Condition category
Cancer
Date applied
01/10/2014
Date assigned
06/10/2014
Last edited
30/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Miss Steffi le Conte

ORCID ID

Contact details

Surgical Intervention Trials Unit (SITU)
University of Oxford
Botnar Research Centre
Nuffield Orthopaedic Centre
Old Road
Headington
Oxford
OX3 7LD
United Kingdom
+44 (0)1865 737961
part@nds.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 12/35/54

Study information

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

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

South Central - Berkshire, 22/12/2014

Study design

Prospective multi-centre parallel-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2015

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

80

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

31/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Churchill Hospital
Oxford
OX3 7LE
United Kingdom

Trial participating centre

Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom

Trial participating centre

Basingstoke & North Hampshire Hospitals
Basingstoke
RG24 9NA
United Kingdom

Trial participating centre

Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Trial participating centre

University College Hospital
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
-
heather.house@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

01/01/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.