National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
Key facts
- Where
- Herlev, DenmarkSee the site
- Phase
- Phase 1/2
Where in Denmark
- Herlev and Gentofte HospitalHerlev, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peter Busch Østergren
- Trial code
- NCT04086290
- Record updated
- 12 February 2020
- Original description
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.Read full original descriptionShow less
Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
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.
Inclusion: 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.
Exclusion: Prior curative intended treatment for prostate cancer; Prior androgen deprivation therapy (ADT); 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; Eastern Cooperative Oncology Group (ECOG) Performance Status > 1; Evaluated not able to fulfil the study protocol; Contraindications against MRI.