Evaluation of the role of Lymphadenectomy In high-risk Prostate cancer SurgEry

Not Applicable

• Conditions: Biopsy-proven clinically localised high-risk prostate cancer; Cancer

• Registration Number: ISRCTN14434966
• Lead Sponsor: Cardiff and Vale University Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-06
• Last Update Posted: 19 August 2024
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 1080

Inclusion Criteria

1. Adults =18 years
2. Biopsy-proven clinically localised high-risk PCa
3. Local multi-disciplinary review identifying those cases thought be suitable for RP; with negative staging imaging (as per local standard of care)
4. Able and willing to give informed consent to participate and to participate in study procedures

Exclusion Criteria

1. Hormone therapy within the 3 months prior to consent
2. Previous radical treatment for PCa (radical treatment includes radical prostatectomy and/or radiotherapy and/or focal therapy [eg cryotherapy or HIFU])
3. Unsuitable for surgical treatment
4. People without capacity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cancer recurrence, defined as prostate-specific antigen (PSA) recurrence/persistence with two consecutive measures =0.2ng/ml and/or disease progression (eg metastatic disease) and/or need for further prostate cancer treatment and/or prostate cancer-specific death and is assessed over 3 years.2. Economic outcome measured as incremental cost per QALY gained at 3 years

Secondary Outcome Measures

Name	Time	Method
1. Harms (complications and re-intervention rates) measured using CLASSIntra during surgery, the Comprehensive Complications Index at 3 months, from medical records up to 3 years, and questionnaires at 12, 24 and 36 months2. Complete excision of the primary prostate tumour measured using the surgical margins after surgery 3. Metastasis-free survival measured using imaging from routine follow-up4. Health-related quality of life measured using EPIC 26 and EQ-5D-5L questionnaires at baseline, and 3, 12, 18, 24 and 36 months5. Time to return to normal activities measured using a questionnaire at 3 months6. Indirect costs due to productivity losses measured using a questionnaire at 12, 24 and 26 months7. Costs to participants measured using a questionnaire at 12, 24 and 36 months