Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients

  • STATUS
    Recruiting
  • End date
    Dec 20, 2027
  • participants needed
    350
  • sponsor
    UNICANCER
Updated on 20 September 2020
Investigator
Sandra Pelissier
Primary Contact
Institut de Canc rologie Lucien Neuwirth (0.0 mi away) Contact
+20 other location

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.

Details
Treatment Standard of Care, Stereotactic Body Radiotherapy (SBRT)
Clinical Study IdentifierNCT04115007
SponsorUNICANCER
Last Modified on20 September 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have Oligometastatic Hormone Sensitive Prostate Cancer?
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
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