Evaluating surgery for high-risk 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
This study is testing if surgery can help men with very high-risk prostate cancer do better than with standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Vienna) |
| Trial ID | NCT02971358 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and early efficacy of radical prostatectomy in men diagnosed with very high-risk locally advanced and oligometastatic prostate cancer. The study aims to explore whether local tumor control through surgery can improve outcomes for patients who typically have a poor prognosis with standard treatments. Participants will undergo radical prostatectomy, and their outcomes will be monitored to assess the effectiveness of this approach compared to traditional therapies. The trial seeks to provide new insights into treatment options for advanced prostate cancer.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 75 with very high-risk prostate cancer and limited bone metastasis.
Not a fit: Patients with more than five bone metastases or visceral metastasis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new treatment option that improves survival rates for men with advanced prostate cancer.
How similar studies have performed: While there is emerging data on local tumor control in advanced prostate cancer, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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, \< 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
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.