Status:
RECRUITING
National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
Lead Sponsor:
Peter Busch Østergren
Conditions:
Prostate Cancer Metastatic
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Eligibility Criteria
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
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04086290
Start Date
October 10 2019
End Date
October 1 2028
Last Update
February 12 2020
Active Locations (1)
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1
Herlev and Gentofte Hospital
Herlev, Denmark, 2730