- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02971358
Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer
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
Prostate cancer is the most common non-skin cancer diagnosed among men and the second leading cause of male cancer deaths in the United States. In 2013, it is estimated that 29,270 men have died from prostate cancer. Although radiation and surgery are quite effective for localized disease, there is no effective cure for men who present with metastatic prostate cancer as the 5-year relative survival rate is only 28%.
Currently, androgen deprivation therapy (ADT) via medical or surgical castration is the standard first-line therapy in men with metastatic disease but castration-recurrent prostate cancer (CRPC) eventually emerges with a median time of 18-24 months. Once CRPC develops, secondary hormonal manipulation, chemotherapy, and immunotherapy are marginally effective.
Given the dismal prognosis of metastatic prostate cancer, new ideas and novel approaches must be explored to improve the clinical outcome. In this regard, recently emerging data suggest that local tumor control may enhance the effectiveness of subsequent systemic therapies. Therefore, in this proposal, the investigators have designed a Phase I/II study in which they will prospectively evaluate the safety and feasibility of cytoreductive prostatectomy in men with newly diagnosed mPCa.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- Recruiting
- Medical University of Vienna
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Contact:
- Bernhard Grubmüller, MD
- Phone Number: 004314040026150
- Email: bernhard.grubmueller@meduniwien.ac.at
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radical prostatectomy arm
In this arm the investigators will include patients with locally advanced or metastatic prostate cancer, who will undergo cytoreductive radical prostatectomy with extended lymph node dissection.
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Standard radical prostatectomy with extended lymph node dissection is performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification)
Time Frame: 90
|
90
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to start androgen deprivation therapy
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1461/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Radical prostatectomy
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-
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-
Hospices Civils de LyonCompleted
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University of MichiganCompleted
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Rio de Janeiro State UniversityCompletedProstatic Cancer | Prostatic NeoplasmBrazil
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IRCCS San RaffaeleActive, not recruiting
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VA Office of Research and DevelopmentNational Cancer Institute (NCI); Agency for Healthcare Research and Quality...Completed
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Swiss Group for Clinical Cancer ResearchTerminated