Status:
ACTIVE_NOT_RECRUITING
Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients
Lead Sponsor:
UNICANCER
Conditions:
Oligometastatic Hormone Sensitive Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- DIAGNOSIS AND 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 or prostate specific membrane antigen (PSMA) PET/CT or whole body MRI) - done prior to the start of hormonal therapy;
- 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
- 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.
- NON-INCLUSION CRITERIA:
- Patient with more than 5 metastatic sites;
- Patient with isolated Rib hyperfixation on functional imaging without a clear correlate on morphological imaging;
- Patient with metastatic sites other than bone, lymph nodes or lung;
- 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);
- Metastases requiring immediate treatment due to significant pain (use of opioid medication), or at risk of fracture or neurological deficit;
- Prior radiotherapy or focal ablative treatment (cryotherapy, radiofrequency ablation,…) to metastatic lesions;
- 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;
- 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.
Exclusion
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2031
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT04115007
Start Date
June 23 2020
End Date
February 28 2031
Last Update
June 26 2025
Active Locations (35)
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1
Institut Sainte Catherine
Avignon, France, 80005
2
Institut Bergonié
Bordeaux, France, 33076
3
Centre d'oncologie - Clinique Pasteur
Brest, France, 29200
4
CHRU de Brest
Brest, France, 29200