Actively Recruiting
Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer
Led by Medical University of Vienna · Updated on 2025-05-14
200
Participants Needed
1
Research Sites
747 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 to 75 years
- Diagnosed with adenocarcinoma of the prostate
- Very high risk prostate cancer (PSA ≥ 20 or Gleason Score ≥ 8 or tumor stage ≥ cT3) and/or oligometastatic prostate cancer (any T stage, N positive, any M stage, or any T, any N, M positive)
- Five or fewer bone metastases
- Able to provide informed consent
- No clinical infiltration into the rectum or pelvic wall
- No clinical visceral metastasis
- Fit for surgery
- ECOG Performance Status of 0 or 1
You will not qualify if you...
- Male younger than 18 years
- More than 5 bone metastases
- Older than 75 years
- Unable to provide informed consent
- Clinical infiltration into the rectum or pelvic wall
- Not fit for surgery
- Clinical visceral metastasis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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