NCT03655886CompletedPhase 2
Cytoreductive Prostatectomy Versus Cytoreductive Prostate Irradiation As a Local Treatment Option for Metastatic Prostate Cancer: a Multicentric Feasibility Trial
Source: ClinicalTrials.gov · Last updated 21 Mar 2025
Brief summary (registry, in English)
According to the guidelines of the European Association of Urology (EAU), the first-line treatment for newly diagnosed mPC consists of immediate castration with the addition of docetaxel or abiraterone acetate. As seen in other well-known solid tumours - such as ovarian, colon and renal cancer - local treatment (LT) of the primary tumour could lead to a survival benefit compared to standard of care (SOC). Several retrospective studies have suggested a survival benefit of local treatment of the primary tumour with SOC versus SOC only in mPC. These patients also have less local symptoms of their disease, which has a major impact on quality of life (QoL). Several prospective studies have already been set up to compare either surgery or radiotherapy with the SOC. In expectation of their results and because randomization seems challenging, the investigators want to set up a trial to evaluate the feasibility of randomization between both local treatment groups.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 26 Jul 2018
- Start date
- 15 Aug 2018
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- University Hospital, Ghent
- Diseases
- Prostate cancer
- NCT number
- NCT03655886
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 43
- From 15 Aug 2018 to the primary completion date, 31 Dec 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous systemic treatment for PC except ADT started within 3 months before randomization
- Previous radiotherapy to the pelvis interfering with prostate irradiation
- Previous surgery in the pelvis interfering with radical prostatectomy
- Previous or current malignant disease which is likely to interfere with LoMP II treatment or assessment
Other illness
- Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
- Psychological disorder intervening with understanding the information or the informed consent
Other
- Symptoms related to metastatic lesions, persisting for at least 2 weeks after initiation of ADT
Who the study is looking for
- Male ≥18y
- Histologically proven PC
- Newly diagnosed metastatic PC as assessed by standard imaging (CT and bone scintigraphy) or PSMA PET-CT
- ECOG 0-1 (2 if related to local PC symptoms)
- Eligible for local treatment
- Written informed consent and able and willing to comply with protocol requirements
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Sint Jan Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| AZ Maria Middelares Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| AZ Jan Palfijn Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| University Hospital Ghent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Leuven University hospital Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.