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Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02971358
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Bernhard Grubmüller, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE November 20, 2016
First Posted Date  ICMJE November 22, 2016
Last Update Posted Date April 5, 2022
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2016)
The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification) [ Time Frame: 90 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2016)
Time to start androgen deprivation therapy [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced and Metastatic Prostate Cancer
Intervention  ICMJE Procedure: Radical prostatectomy
Standard radical prostatectomy with extended lymph node dissection is performed.
Study Arms  ICMJE 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.
Intervention: Procedure: Radical prostatectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2022)
200
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2016)
50
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02971358
Other Study ID Numbers  ICMJE 1461/2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Dr. Bernhard Grubmüller, Medical University of Vienna
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medical University of Vienna
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP