NCT04086290RecruitingPhase 1/2
National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
Source: ClinicalTrials.gov · Last updated 12 Feb 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A prospective, open label phase 2 clinical trial assessing safety, complications and feasibility of radical prostatectomy (RARP) plus local stereotactic body radiotherapy (SBRT) to bone metastases in combination with short-term medical castration to a select population of prostate cancer patients with oligometastatic disease.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 2 Sept 2019
- Start date
- 10 Oct 2019
- Primary completion date
- 31 Oct 2023
- Lead sponsor
- Peter Busch Østergren
- Diseases
- Prostate cancer
- NCT number
- NCT04086290
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 10 Oct 2019 to the primary completion date, 31 Oct 2023
- 1 site 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
- Prior curative intended treatment for prostate cancer
- Prior androgen deprivation therapy (ADT)
Other illness
- History of another invasive cancer within 3 years of screening, with the exception of fully treated cancers with a remote probability of recurrence. The medical monitor and investigator must agree that the possibility of recurrence is remote for exceptions.
Other
- Eastern Cooperative Oncology Group (ECOG) Performance Status \> 1
- Evaluated not able to fulfil the study protocol.
- Contraindications against MRI
Who the study is looking for
- Age 18 years or older and willing and able to provide informed consent;
- Stage cT1 ≤ cT3b, Clinical resectable
- Gleason score ≥ 6
- M1
- ≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68Ga-PSMA PET/CT and magnetic resonance imaging (MRi)
- Absence of PSMA uptake in retroperitoneal lymph nodes, (outside the anatomical region of extended pelvic lymph node dissection as described in the European Association of Urology (EAU) guidelines.
- No visceral metastasis
- Metastases suitable for stereotactic body radiotherapy
- Non symptomatic bone lesions
- Eligible for surgery
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herlev and Gentofte Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.