Testing radical prostatectomy in men with oligometastatic prostate cancer that has spread to the bone

ISRCTN	ISRCTN15704862
DOI	https://doi.org/10.1186/ISRCTN15704862
Protocol serial number	N/A
Sponsor	University of Oxford (UK)
Funder	Prostate Cancer Foundation

Submission date: 20/01/2016
Registration date: 05/02/2016
Last edited: 11/01/2023

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-surgery-for-men-with-prostate-cancer-that-has-spread-to

Contact information

Dr Prasanna Sooriakumaran
Scientific

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

Study information

Primary study design	Interventional
Study design	Interventional multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Testing Radical prostatectomy in men with prostate cancer and oligoMetastases to the bone (TRoMbone): a randomised controlled feasibility trial
Study acronym	TRoMbone
Study objectives	It is feasible to randomise men with oligometastatic prostate cancer between treatment-as-usual and treatment-as-usual plus radical prostatectomy.
Ethics approval(s)	Oxford Research Ethics Committee, 14/09/2016, ref: 16/SC/0376
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	03/08/2018

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Male
Target sample size at registration	50
Key inclusion criteria	Men under 75 years old with locally resectable, oligometastatic prostate cancer, and fit for radical prostatectomy
Key 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
Date of first enrolment	19/05/2017
Date of final enrolment	18/04/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Oxford University Hospitals

OX3 7LE
United Kingdom

University College London Hospitals

W1G 8PH
United Kingdom

Royal Surrey County Hospital

GU2 7XX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version V3.0	30/10/2017	30/11/2017	No	No

Additional files

ISRCTN15704862_PROTOCOL_V3.0_30Oct2017.pdf: Uploaded 30/11/2017

Editorial Notes

11/01/2023: Cancer Research UK plain English summary link added to plain English summary field.
05/02/2019: The overall end date has been changed from 20/11/2018 to 03/08/2018.
03/05/2018: The recruitment end date has been changed from 20/08/2018 to 18/04/2018.
30/11/2017: Uploaded protocol Version 3.0 30 Oct 2017 (not peer reviewed).
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.