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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 March 2023 |
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Main ID: |
NCT02971358 |
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Date of registration:
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20/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer
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Scientific title:
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Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer - a Prospective Single Center Phase I/II Study |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02971358 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Austria
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Contacts
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Name:
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Bernhard Grubmüller, MD |
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Address:
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Telephone:
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004314040026150 |
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Email:
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bernhard.grubmueller@meduniwien.ac.at |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adenocarcinoma of the prostate
- Very high risk PCA (PSA = 20 oder Gleason Score = 8 oder = cT3) and/or
oligometastasierte PCA (T any N positive M any, oder T any N any M positive)
- =5 bone metastasis
- =75 years
- Ability for informed consent
- Clinically no infiltration into the rectum or pelvic wall
- Clinically no visceral metastasis
- Male, >18 Jahre
- Fit for surgery
- ECOG Performance Status 0 oder 1
Exclusion Criteria:
- Male, < 18 Jahre
- > 5 bone metastasis
- > 75 years
- No ability for informed consent
- Clinically infiltration into the rectum or pelvic wall
- Not fit for surgery
- Clinically visceral metastasis
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Locally Advanced and Metastatic Prostate Cancer
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Intervention(s)
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Procedure: Radical prostatectomy
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Primary Outcome(s)
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The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification)
[Time Frame: 90]
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Secondary Outcome(s)
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Time to start androgen deprivation therapy
[Time Frame: 2 years]
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Secondary ID(s)
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1461/2016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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