Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients. (OLIGORESIST)
16. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
51
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Pablo Raña Diez, PhD
- Telefonnummer: +34 696633409
- E-post: investigacion@seor.es
Studer Kontakt Backup
- Navn: Cristina Gutierrez Povedano, PhD
- Telefonnummer: +34 675039150
- E-post: cristina.gutierrez.povedano@navarra.es
Studiesteder
-
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Aragon
-
Zaragoza, Aragon, Spania, 50009
- Aktiv, ikke rekrutterende
- Hospital Universitario Miguel Servet
-
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Barcelona
-
Barcelona, Barcelona, Spania, 08036
- Rekruttering
- Hospital Clinic de Barcelona
-
Ta kontakt med:
- Joel Mases, MD
- E-post: mases@clinic.cat
-
Hovedetterforsker:
- Joel Mases i Rosinés, MD
-
Underetterforsker:
- Elías Gomís, MD
-
Underetterforsker:
- Sara Moreno, MD
-
Underetterforsker:
- Gerard Meca, MD
-
L'Hospitalet de Llobregat, Barcelona, Spania, 08908
- Rekruttering
- Instituto Catalán de Oncología Hospitalet
-
Ta kontakt med:
- Anna Maria Boladeras, MD
- E-post: aboladeras@iconcologia.net
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Hovedetterforsker:
- Ana María Boladeras Inglada, MD
-
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Basque Country
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Bilbao, Basque Country, Spania, 48013
- Aktiv, ikke rekrutterende
- Hospital Universitario Basurto
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Castille and León
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Salamanca, Castille and León, Spania, 37007
- Aktiv, ikke rekrutterende
- Hospital Universitario De Salamanca
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Valladolid, Castille and León, Spania, 47003
- Rekruttering
- Hospital Clínico Universitario de Valladolid
-
Ta kontakt med:
- Patricia Diezhandino Garcia, MD
- Telefonnummer: +34 983 420 003
- E-post: pdiezhandino@saludcastillayleon.es
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Hovedetterforsker:
- Patricia Diezhandino Garcia, MD
-
-
Catalonia
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Barcelona, Catalonia, Spania, 08041
- Rekruttering
- Hospital de La Santa Creu i Sant Pau
-
Ta kontakt med:
- Gemma Sancho Pardo, MD
- Telefonnummer: +34 935537756
- E-post: gsancho@santpau.cat
-
Ta kontakt med:
- Saudy Peláez Bonilla, Study coordinator
- Telefonnummer: 776 +34 935537760
- E-post: SPelaez@santpau.cat
-
Underetterforsker:
- Arantxa Mera Errasti, MD
-
Hovedetterforsker:
- Gemma Sancho Pardo, MD
-
Underetterforsker:
- Laura Montezuma Niño, MD
-
Underetterforsker:
- Ana Maria Soto Cambres, MD
-
Terrassa, Catalonia, Spania, 08227
- Aktiv, ikke rekrutterende
- Consorci Sanitari de Terrassa
-
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Galicia
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Santiago de Compostela, Galicia, Spania, 15706
- Aktiv, ikke rekrutterende
- Complexo Hospitalario Universitario De Santiago
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Madrid
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Madrid, Madrid, Spania, 28040
- Rekruttering
- Hospital Clinico San Carlos
-
Ta kontakt med:
- Noelia Sanmamed, MD
- Telefonnummer: +34 985 10 80 00
- E-post: noelia.sanmamed@salud.madrid.org
-
Hovedetterforsker:
- Noelia Sanmamed Salgado, MD
-
Underetterforsker:
- Manuel Gonzalo Vázquez Masedo, MD
-
Underetterforsker:
- Miren Gaztañaga Boronat, MD
-
Underetterforsker:
- Maria Nieves Cabrera Martin, MD
-
Underetterforsker:
- Natalia Vidal Cassinello, MD
-
Underetterforsker:
- Anxela Doval Gonzalez, MD
-
Underetterforsker:
- Javier Puente Vazquez, MD
-
Underetterforsker:
- Ignacio Moreno, MD
-
Madrid, Madrid, Spania, 28034
- Aktiv, ikke rekrutterende
- Hospital Ramon y Cajal
-
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Navarre
-
Pamplona, Navarre, Spania, 31008
- Rekruttering
- Hospital Universitario de Navarra (HUN)
-
Hovedetterforsker:
- Marta Barrado Los Arcos, MD
-
Ta kontakt med:
- Marta Barrado Los Arcos, MD
- Telefonnummer: +34 848 42 84 82
- E-post: marta.barrado.losarcos@navarra.es
-
Underetterforsker:
- Amaya Sola Galarza, MD
-
Underetterforsker:
- Elena Villafranca Iturre, MD
-
Underetterforsker:
- Ignacio Visus Fernandez de Manzanos, MD
-
Underetterforsker:
- Nuria Bultó Boque, MD
-
Underetterforsker:
- Xabier Gurutzeaga Peleato, MD
-
-
Principality of Asturias
-
Oviedo, Principality of Asturias, Spania, 33011
- Aktiv, ikke rekrutterende
- Hospital Universitario Central de Asturias
-
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Valencia
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Valencia, Valencia, Spania, 46026
- Aktiv, ikke rekrutterende
- Hospital Universitario y Politécnico de La Fe
-
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Vizcaya
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Barakaldo, Vizcaya, Spania, 48903
- Aktiv, ikke rekrutterende
- Hospital De Cruces
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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)
Andre navn:
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Determine the PRFS
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Marta Barrado Los Arcos, MD, Hospital of Navarra
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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- Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10. doi: 10.1200/JCO.1995.13.1.8. No abstract available.
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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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- Kirby M, Hirst C, Crawford ED. Characterising the castration-resistant prostate cancer population: a systematic review. Int J Clin Pract. 2011 Nov;65(11):1180-92. doi: 10.1111/j.1742-1241.2011.02799.x.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. mai 2024
Primær fullføring (Antatt)
16. mai 2030
Studiet fullført (Antatt)
16. mai 2030
Datoer for studieregistrering
Først innsendt
13. juli 2026
Først innsendt som oppfylte QC-kriteriene
16. juli 2026
Først lagt ut (Faktiske)
21. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Genitale neoplasmer, hanner
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kjønnssykdommer, mannlige
- Prostata sykdommer
- Mannlige urogenitale sykdommer
- Prostatiske neoplasmer
- Prostatiske neoplasmer, kastrasjonsresistente
- Polysykliske forbindelser
- Steroider
- Smeltede ringforbindelser
- Androstenes
- Androstanes
- Abirateronacetat
- Enzalutamid
Andre studie-ID-numre
- IRA-RAD-2022-001
- 2023-505024-62 (EudraCT-nummer)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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