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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15704862

Enrollment

Registered

2016-02-05

Start date

2017-05-19

Completion date

Unknown

Last updated

2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed oligometastatic prostate cancer (1-3 skeletal lesions

Interventions

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 arm

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026