Biopsy-proven clinically localised high-risk prostate cancer Cancer
Conditions
Interventions
Participants will be identified through screening in local and regional specialist multi-disciplinary teams. Adult males with biopsy-proven clinically localised high-risk PCa, where the local multi-di
Sponsors
Cardiff and Vale University Health Board
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 months 2. Complete excision of the primary prostate tumour measured using the surgical margins after surgery 3. Metastasis-free survival measured using imaging from routine follow-up 4. Health-related quality of life measured using EPIC 26 and EQ-5D-5L questionnaires at baseline, and 3, 12, 18, 24 and 36 months 5. Time to return to normal activities measured using a questionnaire at 3 months 6. Indirect costs due to productivity losses measured using a questionnaire at 12, 24 and 26 months 7. Costs to participants measured using a questionnaire at 12, 24 and 36 months | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactMaria;Seonaidh Ntessalen;Cotton
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Outcome results
None listed