Partial prostate Ablation versus Radical Treatment (PART): Comparing partial ablation of the prostate to treatment or removal of the whole prostate in men with localised cancer of one side of the prostate only
- Conditions
- Prostate cancerCancer
- Registration Number
- ISRCTN17249875
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Male
- Target Recruitment
- 800
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
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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 presence of PIRADS lesions +/- systematic biopsy, or template transperineal mapping biopsy)
7. Understanding of the English language sufficient to receive written and verbal information about the trial, its consent process and complete study questionnaires
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
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 cancer
17. Has any active implanted electronic device (e.g., pacemaker)
18. Is unable or unwilling to be catheterised
19. Has had prior or current PCa therapies
20. Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants
21. 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 staff
24. Wishing to maintain future fertility
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Previous exclusion criteria:
1. Unfit for radical treatment or general anaesthesia, or cannot tolerate transrectal ultrasound
2. Bilateral Intermediate risk disease or higher
3. 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 disease
5. Prostate volume =70 cm3 or <25 cm3
6. Previous active therapy for prostate cancer
7. History of sun hypersensitivity or photosensitive dermatitis or latex allergy
8. 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 stricture
9. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measure as of 18/11/2022: <br><br>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 <br>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, 6wks post-treatment and 3mths, 6mths, 12mths post-randomisation, thereafter every 12 months until the end of the study<br><br>_____<br><br>Previous primary outcome measure:<br><br>1. Oncological outcomes assessed by review of medical history at 3 years median follow-up post-randomisation<br>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 Outcome Measures
Name Time Method