Condition category
Cancer
Date applied
20/01/2016
Date assigned
05/02/2016
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organization

Trial website

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– submission pending, plan to submit in March 2016

Study design

Interventional randomised controlled trial; multi-centre

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 below to request a patient information sheet

Condition

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

Intervention

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

Feasibility to randomise, measured at 6 months

Secondary outcome measures

1. Quality of life as 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

01/01/2016

Overall trial end date

01/04/2017

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

Adult

Gender

Male

Target number of participants

50

Participant 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

01/07/2016

Recruitment end date

31/12/2016

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. The data will be stored in a repository and not be made available as it will form the basis for a further large randomized controlled trial. We have funding for this feasibility trial only currently, but if we demonstrate success of feasibility then we will use the results to apply for a full trial.

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review.