Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients. (OLIGORESIST)
16 juillet 2026 mis à jour par: Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
Radioterapia estereotáctica Fraccionada más antiandrógeno de Segunda generación Para Pacientes oligometastásicos Con cáncer de próstata Resistente a la castración. Estudio español Fase II, Prospectivo, multicéntrico.
The objectives of the study are to analyze the results obtained in survival, safety and quality of life after the combination of SBRT plus second-generation antiandrogen in patients diagnosed with metastatic castration-resistant prostate cancer in oligometastasis (≤5).
Hence, the investigators evaluate the results of the combination of two widely used treatments in prostate cancer: SBRT plus the 'standard of care' for patients with mCRPC, second-generation antiandrogens (abiraterone and enzalutamide).
Primary objective: Determine the PRFS measured from the time of initiation of second-generation antiandrogen to the time of radiological progression by choline PET/CT or 68Ga-PSMA PET/CT, in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.
Secondary objectives:
- Overall survival (time from initiation of second-generation antiandrogen to exitus) in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.
- Quality of life of these patients using the European Organization for Research and Treatment of Cancer (EORTC) quality of life scale, EORTC QLQ-C30, validated for oncology patients.
- Acute and chronic toxicity according to the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0) scale.
This is a phase II, multicenter, prospective, single group study in patients with castrate-resistant prostate cancer (CRPC).
Patients will be recruited at the participant sites, after study approval and hospital authorization.
51 patients will be included in the study. Eligible patients will require:
- Choline PET/CT or 68Ga-PSMA PET/CT, dated no more than 8 weeks prior to inclusion.
- Clinical history, physical examination and functional evaluation scale (ECOG).
- Geriatric assessment scale for patients > 75 years (modified G8 scale)
- Toxicity scale assessment (CTCAEv5.0)
- Baseline quality of life questionnaire (EORTC QLQ-C30) (47)
- Blood tests with complete blood count, coagulation, liver function, renal function, ions, alkaline phosphatase, PSA and total and free testosterone, dated no more than 4 weeks prior inclusion.
- Inclusion/exclusion criteria assessment
- Second generation antiandrogen prescription, chosen by the responsible physician according to clinical practice, in each case.
Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus). SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and/or exitus.
Recruitment time is estimated at 36 months and a total follow-up time of 36 months. The total duration of the trial is therefore expected to be 6 years, to allow complete follow-up of the last patients included.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
51
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Pablo Raña Diez, PhD
- Numéro de téléphone: +34 696633409
- E-mail: investigacion@seor.es
Sauvegarde des contacts de l'étude
- Nom: Cristina Gutierrez Povedano, PhD
- Numéro de téléphone: +34 675039150
- E-mail: cristina.gutierrez.povedano@navarra.es
Lieux d'étude
-
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Aragon
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Zaragoza, Aragon, Espagne, 50009
- Actif, ne recrute pas
- Hospital Universitario Miguel Servet
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Barcelona
-
Barcelona, Barcelona, Espagne, 08036
- Recrutement
- Hospital Clinic de Barcelona
-
Contact:
- Joel Mases, MD
- E-mail: mases@clinic.cat
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Chercheur principal:
- Joel Mases i Rosinés, MD
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Sous-enquêteur:
- Elías Gomís, MD
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Sous-enquêteur:
- Sara Moreno, MD
-
Sous-enquêteur:
- Gerard Meca, MD
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L'Hospitalet de Llobregat, Barcelona, Espagne, 08908
- Recrutement
- Instituto Catalán de Oncología Hospitalet
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Contact:
- Anna Maria Boladeras, MD
- E-mail: aboladeras@iconcologia.net
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Chercheur principal:
- Ana María Boladeras Inglada, MD
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Basque Country
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Bilbao, Basque Country, Espagne, 48013
- Actif, ne recrute pas
- Hospital Universitario Basurto
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Castille and León
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Salamanca, Castille and León, Espagne, 37007
- Actif, ne recrute pas
- Hospital Universitario De Salamanca
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Valladolid, Castille and León, Espagne, 47003
- Recrutement
- Hospital Clínico Universitario de Valladolid
-
Contact:
- Patricia Diezhandino Garcia, MD
- Numéro de téléphone: +34 983 420 003
- E-mail: pdiezhandino@saludcastillayleon.es
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Chercheur principal:
- Patricia Diezhandino Garcia, MD
-
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Catalonia
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Barcelona, Catalonia, Espagne, 08041
- Recrutement
- Hospital de La Santa Creu i Sant Pau
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Contact:
- Gemma Sancho Pardo, MD
- Numéro de téléphone: +34 935537756
- E-mail: gsancho@santpau.cat
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Contact:
- Saudy Peláez Bonilla, Study coordinator
- Numéro de téléphone: 776 +34 935537760
- E-mail: SPelaez@santpau.cat
-
Sous-enquêteur:
- Arantxa Mera Errasti, MD
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Chercheur principal:
- Gemma Sancho Pardo, MD
-
Sous-enquêteur:
- Laura Montezuma Niño, MD
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Sous-enquêteur:
- Ana Maria Soto Cambres, MD
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Terrassa, Catalonia, Espagne, 08227
- Actif, ne recrute pas
- Consorci Sanitari de Terrassa
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Galicia
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Santiago de Compostela, Galicia, Espagne, 15706
- Actif, ne recrute pas
- Complexo Hospitalario Universitario De Santiago
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Madrid
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Madrid, Madrid, Espagne, 28040
- Recrutement
- Hospital Clinico San Carlos
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Contact:
- Noelia Sanmamed, MD
- Numéro de téléphone: +34 985 10 80 00
- E-mail: noelia.sanmamed@salud.madrid.org
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Chercheur principal:
- Noelia Sanmamed Salgado, MD
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Sous-enquêteur:
- Manuel Gonzalo Vázquez Masedo, MD
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Sous-enquêteur:
- Miren Gaztañaga Boronat, MD
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Sous-enquêteur:
- Maria Nieves Cabrera Martin, MD
-
Sous-enquêteur:
- Natalia Vidal Cassinello, MD
-
Sous-enquêteur:
- Anxela Doval Gonzalez, MD
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Sous-enquêteur:
- Javier Puente Vazquez, MD
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Sous-enquêteur:
- Ignacio Moreno, MD
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Madrid, Madrid, Espagne, 28034
- Actif, ne recrute pas
- Hospital Ramon y Cajal
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Navarre
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Pamplona, Navarre, Espagne, 31008
- Recrutement
- Hospital Universitario de Navarra (HUN)
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Chercheur principal:
- Marta Barrado Los Arcos, MD
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Contact:
- Marta Barrado Los Arcos, MD
- Numéro de téléphone: +34 848 42 84 82
- E-mail: marta.barrado.losarcos@navarra.es
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Sous-enquêteur:
- Amaya Sola Galarza, MD
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Sous-enquêteur:
- Elena Villafranca Iturre, MD
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Sous-enquêteur:
- Ignacio Visus Fernandez de Manzanos, MD
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Sous-enquêteur:
- Nuria Bultó Boque, MD
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Sous-enquêteur:
- Xabier Gurutzeaga Peleato, MD
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Principality of Asturias
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Oviedo, Principality of Asturias, Espagne, 33011
- Actif, ne recrute pas
- Hospital Universitario Central de Asturias
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Valencia
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Valencia, Valencia, Espagne, 46026
- Actif, ne recrute pas
- Hospital Universitario y Politécnico de La Fe
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Vizcaya
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Barakaldo, Vizcaya, Espagne, 48903
- Actif, ne recrute pas
- Hospital De Cruces
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Patients with histologically prostate adenocarcinoma, confirmed with a biopsy.
- Testosterone in biochemical castration ranges (testosterone <50 ng/ml or 1.7 nmol/L) and documented progression: biochemical according to Phoenix criteria or distant by radiological confirmation (PSMA PET/CT or Choline PET/CT)
- Biochemistry progression confirmed according to Phoenix criteria, with testosterone in castration levels (testosterone <50 ng/ml or 1.7 nmol/L).
