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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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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Locally Advanced and Metastatic Prostate Cancer Procedure: Radical prostatectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2016
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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.
 Procedure: Radical prostatectomy
Standard radical prostatectomy with extended lymph node dissection is performed.


Outcome Measures
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Primary Outcome Measures :
  1. The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification) [ Time Frame: 90 ]

Secondary Outcome Measures :
  1. Time to start androgen deprivation therapy [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971358


Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Bernhard Grubmüller, MD    004314040026150    bernhard.grubmueller@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
More Information
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Responsible Party: Dr. Bernhard Grubmüller, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02971358    
Other Study ID Numbers: 1461/2016
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases