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


Condition: Locally Advanced and Metastatic Prostate Cancer

Intervention:

  • Procedure: Radical prostatectomy

Purpose: 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 Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02971358

Sponsor: Medical University of Vienna

Primary Outcome Measures:

  • Measure: The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification)
  • Time Frame: 90
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Time to start androgen deprivation therapy
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 50

Study Start Date: August 2016

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: Male

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

Location:

  • Medical University of Vienna
  • Vienna 1090 Austria

View trial on ClinicalTrials.gov


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