Partial prostate Ablation versus Radical prosTatectomy

ISRCTN	ISRCTN99760303
DOI	https://doi.org/10.1186/ISRCTN99760303
Secondary identifying numbers	HTA 12/35/54

Submission date: 01/10/2014
Registration date: 06/10/2014
Last edited: 11/05/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-high-intensity-focused-ultrasound-or-surgery-treat-prostate-cancer-contained-one-part-prostate-gland-part

Study website

Contact information

Miss Steffi le Conte
Scientific

Surgical Intervention Trials Unit (SITU)
University of Oxford
Botnar Research Centre
Nuffield Orthopaedic Centre
Old Road
Headington
Oxford
OX3 7LD
United Kingdom

Phone	+44 (0)1865 737961
Email	part@nds.ox.ac.uk

Study information

Study design	Prospective multi-centre parallel-group randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A randomised controlled trial of Partial prostate Ablation versus Radical prosTatectomy (PART) in intermediate risk unilateral clinically localised prostate cancer - a feasibility study
Study acronym	PART
Study hypothesis	The findings of an HTA systematic review 10/136/01: Ablative therapy for men with localised prostate cancer, which is due to publish shortly, conclude that the role of focal therapies in the management of men with localised prostate cancer should be investigated. It may be desirable to incorporate the focal approach into a multicentre RCT, with long-term follow-up and would include predefined assessment of cancer specific, dysfunction and health-related quality of life measures. Our hypothesis is that a significant proportion of these patients would benefit from focal therapy with minimally invasive rather than radical procedures, with less morbidity, improved QoL, and reduced cost without compromising treatment effectiveness. If this can be established, ablative procedures could eventually replace conventional radical treatments in suitable patients and reduce the burden of treating the disease for the patients and the NHS. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/123554
Ethics approval(s)	South Central - Berkshire, 22/12/2014
Condition	Prostate cancer
Intervention	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 days 2. Follow up in the clinic at six weeks post-surgery as per routine NHS care. This will include a PSA blood test and the following quesitonnaires will be presented to the patient:- 2.1. IIEF-15 Questionnaire 2.2. IPSS Questionnaire 2.3. UCLA-EPIC urinary continence and Bowel Questionnaire 2.4. EQ-5D-5L 2.5. FACT-P Version 4 2.6. The Modified 18-term Memorial Anxiety Scale for Prostate Cancer 2.7. Resource Utilisation Questionnaire 3. Followed up in the clinic every three months post-surgery in the first year and then every 6 months as per routine NHS care. PSA blood tests will be carried out every 3 months of 2 years. The following questionnaires will be presented to them at 3, 6, 9, 12, 18, 24, 30 and 36 months follow-up: 3.1. IIEF-15 Questionnaire 3.2. IPSS Questionnaire 3.3. UCLA-EPIC urinary continence and Bowel Questionnaire 3.4. EQ-5D-5L 3.5. FACT-P Version 4 3.6. The Modified 18-term Memorial Anxiety Scale for Prostate Cancer 3.7. Resource Utilisation Questionnaire If at any point disease progression is suspected (rising PSA ≥0.2) the patient will be restaged. In patients randomised to PA: 1. Routine removal of catheter at 7 days 2. Study specific care includes an mpMRI at two weeks 3. Followed up routinely at six weeks post-surgery as per routine NHS care. This will include a PSA blood test and the following questionniares will be presented to the patient:- 3.1. IIEF-15 Questionnaire 3.2. IPSS Questionnaire 3.3. UCLA-EPIC urinary continence and Bowel Questionnaire 3.4. EQ-5D-5L 3.5. FACT-P Version 4 3.6. The Modified 18-term Memorial Anxiety Scale for Prostate Cancer 3.7. Resource Utilisation Questionnaire 4. Followed up in the clinic every three months post-surgery for the first year and then every 6 months as per routine NHS care. PSA blood tests will be carried out every 3 months of 2 years. The following questionnaires will be presented to them at 3, 6, 9, 12, 18, 24, 30 and 36 months follow-up: 4.1. IIEF-15 Questionnaire 4.2. IPSS Questionnaire 4.3. UCLA-EPIC urinary continence and Bowel Questionnaire 4.4. EQ-5D-5L 4.5. FACT-P Version 4 4.6. The Modified 18-term Memorial Anxiety Scale for Prostate Cancer 4.7. Resource Utilisation Questionnaire 5. Study specific care includes an mpMRI at twelve months 6. Study specific care includes transrectal biopsies at twelve months 7. Study specific care includes an mpMRI at three years 8. Study specific care includes transrectal biopsies at three years
Intervention type	Procedure/Surgery
Primary outcome measure	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 outcome measures	Added 07/03/2016: Findings of the Qualitative Recruitment Investigation (QRI)
Overall study start date	01/01/2015
Overall study end date	01/01/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	80
Participant 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
Participant 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 <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)
Recruitment start date	01/01/2015
Recruitment end date	31/03/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Churchill Hospital

Oxford
OX3 7LE
United Kingdom

Royal Hallamshire Hospital

Sheffield
S10 2JF
United Kingdom

Basingstoke & North Hampshire Hospitals

Basingstoke
RG24 9NA
United Kingdom

Southampton General Hospital

Southampton
SO16 6YD
United Kingdom

University College Hospital

London
NW1 2BU
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
England
United Kingdom

Email	heather.house@admin.ox.ac.uk
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date	01/01/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	To be confirmed at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2018		Yes	No
Plain English results			11/05/2023	No	Yes

Editorial Notes

11/05/2023: Link to plain English results added.
01/10/2018: Publication reference added.
09/04/2018: The recruitment end date was changed from 31/01/2017 to 31/03/2017 and the overall study end date was changed from 31/03/2017 to 01/01/2020.
30/09/2016: the recruitment end date was changed from 31/03/2017 to 31/01/2017.
22/09/2016: the recruitment end date was changed from 30/04/2016 to 31/03/2017.
20/09/2016: the following changes were made to the trial record:
1. The overall trial end date was changed from 01/01/2018 to 31/03/2017.
2. The target number of participants was changed from 100 to 80.