Prostate cancer Cancer Malignant neoplasm of the prostate
Conditions
Interventions
There are three groups:
1. Open prostatectomy
2. Laparoscopic prostatectomy
3. Robot-assisted prostatectomy
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Prostate cancer patient that has chosen radical prostatectomy as treatment (with or without lymphadenectomy) 2. Clinical stage T1, T2a, T2b or T2c, N0 M0 3. Gleason score less than or equal to 7 4. Prostate-specific antigen (PSA) less than or equal to 20 5. Aged greater than or equal to 18 years, male 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Patient medically unfit for surgery 2. Prior pelvic radiotherapy or rectal excisional surgery 3. Positive bone scan or evidence of nodal metastases on magnetic resonance imaging (MRI) or computed tomography (CT) 4. Clinical stage T3 5. Neoadjuvant hormone therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accrual rate: aim to recruit more than 100 patients with at least 75 patients within a 12-month period (e.g. between 12 and 24 months after all centres are open to recruitment). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Compliance with protocol: a compliant patient will be defined as one who receives their allocated treatment and the in-patient standardised peri-operative care. We aim to show that more than 80% are compliant. 2. Clinical and patient-orientated outcomes: 2.1. Operation duration 2.2. Blood loss 2.3. Transfusion rates 2.4. Peri-operative haemoglobin change 2.5. Operative complications 2.6. Length of hospital stay 2.7. Pathological specimen positive margin rates and biochemical progression-free rates 2.8. Sexual function 2.9. Urinary continence 2.10. Quality of life measures All patients are followed up for 12 months. | — |
Countries
England, United Kingdom
Outcome results
None listed