RecruitingPhase 1Phase 2NCT04086290

National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients

Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients


Sponsor

Peter Busch Østergren

Enrollment

20 participants

Start Date

Oct 10, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Danish study tests a combined approach for prostate cancer patients who have a small number of bone metastases (cancer that has spread to the bones). Instead of just treating the prostate, the study adds a precise radiation technique (called SBRT — stereotactic body radiotherapy) to also target the metastatic spots, along with surgical removal of the prostate. **You may be eligible if...** - You are 18 or older - You have prostate cancer that has spread to no more than 3 bones (in the spine, pelvis, or limb bones) - The cancer has NOT spread to lymph nodes outside the pelvis or to organs - Your metastases are suitable for SBRT and are not causing symptoms - You are fit enough for surgery **You may NOT be eligible if...** - You have had any prior treatment for prostate cancer - You have been on hormone therapy (ADT) before - You have had another cancer in the past 3 years - Your overall health is poor (ECOG performance status above 1) - You cannot have an MRI scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERARP

Radical prostatectomy + extended pelvic lymph node dissection

RADIATIONSBRT

Stereotactic body radiotherapy to osseous lesions

DRUGADT

six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.


Locations(1)

Herlev and Gentofte Hospital

Herlev, Denmark

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NCT04086290


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