Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer

The study is an open label, multi-centre, randomized phase III study. The patients will be randomised in a 1:1 ratio to treatment consisting of * Arm A: MD-SBRT in addition to standard treatment * Arm B: Standard treatment Study population: Patients with hormone sensitive prostate cancer (HSPC) with oligometastatic disease detected by PSMA-PET/DT. This includes patients with de novo oligometastatic HSPC and recurrent HSPC after primary RT or prostatectomy. Primary endpoint: Failure free survival Secondary endpoints: * Predictive value of investigated biomarkers in blood and imaging * Acut

Trial Details

NCT ID
NCT04983095
Phase
NA
Sponsor
Karin Soderkvist
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • stereotactic body radiotherapy
  • androgen deprivation therapy
  • Radiotherapy
Locations (sample)
  • Lund, Lund, Sweden|55.70584,13.19321
  • Stockholm, Region Stockholm, Sweden|59.32938,18.06871
  • Stockholm, Region Stockholm, Sweden|59.32938,18.06871
  • Stockholm, Stockholm County, Sweden|59.32938,18.06871
  • Umeå, Umea, Sweden|63.82842,20.25972

Key Eligibility Criteria

  • Histologically confirmed prostate cancer (ICD-O-3 C61)
  • WHO/ECOG performance status 0-1
  • 1-3 skeletal or extra pelvic lymph node metastases detected by PSMA-PET/CT in de novo prostate cancer or PSA-relapse after definitive RT or prostat…
  • Willing and able to provide informed consent-

For full eligibility, visit ClinicalTrials.gov.

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