None listed
Conditions
Brief summary
The purpose of this pilot study is to determine whether it is possible to recruit sufficient participants in a trial investigating the role of extended pelvic lymph node dissection in addition to the removal of the prostate gland for the treatment of prostate cancer. Who is it for? You may be eligible for this study if you are an adult with prostate cancer who has already been scheduled for robotic assisted radical prostatectomy. Study details Participants in this study will receive one of two treatments: 1. Removal of the prostate gland, or 2. Removal of the prostate gland plus removal of pelvic lymph nodes Both surgeries will be completed using robotic assistance, as is the standard of care. The treatment the participant will receive will be decided randomly. All participants will be followed up for 12 months for recurrences of cancer, side effects and overall survival. Following the procedure, you would be required to undergo regular blood tests, and possibly radiological scans to monitor for cancer recurrence. It is hoped that this research will determine if a larger trial can be completed on extended lymph node dissection, and that the larger trial will help determine if extended lymph node dissection is beneficial over a radical prostatectomy.
Interventions
The intervention will be the performance of an extended pelvic lymph node dissection (ePLND). This procedure is performed during surgery for prostate cancer - specifically during a robotic radical prostatectomy, the current standard of care. Currently the procedure is performed variably by different urologists. Current guidelines recommend it being performed only in high risk patients. The procedure involves removal of many of the lymph nodes in the pelvis, and if cancer has spread to the lymph nodes, may help to remove all the cancer. To ensure consistency of surgery, surgeons will be required to take photos of the areas from which they have removed the lymph nodes to ensure enough has been taken out. The intervention will be performed by 3 experienced consultant urologists at the Chris O'Brien Lifehouse Hospital and Royal Prince Alfred Hospital. As a pilot, 20 patients will be recruited, this is to ensure that recruitment for a larger trial is possible and to ensure that adherence to the protocol by the surgeons is possible. The ePLND is expected to approximately 1 hour to the procedure, which currently takes 2-4 hours. Specific training is not required to perform the ePLND, though these surgeons have significant experience performing it. One of the researcher team will be present at all of the cases to monitor for protocol violations, after the pilot study recruitment is completed all patients will have a chart review, review of intraoperative images and initial data to assess for protocol violations.
Sponsors
Study design
Eligibility
Inclusion criteria
Histologically proven prostate cancer scheduled for robotic assisted radical prostatectomy Non-metastatic, high risk or very high risk disease, defined as one or more of: - Stage >T3a - A histological grading on biopsy of ISUP Grade Group 4 (Gleason 4+4=8) or higher, - Prostate specific antigen (PSA) >20ng/ml Prostate-specific membrane antigen (PSMA)-PET negative for metastatic disease The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
Exclusion criteria
- History of deep venous thrombosis - History of lower limb lymphoedema - History of previous pelvic radiotherapy