Condition category
Cancer
Date applied
20/01/2016
Date assigned
05/02/2016
Last edited
18/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Prasanna Sooriakumaran

ORCID ID

Contact details

Nuffield Department of Surgical Sciences
University of Oxford
Old Road Campus Research Building
Old Road
Headington
Oxford
OX3 7DQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Testing Radical prostatectomy in men with prostate cancer and oligoMetastases to the bone (TRoMbone): a randomised controlled feasibility trial

Acronym

TRoMbone

Study hypothesis

It is feasible to randomise men with oligometastatic prostate cancer between treatment-as-usual and treatment-as-usual plus radical prostatectomy.

Ethics approval

Oxford Research Ethics Committee, 14/09/2016, ref: 16/SC/0376

Study design

Interventional multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled 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

Newly diagnosed oligometastatic prostate cancer (1-3 skeletal lesions; no visceral lesions)

Intervention

Current interventions as of 11/05/2017:
1. Radical prostatectomy (including extended pelvic lymphadenectomy) plus standard care
2. Standard care
The total duration of follow-up is 3 months in both arms and then they revert to standard NHS follow-up care

Previous interventions:
1. Radical prostatectomy (including extended pelvic lymphadenectomy) plus treatment-as-usual (androgen deprivation therapy)
2. Treatment-as-usual (androgen deprivation therapy)
The total duration of follow-up is 6 months in both arms and then they revert to standard NHS follow-up care.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Current secondary outcome measures as of 18/10/2017:
Feasibility to randomise, measured at 3 months

Previous primary outcome measures:
Feasibility to randomise, measured at 6 months

Secondary outcome measures

Current primary outcome measures as of 18/10/2017:
1. Quality of life, measured by the EQ5D5L questionnaire at baseline and 3 months
2. Time to castrate resistance, assessed by PSA measurements at 3 months and then ongoing as routine NHS follow-up care schedules

Previous secondary outcome measures:
1. Quality of life, measured by the EQ5D5L questionnaire at baseline, 6 weeks, 3 months and 6 months
2. Time to castrate resistance, assessed by PSA measurements at 6 weeks, 3 months, 6 months, and then ongoing as routine NHS follow-up care schedules

Overall trial start date

20/02/2017

Overall trial end date

20/11/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Men under 75 years old with locally resectable, oligometastatic prostate cancer, and fit for radical prostatectomy

Participant type

Patient

Age group

Mixed

Gender

Male

Target number of participants

50

Participant exclusion criteria

Current exclusion criteria as of 18/10/2017:
1. Contraindications to radical prostatectomy
2. Visceral metastases
3. Prior radiotherapy to the abdomen/pelvis or to skeletal metastases
4. Any systemic therapy of prostate cancer (including standard care) for 12 or more months
5. Participation in another prostate cancer clinical trial

Previous exclusion criteria:
1. Contraindications to radical prostatectomy
2. Visceral metastases
3. Prior radiotherapy to the abdomen/pelvis or to skeletal metastases
4. Any systemic therapy of prostate cancer (including treatment-as-usual) for 3 or more months
5. Participation in another prostate cancer clinical trial

Recruitment start date

19/05/2017

Recruitment end date

20/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospitals
OX3 7LE
United Kingdom

Trial participating centre

University College London Hospitals
W1G 8PH
United Kingdom

Trial participating centre

Royal Surrey County Hospital
GU2 7XX
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Oxford
Oxford
OX3 7DQ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Prostate Cancer Foundation

Alternative name(s)

PCF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a repository and not made available as they will form the basis for a further large randomized controlled trial.

Intention to publish date

20/11/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/10/2017: The overall trial dates have been updated from 01/01/2016-01/04/2017 to 20/02/2017-20/11/2018. The recruitment start date has been updated from 20/02/2017-20/02/2018 to 19/05/2017-20/08/2018. The intention to publish date has been updated from 01/04/2018 to 20/11/2018. 26/07/2017: Ethics approval details added. 08/06/2017: Cancer Help UK lay summary link added to plain English summary field 06/06/2017: Internal review 11/05/2017: The following changes were made to the trial record: 1. The recruitment start date was changed from 01/07/2016 to 20/02/2017. 2. The recruitment end date was changed from 31/12/2016 to 20/02/2018.