Local treatment for newly diagnosed metastatic prostate cancer
Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).
This study tests if surgery to remove the prostate can help men with newly diagnosed metastatic prostate cancer do better than sticking with standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Male |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 5 sites (Aalst and 4 other locations) |
| Trial ID | NCT02138721 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of radical prostatectomy as a local treatment option for patients recently diagnosed with metastatic hormone-sensitive prostate cancer. Eligible patients will undergo a multidisciplinary evaluation and can choose to receive radical prostatectomy with pelvic lymph-node dissection or continue with standard care. Follow-up will include routine visits and imaging to monitor disease progression. The study aims to gather data on the outcomes of local treatment compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with newly diagnosed metastatic prostate adenocarcinoma and a life expectancy of at least two years.
Not a fit: Patients with previous treatments for prostate cancer or those with severe metastatic complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival and quality of life for patients with metastatic prostate cancer.
How similar studies have performed: While local treatment approaches for metastatic prostate cancer are being explored, this specific intervention is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of prostate adenocarcinoma, confirmed by histology * Newly diagnosis of metastatic disease (stage TanyNanyM+) * Life expectancy ≥2y based on comorbid conditions, WHO performance status 0-2 * Written informed consent, male ≥18yo * Willing and expected to comply with study protocol and follow-up schedule * Multidisciplinary Oncologic Consultation (MOC) approval Exclusion Criteria: * Previous local or systemic treatment for prostate cancer * Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression * Symptoms clearly related to metastatic lesions * Any other previous or current (malignant) disease which, in the judgment of the responsible physician, is likely to interfere with LoMP treatment or assessment
Where this trial is running
Aalst and 4 other locations
- ASZ Aalst — Aalst, Belgium (Recruiting)
- Imelda Ziekenhuis — Bonheiden, Belgium (Recruiting)
- University Hospital, Ghent — Ghent, Belgium (Recruiting)
- Sint-Fransiskusziekenhuis — Heusden-Zolder, Belgium (Recruiting)
- AZ Jan Portaels — Vilvoorde, Belgium (Recruiting)
Study contacts
- Principal investigator: Nicolaas Lumen, MD, PhD — University Hospital, Ghent
- Study coordinator: Nicolaas Lumen, MD, PhD
- Email: nicolaas.lumen@uzgent.be
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.