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

RecruitingNAAges 18 Years - 75 YearsMaleMedical University of Vienna
NCT02971358 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Radical prostatectomy
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Where

1 site
Medical University of Vienna
Vienna, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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