Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients. (OLIGORESIST)
16. juli 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
51
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Pablo Raña Diez, PhD
- Telefonnummer: +34 696633409
- E-mail: investigacion@seor.es
Undersøgelse Kontakt Backup
- Navn: Cristina Gutierrez Povedano, PhD
- Telefonnummer: +34 675039150
- E-mail: cristina.gutierrez.povedano@navarra.es
Studiesteder
-
-
Aragon
-
Zaragoza, Aragon, Spanien, 50009
- Aktiv, ikke rekrutterende
- Hospital Universitario Miguel Servet
-
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Barcelona
-
Barcelona, Barcelona, Spanien, 08036
- Rekruttering
- Hospital Clinic de Barcelona
-
Kontakt:
- Joel Mases, MD
- E-mail: mases@clinic.cat
-
Ledende efterforsker:
- Joel Mases i Rosinés, MD
-
Underforsker:
- Elías Gomís, MD
-
Underforsker:
- Sara Moreno, MD
-
Underforsker:
- Gerard Meca, MD
-
L'Hospitalet de Llobregat, Barcelona, Spanien, 08908
- Rekruttering
- Instituto Catalán de Oncología Hospitalet
-
Kontakt:
- Anna Maria Boladeras, MD
- E-mail: aboladeras@iconcologia.net
-
Ledende efterforsker:
- Ana María Boladeras Inglada, MD
-
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Basque Country
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Bilbao, Basque Country, Spanien, 48013
- Aktiv, ikke rekrutterende
- Hospital Universitario Basurto
-
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Castille and León
-
Salamanca, Castille and León, Spanien, 37007
- Aktiv, ikke rekrutterende
- Hospital Universitario De Salamanca
-
Valladolid, Castille and León, Spanien, 47003
- Rekruttering
- Hospital Clínico Universitario de Valladolid
-
Kontakt:
- Patricia Diezhandino Garcia, MD
- Telefonnummer: +34 983 420 003
- E-mail: pdiezhandino@saludcastillayleon.es
-
Ledende efterforsker:
- Patricia Diezhandino Garcia, MD
-
-
Catalonia
-
Barcelona, Catalonia, Spanien, 08041
- Rekruttering
- Hospital de La Santa Creu i Sant Pau
-
Kontakt:
- Gemma Sancho Pardo, MD
- Telefonnummer: +34 935537756
- E-mail: gsancho@santpau.cat
-
Kontakt:
- Saudy Peláez Bonilla, Study coordinator
- Telefonnummer: 776 +34 935537760
- E-mail: SPelaez@santpau.cat
-
Underforsker:
- Arantxa Mera Errasti, MD
-
Ledende efterforsker:
- Gemma Sancho Pardo, MD
-
Underforsker:
- Laura Montezuma Niño, MD
-
Underforsker:
- Ana Maria Soto Cambres, MD
-
Terrassa, Catalonia, Spanien, 08227
- Aktiv, ikke rekrutterende
- Consorci Sanitari de Terrassa
-
-
Galicia
-
Santiago de Compostela, Galicia, Spanien, 15706
- Aktiv, ikke rekrutterende
- Complexo Hospitalario Universitario De Santiago
-
-
Madrid
-
Madrid, Madrid, Spanien, 28040
- Rekruttering
- Hospital Clinico San Carlos
-
Kontakt:
- Noelia Sanmamed, MD
- Telefonnummer: +34 985 10 80 00
- E-mail: noelia.sanmamed@salud.madrid.org
-
Ledende efterforsker:
- Noelia Sanmamed Salgado, MD
-
Underforsker:
- Manuel Gonzalo Vázquez Masedo, MD
-
Underforsker:
- Miren Gaztañaga Boronat, MD
-
Underforsker:
- Maria Nieves Cabrera Martin, MD
-
Underforsker:
- Natalia Vidal Cassinello, MD
-
Underforsker:
- Anxela Doval Gonzalez, MD
-
Underforsker:
- Javier Puente Vazquez, MD
-
Underforsker:
- Ignacio Moreno, MD
-
Madrid, Madrid, Spanien, 28034
- Aktiv, ikke rekrutterende
- Hospital Ramon y Cajal
-
-
Navarre
-
Pamplona, Navarre, Spanien, 31008
- Rekruttering
- Hospital Universitario de Navarra (HUN)
-
Ledende efterforsker:
- Marta Barrado Los Arcos, MD
-
Kontakt:
- Marta Barrado Los Arcos, MD
- Telefonnummer: +34 848 42 84 82
- E-mail: marta.barrado.losarcos@navarra.es
-
Underforsker:
- Amaya Sola Galarza, MD
-
Underforsker:
- Elena Villafranca Iturre, MD
-
Underforsker:
- Ignacio Visus Fernandez de Manzanos, MD
-
Underforsker:
- Nuria Bultó Boque, MD
-
Underforsker:
- Xabier Gurutzeaga Peleato, MD
-
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Principality of Asturias
-
Oviedo, Principality of Asturias, Spanien, 33011
- Aktiv, ikke rekrutterende
- Hospital Universitario Central de Asturias
-
-
Valencia
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Valencia, Valencia, Spanien, 46026
- Aktiv, ikke rekrutterende
- Hospital Universitario y Politécnico de La Fe
-
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Vizcaya
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Barakaldo, Vizcaya, Spanien, 48903
- Aktiv, ikke rekrutterende
- Hospital De Cruces
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 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 navne:
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marta Barrado Los Arcos, MD, Hospital of Navarra
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.
