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Clinical Trials/NCT02971358
NCT02971358
Recruiting
Not Applicable

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

Medical University of Vienna1 site in 1 country200 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Locally Advanced and Metastatic Prostate Cancer
Sponsor
Medical University of Vienna
Enrollment
200
Locations
1
Primary Endpoint
The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification)
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
December 2030
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Bernhard Grubmüller

MD

Medical University of Vienna

Eligibility 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

Outcomes

Primary Outcomes

The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification)

Time Frame: 90

Secondary Outcomes

  • Time to start androgen deprivation therapy(2 years)

Study Sites (1)

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