Phase
Condition
Allergy (Pediatric)
Allergy
Urologic Cancer
Treatment
Standard of care
Stereotactic Body Radiotherapy (SBRT) + Standard of care
Clinical Study ID
Ages > 18 Male
Study Summary
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.
Study Design
Connect with a study center
ICO Paul Papin
Angers, 49055
FranceSite Not Available
Institut Sainte Catherine
Avignon, 80005
FranceActive - Recruiting
Institut Bergonié
Bordeaux, 33076
FranceActive - Recruiting
CHRU de Brest
Brest, 29200
FranceActive - Recruiting
Centre d'oncologie - Clinique Pasteur
Brest, 29200
FranceActive - Recruiting
Centre François Baclesse
Caen, 14000
FranceActive - Recruiting
Centre Jean Perrin
Clermont-Ferrand, 63000
FranceActive - Recruiting
Centre Amethyst de Creil
Creil, 60100
FranceActive - Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
FranceActive - Recruiting
Institut de cancérologie de Seine et Marne - Clinique de Jossiny
Jossigny, 77650
FranceSite Not Available
Centre Oscar Lambret
Lille, 59020
FranceActive - Recruiting
Groupe Hospitalier Bretagne Sud
Lorient, 56000
FranceActive - Recruiting
Centre Leon Berard
Lyon, 69008
FranceActive - Recruiting
Institut Paoli Calmettes
Marseille, 13009
FranceActive - Recruiting
Hôpital de Mercy
Metz, 57085
FranceSite Not Available
Centre Azureen de Cancerologie
Mougins, 06250
FranceActive - Recruiting
Hôpital Privé du Confluent
Nantes, 44277
FranceActive - Recruiting
ICO René Gauducheau
Nantes, 44805
FranceActive - Recruiting
Centre Antoine Lacassagne
Nice, 06189
FranceActive - Recruiting
Institut Curie
Paris, 75005
FranceActive - Recruiting
CHU Bordeaux Hôpital Haut Lévêque
Pessac, 33600
FranceSite Not Available
CHU Lyon Sud
Pierre-Bénite, 69495
FranceActive - Recruiting
CH Annecy
Pringy, 74374
FranceActive - Recruiting
Institut du Cancer Courlancy
Reims, 51100
FranceActive - Recruiting
Centre Eugene Marquis
Rennes, 35042
FranceActive - Recruiting
CHU de Rouen - Charles Nicole
Rouen, 76031
FranceSite Not Available
Centre Henri Becquerel
Rouen, 76038
FranceSite Not Available
CHP Saint Grégoire
Saint Gregoire, 35760
FranceActive - Recruiting
HIA Begin
Saint-Mandé, 94160
FranceActive - Recruiting
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42271
FranceSite Not Available
Institut de cancérologie et d'hématologie universitaire de Saint Etienne
Saint-Étienne, 42055
FranceActive - Recruiting
Institut de Cancerologie Paris Nord
Sarcelles, 95200
FranceActive - Recruiting
Institut de cancérologie Strasbourg Europe (ICANS )
Strasbourg, 67065
FranceActive - Recruiting
Clinique PASTEUR
Toulouse, 31076
FranceActive - Recruiting
IUCT- Oncopole -Institut Claudius Regaud
Toulouse, 31059
FranceActive - Recruiting
CHU Bretonneau
Tours, 37044
FranceSite Not Available
Centre de radiothérapie Marie Curie de Valence
Valence, 26000
FranceActive - Recruiting
Centre Amethyst - Oncologie 78
Versailles, 78000
FranceSite Not Available
Gustave Roussy Cancer Campus Grand Paris
Villejuif, 94805
FranceActive - Recruiting
CHU Martinique
Fort-de-France, 97261
MartiniqueActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.