Informations générales (source: ClinicalTrials.gov)
Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients - a GETUG-AFU Phase III Randomized Controlled Trial (Oligo-PRESTO)
Interventional
Phase 3
UNICANCER (Voir sur ClinicalTrials)
juin 2020
février 2031
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:44 | Contacter | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHI DE CRETEIL | Wassila Boukhelif, MD | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Pierre BLANCHARD, MD | Contact (sur clinicalTrials) | |||
| HIA BEGIN | Carole HELISSEY, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Amethyst - Oncologie 78 - 78000 - Versailles - France | Antoine Schernberg, MD | Contact (sur clinicalTrials) | |||
| Centre Amethyst de Creil - 60100 - Creil - France | Pierre MAROUN, MD | Contact (sur clinicalTrials) | |||
| Centre Antoine Lacassagne - 06189 - Nice - France | Flora COURTAULT-DESLANDES, MD | Contact (sur clinicalTrials) | |||
| Centre Azureen de Cancerologie - 06250 - Mougins - France | Philippe RONCHIN, MD | Contact (sur clinicalTrials) | |||
| Centre de radiothérapie Marie Curie de Valence - 26000 - Valence - France | Jean-Baptiste GUY, MD | Contact (sur clinicalTrials) | |||
| Centre d'oncologie - Clinique Pasteur - 29200 - Brest - France | Ali HASBINI | Contact (sur clinicalTrials) | |||
| Centre Eugene Marquis - 35042 - Rennes - France | Manon BATY, MD | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - 14000 - Caen - France | Emmanuel MEYER, MD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - 76038 - Rouen - France | Ahmed Benyoucef, MD | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - 63000 - Clermont-Ferrand - France | Genevieve LOOS, MD | Contact (sur clinicalTrials) | |||
| Centre Leon Berard - 69008 - Lyon - France | Cécile Laude, MD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59020 - Lille - France | David PASQUIER, MD | Contact (sur clinicalTrials) | |||
| CH Annecy - 74374 - Pringy - France | Johan KRISTIANSEN, MD | Contact (sur clinicalTrials) | |||
| CHP Saint Grégoire - 35760 - Saint Gregoire - France | Jérôme CHAMOIS, Dr | Contact (sur clinicalTrials) | |||
| CHRU de Brest - 29200 - Brest - France | Ulrike SCHICK, MD | Contact (sur clinicalTrials) | |||
| CHU de Rouen - Charles Nicole - 76031 - Rouen - France | Laetitia Augusto, MD | Contact (sur clinicalTrials) | |||
| CHU Lyon Sud - 69495 - Pierre-Bénite - France | Olivier CHAPET, Prof | Contact (sur clinicalTrials) | |||
| Clinique PASTEUR - 31076 - Toulouse - France | Igor LATORZEFF, MD | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier Bretagne Sud - 56000 - Lorient - France | Guillaume BERA, MD | Contact (sur clinicalTrials) | |||
| Hôpital Privé du Confluent - 44277 - Nantes - France | Christophe Blay, MD | Contact (sur clinicalTrials) | |||
| ICO René Gauducheau - 44805 - Nantes - France | Stéphane SUPIOT, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - 33076 - Bordeaux - France | Paul SARGOS, MD | Contact (sur clinicalTrials) | |||
| Institut de cancérologie de Seine et Marne - Clinique de Jossiny - 77650 - Jossigny - France | Anne-Caroline Daveau, MD | Contact (sur clinicalTrials) | |||
| Institut de cancérologie et d'hématologie universitaire de Saint Etienne - 42055 - Saint-Étienne - France | Thomas Reynaud, Dr | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie Paris Nord - 95200 - Sarcelles - France | Lauriane Colson, MD | Contact (sur clinicalTrials) | |||
| Institut de cancérologie Strasbourg Europe (ICANS ) - 67065 - Strasbourg - France | Inès MENOUX, MD | Contact (sur clinicalTrials) | |||
| Institut du Cancer Courlancy - 51100 - Reims - France | Frédéric MALLET, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - 13009 - Marseille - France | Gwenaëlle GRAVIS, MD | Contact (sur clinicalTrials) | |||
| Institut Sainte Catherine - 80005 - Avignon - France | Lysian CARTIER, MD | Contact (sur clinicalTrials) | |||
| IUCT- Oncopole -Institut Claudius Regaud - 31059 - Toulouse - France | Jonathan KHALIFA, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
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.
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.