- Radiological confirmation (with choline-PET/CT or 68Ga-PSMA-PET/CT) of ≤5 node or bone metastasis, non-visceral, eligible to receive SBRT treatment (< 3 cm major diameter in bone metastases, < 5 cm in lymph node metastases). In the case of very close metastases, a limit of up to 5 treatment fields with SBRT is allowed, instead of 5 metastases.
- Patients candidate to receive treatment with abiraterone or enzalutamide as per clinical routine, and treatment selection and prescription assigned by responsible physician before the inclusion in the study. or or who has started treatment no more than 14 days prior to signing, as first-line treatment after a diagnosis of oligoresistance.
- Patients must provide written informed consent.
- Life expectancy > 3 months.
Exclusion Criteria:
- Patients with prostate carcinoma with histology other than adenocarcinoma.
- No previous biopsy.
- > 5 metastasis, not approachables in 5 treatment fields
- Patients with visceral metastasis and or metastasis non elegible to receive SBRT.
- Patients with Testosterone above castration levels
- Patients with prior treatment with docetaxel as first-line CRPC treatment (previous docetaxel treatment is permitted when administered as hormone-sensitive metastatic prostate cancer treatment.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Second generation antiandrogen plus SBRT
Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus).
SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and/or exitus
|
Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus)
Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus)
Autres noms:
SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and/or exitus
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Determine the PRFS
Délai: From the start of the study (the day it begins) or up to 14 days before the start of the study (corresponding to the start of treatment with second-generation antiandrogens) until the time of radiological progression during follow-up, it can be up to 36.
|
Determine the PRFS measured from the time of initiation of second-generation antiandrogen to the time of radiological progression by choline PET/CT or 68Ga-PSMA PET/CT, in patients with mCRPC treated with the combination of second-generation antiandrogen
|
From the start of the study (the day it begins) or up to 14 days before the start of the study (corresponding to the start of treatment with second-generation antiandrogens) until the time of radiological progression during follow-up, it can be up to 36.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall survival
Délai: From the start of second-generation antiandrogen therapy (at baseline or up to 14 days prior) to the date of death from any cause, assessed up to 36 months.
|
Overall survival (time from initiation of second-generation antiandrogen to exitus) in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.
|
From the start of second-generation antiandrogen therapy (at baseline or up to 14 days prior) to the date of death from any cause, assessed up to 36 months.
|
|
Quality of life by EORTC scale
Délai: from recruitment to the end of patient follow-up (up to 36 months)
|
QoL using the European Organization for Research and Treatment of Cancer (EORTC) quality of life scale, EORTC QLQ-C30, validated for oncology patients. The scale converts all scores to a standardized range from 0 (minimum) to 100 (maximum). A high score indicates a better outcome (high quality of life and good health). |
from recruitment to the end of patient follow-up (up to 36 months)
|
|
Acute and chronic toxicity
Délai: from recruitment to the end of patient follow-up (up to 36 months)
|
Acute and chronic toxicity according to the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0)
scale
|
from recruitment to the end of patient follow-up (up to 36 months)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Marta Barrado Los Arcos, MD, Hospital of Navarra
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
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- Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. doi: 10.1056/NEJMoa1405095. Epub 2014 Jun 1.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
16 mai 2024
Achèvement primaire (Estimé)
16 mai 2030
Achèvement de l'étude (Estimé)
16 mai 2030
Dates d'inscription aux études
Première soumission
13 juillet 2026
Première soumission répondant aux critères de contrôle qualité
16 juillet 2026
Première publication (Réel)
21 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Tumeurs génitales, homme
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies génitales, sexe masculin
- Maladies de la prostate
- Maladies urogénitales masculines
- Tumeurs prostatiques
- Tumeurs prostatiques, résistantes à la castration
- Composés polycycliques
- Stéroïdes
- Composés à anneau fusionné
- Androsténes
- Androstanes
- Acétate d'abiratérone
- enzalutamide
Autres numéros d'identification d'étude
- IRA-RAD-2022-001
- 2023-505024-62 (Numéro EudraCT)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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