Evaluating surgery for high-risk prostate cancer
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
Run by Medical University of Vienna · NCT02971358 · Data updated 2026-11-12
This study is testing if surgery can help men with very high-risk prostate cancer do better than with standard treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | Men only |
| Enrollment | 200 (estimated) |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Vienna) |
| Status | Recruiting |
| Started | August 2016 |
| Main results expected | December 2028 |
| Study ends | December 2030 |
| Registry record updated | May 14, 2025 |
| Trial ID | NCT02971358 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 18 to 75 with very high-risk prostate cancer and limited bone metastasis.
✕Probably not a fit
Patients with more than five bone metastases or visceral metastasis are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Medical University of Vienna
Vienna, Austria Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.