Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer
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
About This Trial
- This study is testing whether surgically removing the prostate gland is safe and beneficial for men with advanced or high-risk prostate cancer.
- It is designed for men aged 75 or younger who are newly diagnosed and whose cancer has spread to only a few areas, such as up to five spots in the bones or nearby lymph nodes.
- To be eligible, you must be in good overall health, fit enough for major surgery, and have no cancer spread to internal organs.
- Before considering this trial, you should know that surgery is not typically the standard treatment once cancer has spread, but researchers want to see if removing the main tumor improves long-term health outcomes.
More Information
- 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.
Who Can Enroll
- Age Range: 18 - 75 years
- Gender: Male
- Who This Trial is For: This study is testing whether surgically removing the prostate gland is safe and beneficial for men with advanced or high-risk prostate cancer.
Study Details
- Start Date: August 2016
- Lead Sponsor: Medical University of Vienna
Full Eligibility Criteria
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, 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
Treatments
- Procedure: Radical prostatectomy