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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer Metastatic

Intervention / Treatment
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* Procedure: RARP
* Radiation: SBRT
* Drug: ADT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RARP + SBRT + ADT<br>Radical prostatectomy + extended pelvic lymph node dissection according to EAU guidelines followed by stereotactic body radiotherapy to osseous lesions with six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist. | Procedure: RARP<br>* Radical prostatectomy + extended pelvic lymph node dissection<br>* Other names: Robot assisted Radical Prostatectomy;Radiation: SBRT<br>* Stereotactic body radiotherapy to osseous lesions<br>* Other names: Stereotactic body radiotherapy;Drug: ADT<br>* six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.<br>* Other names: Androgen deprivation therpay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of men with Grade ≥ 3 adverse events the first year | Proportion of men with Grade ≥ 3 adverse events the first year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml | Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml | 1 year | 
| Feasibility of radical prostatectomy in the oligometastatic setting | Feasibility of radical prostatectomy in the oligometastatic setting measured as number of patients who successfully undergo radical prostatectomy with pelvic lymphnode disection and 30 days (post-operative) morbidity according to the Clavian Dindo Classification. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy, prostatectomy, androgen deprivation therapy