Prostate Cancer Clinical Trial
Official title:
Randomized Study To Study the Effect of Lung Protective Ventilation (PEEP) Compared With Normal Ventilation (ZEEP) on Lung Function, Kidney Treatment of Sodium and Water, Vasoactive Hormones, Biomarkers of Nephrotoxicity and Haemodynamics in Patients Undergoing Robot-assisted Radical Prostatectomy
Randomized study investigating the effects of lung protective ventilation (PEEP), as compared with normal ventilation (ZEEP) on lung function, treatment of the renal sodium and water, vasoactive hormones, biomarkers of nephrotoxicity, and the circulation of patients undergoing assisted robotic radical prostatectomy
Protocol Summary
Purpose:
The project will investigate whether a suspected lung protective ventilator therapy in
connection with surgery for cancer of the prostate (prostate) have a relevant beneficial
effects on lung function, renal function and circulation associated with keyhole surgery
performed with surgical robot.
Trial method:
The trial is a randomized study (randomized controlled trials), which are drawn between
normal and a suspected lung protective ventilator treatment in connection with the surgical
removal of the prostate due to Cancers. Before the operation, collected urine and blood
samples and that a study of lung function and circulation as a starting point. During the
operation, and in the following two days collected urine and blood samples. Prepare
Furthermore, new studies of lung function and circulation. Blood tests and lung function
studied also in outpatient control about 1 week after surgery.
The two groups of patients (for respectively normal respiratory therapy and suspected lung
protective) compared subsequent terms. Impact on lung function, renal function and
circulation as well as the number and severity of any complications compared to assess
whether the suspected lung protective ventilator therapy is safe and provides adequate
beneficial effect to introduce as standard in the future.
Tissue sampling used in the form of blood tests or urine tests MHP research biobank in the
experiment. This tissue will be used for analyzes in the specific project and the tissue will
be destroyed after current guidelines for project completion.
Side effects and risks:
There are at every blood sampling a small risk of infection and bleeding. Using standard
sterile technique. Blood volume removed by blood tests is max of 250 ml in total. Removing
this amount of blood does not entail health risks in patients. There may be discomfort around
the injection site, the needle drop is wrong in the arm, but using standard sterile technique
and dropped down by experienced personnel. Blood samples for the experiment performed during
routine blood sampling equipment as specified in the department's instructions.
For lung studies will in some cases could be detected a certain constriction of the small
branches of the airways (bronchi). To determine whether this is a condition may require
treatment given ally a spray to suck, which aims to expand the branches in order to improve
lung function. This medication can cause slight transient dizziness and palpitations.
Disadvantages:
The additional lung examinations in the study will attempt established in connection with the
patient's usual attendance and stay at the hospital to avoid extra visits. There must be
calculated some extra time spent for outpatient visits in connection with participation in
the trial. There is no economic disadvantages associated with the trial for the patient.
Economic conditions:
There is no economic disadvantages associated with the trial for the patient. Funding for the
project will be done through a joint financing by the Urology Department D, Department of
Anesthesiology and University Clinic for Kidney disease and high blood pressure, Hospital
West and Aarhus University. Research funds will be sought from public and private funds.
Publication of trial results:
The results, both positive and negative findings, will be made published in internationally
recognized scientific journal anonymously with no personally identifiable data.
Research Ethics statement:
The project reported to the Ethical Science Council at the Central Denmark Region. Database
for the project must be approved by the Data Protection Agency by Region of Central. The
project is started only after the approval of these two bodies. The project will comply with
applicable GCP rules.
Recruitment of participants:
First contacting the patient about the project via the operator, Urology Department, at the
information interview on operation. If the patient wants to get further information about the
project handed out written information and project manager contacted.
The written information consists of: Participant Information, consent form, "Information for
subjects" and "Your Rights as a test subject in a biomedical research." The patient is
informed both in writing and orally on the right and the opportunity to bring legal counsel
to informed consent.
The project manager or his representative hold subsequent information interview about 7 days
before surgery. This will last approximately 30 minutes. Information being conducted in
consultation room at the clinic, where there is no other activity in the allocated room
during the interview.
The anesthesia controller or his deputy hold right now usual anesthesia monitoring and
ensuring written consent.
At the oral information, patients will be informed that there is a request to participate in
a biomedical research. Patients are informed acc. the guidelines in "Guidelines for review,
etc. of a biomedical research for the ethics committee system "from the Central Scientific
Ethical Committee. Information is provided for the experiment, as listed in Annex 1
"Information for volunteers." The subjects, who wish to participate are advised that, if they
wish, can get consideration before submitting their written consent to participate in
research is voluntary, and that they will always be able to draw a committed participation
back .
The subjects were informed that they will receive information on the results achieved by
research reporting on the project if they are interested in this.
Written informed consent given to the project manager or the anesthetic consultant or his
deputy in the project in connection with the information interview, journal recording and
anesthesia monitoring. The subjects signed concent- and proxy statement, which is kept by the
Data Protection Agency guidelines. A copy provided to the subject.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |