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Trial registered on ANZCTR


Registration number
ACTRN12620000881932
Ethics application status
Approved
Date submitted
21/06/2020
Date registered
4/09/2020
Date last updated
4/09/2020
Date data sharing statement initially provided
4/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
NODE Study - Randomised Trial of Extended Pelvic Lymph Node Dissection In Patients Undergoing Robotic-Assisted Radical Prostatectomy For High-Risk Prostate Cancer
Scientific title
NODE Study - Randomised Trial of Extended Pelvic Lymph Node Dissection In Patients Undergoing Robotic-Assisted Radical Prostatectomy For High-Risk Prostate Cancer
Secondary ID [1] 301554 0
None
Universal Trial Number (UTN)
U1111-1253-7691
Trial acronym
NODE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 317958 0
Condition category
Condition code
Cancer 315993 315993 0 0
Prostate
Surgery 316233 316233 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317881 0
Treatment: Surgery
Comparator / control treatment
The control group will undergo a robotic radical prostatectomy without the lymph node dissection.
Control group
Active

Outcomes
Primary outcome [1] 324196 0
Proportion of eligible patients able to be recruited into the study.
Timepoint [1] 324196 0
From commencement of the study to final patient intervention.
Secondary outcome [1] 383987 0
Number of enrolled subjects with protocol violations
- protocol violations would be any deviation from the defined course
Examples would include:
- patients randomised to no node dissection having a node dissection
- an incomplete dissection being performed or photos not being taken adequately
- inadequate follow up
Timepoint [1] 383987 0
At any time throughout recruitment and follow up. Follow up ceases 12 months following intervention.
Secondary outcome [2] 383988 0
Adverse events
Adverse events related to:
- the lymph node dissection intraoperatively- eg vessel injury, nerve injury
- the longer length of surgery - eg pressure sore, neuropraxia
- the lymph node dissection postoperatively - eg lymphocele
Other adverse events related to surgery - eg post operative infection, thromboembolic events
These will be collected from hospital records
Timepoint [2] 383988 0
At any point from intervention to completion of follow up 12 months later.
Secondary outcome [3] 383990 0
Biochemical recurrence on PSA (prostate specific antigen) blood test
Timepoint [3] 383990 0
6 week, 3 month, 6 month and 12 months post-operatively.
Secondary outcome [4] 384010 0
Clinical recurrence - composite secondary outcome
Symptomatic recurrence
Radiological evidence of localised recurrence or distant metastases.
- determined by the presence of cancer in the prostate bed or elsewhere on abdominal/pelvic computed tomography (CT) scan, bone scintigraphy, MRI or prostate-specific membrane antigen (PSMA)-PET
Timepoint [4] 384010 0
Any point in the 12 months following the procedure
Secondary outcome [5] 384011 0
Survival
Timepoint [5] 384011 0
Date of death or alive at 12 months following procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- History of deep venous thrombosis
- History of lower limb lymphoedema
- History of previous pelvic radiotherapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation by contacting central randomisation off site at ANZUP Cancer trials group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Unstratified blocked randomisation using computer generated random number table
Blocks of 4
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2020
Actual
Date of last participant enrolment
Anticipated
14/09/2021
Actual
Date of last data collection
Anticipated
14/09/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16958 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 16959 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 30617 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 305988 0
Hospital
Name [1] 305988 0
Chris O'Brien Lifehouse Hospital
Country [1] 305988 0
Australia
Funding source category [2] 306017 0
Hospital
Name [2] 306017 0
Royal Prince Alfred Hospital
Country [2] 306017 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse Hospital
Address
119-143 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 306449 0
Hospital
Name [1] 306449 0
Royal Prince Alfred Hospital
Address [1] 306449 0
50 Missenden Rd, Camperdown NSW 2050
Country [1] 306449 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306227 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 306227 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 306227 0
Australia
Date submitted for ethics approval [1] 306227 0
07/04/2019
Approval date [1] 306227 0
25/02/2020
Ethics approval number [1] 306227 0
2019/ETH09765

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103166 0
Prof Henry Woo
Address 103166 0
Lifehouse Hospital
119-143 Missenden Rd, Camperdown NSW 2050
Country 103166 0
Australia
Phone 103166 0
+61 02 90527586
Fax 103166 0
Email 103166 0
[email protected]
Contact person for public queries
Name 103167 0
George McClintock
Address 103167 0
Lifehouse Hospital
119-143 Missenden Rd, Camperdown NSW 2050
Country 103167 0
Australia
Phone 103167 0
+61 1300852500
Fax 103167 0
Email 103167 0
[email protected]
Contact person for scientific queries
Name 103168 0
George McClintock
Address 103168 0
Lifehouse Hospital
119-143 Missenden Rd, Camperdown NSW 2050
Country 103168 0
Australia
Phone 103168 0
+61 1300852500
Fax 103168 0
Email 103168 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.