Partial prostate Ablation versus Radical prosTatectomy | Not Recruiting
Partial prostate Ablation versus Ra... | Not Recruiting
Partial prostate Ablation versus Radical prosTatectomy
PART

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Medical Conditions
  • Prostate cancer
Primary Contact Details
Miss Steffi le Conte
+44 (0)1865 737961
See all trial contact details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN99760303
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Research Details
  • 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
Phase
Sorry, this information is not available
Study Design
Prospective multi-centre parallel-group randomised controlled trial
Study Type
Interventional
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 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)
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Male
Age Range
Adult
Who Can Participate
Patient
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)
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
Sheffield
S10 2JF
Southampton General Hospital
Southampton
England
SO16 6YD
Basingstoke
RG24 9NA
Royal Free Hospital
London
NW1 2BU
Churchill Hospital
Oxford
OX3 7LE
Trial Contact(s)
Primary Trial Contact
Miss Steffi le Conte
+44 (0)1865 737961
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Health Technology Assessment Programme
Other Study ID Numbers
HTA 12/35/54
Sponsor(s)
University of Oxford (UK)
Key Dates

Recruitment Start Date

01 Jan 2015

Recruitment End Date

31 Jan 2017

Trial Start Date

01 Jan 2015

Trial End Date

31 Mar 2017

Date added to source

06 Oct 2014

Date updated in source

30 Sep 2016