Locally Advanced and Metastatic Prostate Cancer Clinical Trial
Official title:
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
| NCT number | NCT02971358 |
| Other study ID # | 1461/2016 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2016 |
| Est. completion date | December 2027 |
| Verified date | March 2023 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | December 2027 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 75 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification) | 90 | ||
| Secondary | Time to start androgen deprivation therapy | 2 years |