mpMRI or have a single or bilateral hip replacement6. Has evidence of extraprostatic extension by mpMRI, or clinical or radiological ≥T3 disease7. Concomitant cancer or previous active treatment for PCa8. Evidence of metastatic disease9. Bilateral intermediate risk disease or higher10. Low-risk (Gleason Grade Group 1) disease only, or high-risk (Grade Group ≥4) PCa only11. History of acute urinary retention within the last 6 months prior to entry to the study12. 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 anaesthetic15. Has a history of bladder neck contracture16. Had active treatment for a malignancy within 3 years, including malignant melanoma, except other types of skin cancer17. Has any active implanted electronic device (e.g., pacemaker)18. Is unable or unwilling to be catheterised19. Has had prior or current PCa therapies20. Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants21. Has had prior major rectal surgery (except haemorrhoids)22. Is actively bleeding, is anticoagulated or on blood thinning medications that cannot be stopped for the peri-operative period for a PA procedure, or has a significant bleeding disorder that may affect the peri-operative period as judged by the clinical staff.23. Unable to give consent to participate in the study as judged by the clinical staff24. Wishing to maintain future fertility
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Previous exclusion criteria:
1. Unfit for radical treatment or general anaesthesia, or cannot tolerate transrectal ultrasound2. Bilateral Intermediate risk disease or higher3. Low-risk disease (Grade Group 1, PSA ≤10 ng/ml, <4 mm total cancer on biopsy) or high-risk disease (Grade Group ≥4, PSA >20 ng/ml, ≥T2c stage)4. Clinical T3 prostate cancer (i.e. extra-capsular prostate cancer) on digital rectal examination or mpMRI, or evidence of metastatic disease5. Prostate volume ≥70 cm3 or <25 cm36. Previous active therapy for prostate cancer7. History of sun hypersensitivity or photosensitive dermatitis or latex allergy8. History of acute urinary retention within 6 months of study entry or who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms, or with metal implants/stents in the urethra, or with a history of a urethral stricture9. Conditions requiring medication with potential photosensitizing effects (tetracyclines, quinolones, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin, and amiodarone), if these treatments could not be stopped at least 10 days before and for 3 days after the partial ablation procedure or replaced by treatments without photosensitizing properties10. Anticoagulant drugs (e.g., warfarin) that could not be withdrawn during the 10 days prior to the partial ablation procedure or antiplatelet drugs (e.g. aspirin) that could not be withdrawn during the 10 days prior to the partial ablation procedure and 3 days after the partial ablation procedure11. Prostatic calcification and cysts that interfere with the effective delivery of partial ablation12. Renal impairment and/or a Glomerular Filtration Rate (GFR) <35 ml/min13. Men unable to give consent to participate in the trial as judged by the clinical staff
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Roxanne
Williams
+44 01865 737961
part-trial@nds.ox.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Oxford and funded by National Institute for Health and Care Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
