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

Not Applicable

Completed

• Conditions: ewly diagnosed oligometastatic prostate cancer (1-3 skeletal lesions; no visceral lesions); Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN15704862
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-05
• Study Completion: 2018-08-03
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 18/10/2017:<br>Feasibility to randomise, measured at 3 months<br><br>Previous primary outcome measures:<br>Feasibility to randomise, measured at 6 months

Secondary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 18/10/2017:<br>1. Quality of life, measured by the EQ5D5L questionnaire at baseline and 3 months<br>2. Time to castrate resistance, assessed by PSA measurements at 3 months and then ongoing as routine NHS follow-up care schedules<br><br>Previous secondary outcome measures:<br>1. Quality of life, measured by the EQ5D5L questionnaire at baseline, 6 weeks, 3 months and 6 months<br>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