Testing radical prostatectomy in men with oligometastatic prostate cancer that has spread to the bone
| ISRCTN | ISRCTN15704862 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15704862 |
| Secondary identifying numbers | N/A |
- 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
Plain English Summary
Contact information
Scientific
Nuffield Department of Surgical Sciences
University of Oxford
Old Road Campus Research Building
Old Road
Headington
Oxford
OX3 7DQ
United Kingdom
Study information
| Study design | Interventional multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 hypothesis | 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 |
| 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 |
| 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 study start date | 20/02/2017 |
| Overall study end date | 03/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Male |
| Target number of participants | 50 |
| Participant inclusion criteria | Men under 75 years old with locally resectable, oligometastatic prostate cancer, and fit for radical prostatectomy |
| 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
- England
- United Kingdom
Study participating centres
United Kingdom
United Kingdom
United Kingdom
Sponsor information
University/education
Oxford
Oxford
OX3 7DQ
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- CaP CURE, PCF
- Location
- United States of America
Results and Publications
| Intention to publish date | 20/11/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| 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? |
|---|---|---|---|---|---|
| Protocol file | version V3.0 | 30/10/2017 | 30/11/2017 | No | No |
| HRA research summary | 28/06/2023 | 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.
