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

Sponsor: UNICANCER

Phase: Phase 3

Eligibility:

• 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