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Recruiting NCT04086290

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

Phase I / Phase II Interventional Prostate Cancer Metastatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RARP, SBRT, ADT.
Who it may be relevant to
Registry conditions: Prostate Cancer Metastatic. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Oligomet-DK. 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.

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.

Primary outcome measures

  • Proportion of men with Grade ≥ 3 adverse events the first year [Time frame: 1 year]
Secondary outcome measures (2)
  • Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml [Time frame: 1 year]
  • Feasibility of radical prostatectomy in the oligometastatic setting [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Herlev and Gentofte Hospital — Herlev

Identifiers

NCT: NCT04086290 · Oligomet_DK

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