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

Overview

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.

Full Title of Study: “Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2023

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.

Arms, Groups and Cohorts

  • Experimental: RARP + SBRT + ADT
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of men with Grade ≥ 3 adverse events the first year
    • Time Frame: 1 year
    • Proportion of men with Grade ≥ 3 adverse events the first year

Secondary Measures

  • Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml
    • Time Frame: 1 year
    • Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml
  • Feasibility of radical prostatectomy in the oligometastatic setting
    • Time Frame: 1 year
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Age 18 years or older and willing and able to provide informed consent;

2. Stage cT1 ≤ cT3b, Clinical resectable

3. Gleason score ≥ 6

4. M1

1. ≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68Ga-PSMA PET/CT and magnetic resonance imaging (MRi)

2. 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.

3. No visceral metastasis

4. Metastases suitable for stereotactic body radiotherapy

5. Non symptomatic bone lesions

5. Eligible for surgery

Exclusion Criteria

1. Prior curative intended treatment for prostate cancer

2. Prior androgen deprivation therapy (ADT)

3. 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.

4. Eastern Cooperative Oncology Group (ECOG) Performance Status > 1

5. Evaluated not able to fulfil the study protocol.

6. Contraindications against MRI

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peter Busch Østergren
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Peter Busch Østergren, Principal Investigator – Herlev Hospital
  • Overall Official(s)
    • Peter B Østergren, MD, Principal Investigator, Herlev and Gentofte Hospital
  • Overall Contact(s)
    • Peter B Østergren, MD, +4538681505, peter.busch.oestergren@regionh.dk

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