National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
NCT04086290 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2020-02-12
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 combination with short-term medical castration to a select population of prostate cancer patients with oligometastatic disease.
Conditions
- Prostate Cancer Metastatic
Interventions
- PROCEDURE
-
RARP
Radical prostatectomy + extended pelvic lymph node dissection
- RADIATION
-
SBRT
Stereotactic body radiotherapy to osseous lesions
- DRUG
-
ADT
six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
Sponsors & Collaborators
-
Peter Busch Østergren
lead OTHER
Principal Investigators
-
Peter B Østergren, MD · Herlev and Gentofte Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-10
- Primary Completion
- 2023-10-31
- Completion
- 2028-10-31
Countries
- Denmark
Study Locations
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