Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients – a GETUG-AFU Phase III Randomized Controlled Trial

Condition: Oligometastatic Hormone Sensitive Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04115007


Phase: Phase 3


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the prostate (any T stage, Gleason score or prostate-specific antigen (PSA) level)
  • Defined as M1 based on the presence of at least one bone metastasis
  • Diagnostic workup including functional imaging (F- or C-Choline-PET/CT, Prostate Specific Membrane Antigen (PSMA) PET/CT or whole body MRI) and Computed Tomography of Thorax, Abdomen and Pelvis (CT-TAP) done before the start of hormonal therapy
  • With up to 5 asymptomatic or paucisymptomatic metastatic sites including at least one bone lesion with or without nodal metastases. Are counted as a separate metastasis each bone lesion and each node located outside the true pelvis with a small diameter of 1 cm or greater or with univocal abnormal function imaging (PET Scan hyperfixation or hypersignal in whole body MRI)
  • Patients with a previous prostatectomy or radiotherapy to the prostate and/or pelvic lymph nodes are eligible provided they have no active disease within the irradiated areas, based on functional imaging findings
  • Age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) ≤2
  • Suitable for long term anti androgen therapy
  • Patient not suitable for docetaxel or abiraterone can be included
  • Patient that have started long term hormonal therapy are eligible if hormonal therapy has been initiated less than 2 months before randomization
  • Patients must agree to use adequate contraception methods for the duration of study treatment and for 6 months after completing treatment
  • Patient must have received the information sheet and signed the consent form
  • Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures
  • Patient must be affiliated to the social security system.

Exclusion Criteria:

  • Patient with more than 5 metastatic sites
  • Patient with metastatic sites other than bone or lymph nodes (lung, brain, or liver metastases)
  • Metastases not amenable to stereotactic body radiotherapy by multidisciplinary meeting (e.g. gross epidural involvement, involvement of three contiguous vertebral bodies, major soft tissue involvement, and previous radiation treatment)
  • Metastases requiring immediate treatment due to significant pain (use of opioid medication), or at risk of fracture or neurological deficit
  • Castrate testosterone level <50 ng/dL or ≤0.50 ng/mL or 1.73 nmol/L prior use of ADT
  • Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for ≥5 years
  • Contra-indication to MRI (needed for spinal SBRT)
  • Persons deprived of their liberty or under protective custody or guardianship;
  • Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
  • Participation in another therapeutic trial within 30 days prior to randomization.

View trial on ClinicalTrials.gov