Partial prostate Ablation versus Radical prosTatectomy
- Conditions
- Prostate cancerCancer
- Registration Number
- ISRCTN99760303
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30264692 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 80
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
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 <35ml/min
14. Unable to give consent to participate in the trial as judged by the attending clinicians
Previous exclusion criteria:
1. Unfit for radical surgery as assessed by Consultant Anaesthetist
2. Significant bilateral disease
3. Low risk disease [Gleason score 6 or less, PSA 10ng/ml or less, less than 4mm total cancer on biopsy]
4. High risk disease [Gleason score 8 or greater, PSA >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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measures as of 20/09/2016:<br>1. Randomisation of 80 participants within the proposed timelines<br>2. Uptake of randomisation of 50% among eligible and invited patients<br><br>Previous primary outcome measures:<br>1. Randomisation of 100 participants within the proposed timelines<br>2. Uptake of randomisation of 50% among eligible and invited patients
- Secondary Outcome Measures
Name Time Method Added 07/03/2016:<br>Findings of the Qualitative Recruitment Investigation (QRI)