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 measure
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
03/08/2018
Reason abandoned (if study stopped)
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
18/04/2018
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
Funders
Funder type
Charity
Funder name
Prostate Cancer Foundation
Alternative name(s)
THE PROSTATE CANCER FOUNDATION, PCF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
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
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN15704862_PROTOCOL_V3.0_30Oct2017.pdf Uploaded 30/11/2017