prostate-cancer treatment using stereotactic radiotherapy for oligometastases ablation in hormone-sensitive patients

Conditions: Oligometastatic Hormone Sensitive Prostate Cancer

Summary: indication: oligometastatic hormone-sensitive prostate cancer patients. methodology: open label, double arm, randomized 1:1, multicenter phase iii study. primary objective: to assess the efficacy of ablative radiotherapy (sbrt applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients.


Eligibility criteria:
diagnosis and inclusion criteria: 1. histologically proven adenocarcinoma of the prostate (any t stage, gleason score, or prostate specific antigen (psa) level); 2. defined as m1 based on the presence of at least one bone metastasis; 3. diagnostic workup including functional imaging (f or c-choline-pet/ct or prostate specific membrane antigen (psma) pet/ct or whole body mri) - done prior to the start of hormonal therapy; 4. with up to 5 asymptomatic or paucisymptomatic metastatic sites including at least one bone +/- pulmonary lesion +/- nodal mestastases. are counted as a "separate" metastatic site : * each bone lesion, whatever the location (including pelvic localization), except if two lesions show hyperfixation in the same bone and are located \< 1cm from each other they can be counted as one lesion * each node or nodal area located outside the true pelvis with a small diameter of 1cm or greater or with univoqual abnormal function imaging (pet scan hyperfixation or hypersignal in whole body mri); if multiple nodes are in close vicinity (\<1cm distance between them and \<4cm in total distance including the nodes, amenable to one sbrt treatment) they can be counted as one lesion * and patients with lung metastasis can be included 5. 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; 6. age ≥18 years; 7. eastern cooperative oncology group (ecog) ≤2; 8. suitable for long term anti androgen therapy; 9. patient not suitable for docetaxel or abiraterone can be included; 10. patient that have started long term hormonal therapy are eligible if hormonal therapy has been initiated less than 2 months before randomization; 11. patients must agree to use adequate contraception methods for the duration of study treatment and for 6 months after completing treatment; 12. patient must have received the information sheet and signed the consent form; 13. 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; 14. patient must be affiliated to the social security system. non-inclusion criteria: 1. patient with more than 5 metastatic sites; 2. patient with isolated rib hyperfixation on functional imaging without a clear correlate on morphological imaging; 3. patient with metastatic sites other than bone, lymph nodes or lung; 4. metastases not amenable to radiotherapy treatment with high/curative doses by multidisciplinary meeting \[i.e. sbrt as per protocol or curative doses using moderate hypofractionation (55-60gy/20) or conventional fractionation (≥74 gy)\] (e.g. gross epidural involvement, involvement of three contiguous vertebral bodies, major soft tissue involvement, and previous radiation treatment); 5. metastases requiring immediate treatment due to significant pain (use of opioid medication), or at risk of fracture or neurological deficit; 6. prior radiotherapy or focal ablative treatment (cryotherapy, radiofrequency ablation,...) to metastatic lesions; 7. patients previously treated by hormonotherapy with castrate testosterone level \<50 ng/dl or ≤0.50 ng/ml or 1.73 nmol/l prior use of adt; 8. prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for ≥5 years; 9. contra-indication to mri (needed for spinal sbrt); 10. persons deprived of their liberty or under protective custody or guardianship; 11. patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons; 12. participation in another therapeutic trial within 30 days prior to randomization.