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

  • STATUS
    Recruiting
  • End date
    Dec 20, 2027
  • participants needed
    200
  • sponsor
    Medical University of Vienna
Updated on 20 April 2022

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.

Details
Condition Locally Advanced and Metastatic Prostate Cancer
Treatment Radical Prostatectomy
Clinical Study IdentifierNCT02971358
SponsorMedical University of Vienna
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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