- 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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- Beer TM, Armstrong AJ, Rathkopf D, Loriot Y, Sternberg CN, Higano CS, Iversen P, Evans CP, Kim CS, Kimura G, Miller K, Saad F, Bjartell AS, Borre M, Mulders P, Tammela TL, Parli T, Sari S, van Os S, Theeuwes A, Tombal B. Enzalutamide in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study. Eur Urol. 2017 Feb;71(2):151-154. doi: 10.1016/j.eururo.2016.07.032. Epub 2016 Jul 28.
- Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.
- Uppal A, Ferguson MK, Posner MC, Hellman S, Khodarev NN, Weichselbaum RR. Towards a molecular basis of oligometastatic disease: potential role of micro-RNAs. Clin Exp Metastasis. 2014 Aug;31(6):735-48. doi: 10.1007/s10585-014-9664-3. Epub 2014 Jun 27.
- Haffner MC, Mosbruger T, Esopi DM, Fedor H, Heaphy CM, Walker DA, Adejola N, Gurel M, Hicks J, Meeker AK, Halushka MK, Simons JW, Isaacs WB, De Marzo AM, Nelson WG, Yegnasubramanian S. Tracking the clonal origin of lethal prostate cancer. J Clin Invest. 2013 Nov;123(11):4918-22. doi: 10.1172/JCI70354. Epub 2013 Oct 25.
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- Salama JK, Milano MT. Radical irradiation of extracranial oligometastases. J Clin Oncol. 2014 Sep 10;32(26):2902-12. doi: 10.1200/JCO.2014.55.9567. Epub 2014 Aug 11.
- Cardoso F, Harbeck N, Fallowfield L, Kyriakides S, Senkus E; ESMO Guidelines Working Group. Locally recurrent or metastatic breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012 Oct;23 Suppl 7:vii11-9. doi: 10.1093/annonc/mds232. No abstract available.
- Smith M, Parker C, Saad F, Miller K, Tombal B, Ng QS, Boegemann M, Matveev V, Piulats JM, Zucca LE, Karyakin O, Kimura G, Matsubara N, Nahas WC, Nole F, Rosenbaum E, Heidenreich A, Kakehi Y, Zhang A, Krissel H, Teufel M, Shen J, Wagner V, Higano C. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):408-419. doi: 10.1016/S1470-2045(18)30860-X. Epub 2019 Feb 6.
- Morris MJ, Heller G, Hillman DW, Bobek O, Ryan C, Antonarakis ES, Bryce AH, Hahn O, Beltran H, Armstrong AJ, Schwartz L, Lewis LD, Beumer JH, Langevin B, McGary EC, Mehan PT, Goldkorn A, Roth BJ, Xiao H, Watt C, Taplin ME, Halabi S, Small EJ. Randomized Phase III Study of Enzalutamide Compared With Enzalutamide Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer (Alliance A031201 Trial). J Clin Oncol. 2023 Jun 20;41(18):3352-3362. doi: 10.1200/JCO.22.02394. Epub 2023 Mar 30.
- Armstrong AJ, Lin P, Tombal B, Saad F, Higano CS, Joshua AM, Parli T, Rosbrook B, van Os S, Beer TM. Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial. Eur Urol. 2020 Sep;78(3):347-357. doi: 10.1016/j.eururo.2020.04.061. Epub 2020 Jun 9.
- Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, Shore ND, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Van Poppel H, Carles J, Flaig TW, Efstathiou E, Yu EY, Higano CS, Taplin ME, Griffin TW, Todd MB, Yu MK, Park YC, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ, Saad F. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol. 2014 Nov;66(5):815-25. doi: 10.1016/j.eururo.2014.02.056. Epub 2014 Mar 6.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. maj 2024
Primær færdiggørelse (Anslået)
16. maj 2030
Studieafslutning (Anslået)
16. maj 2030
Datoer for studieregistrering
Først indsendt
13. juli 2026
Først indsendt, der opfyldte QC-kriterier
16. juli 2026
Først opslået (Faktiske)
21. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Genitale neoplasmer, mandlige
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Kønssygdomme, mandlige
- Prostatasygdomme
- Mandlige urogenitale sygdomme
- Prostatiske neoplasmer
- Prostatiske neoplasmer, kastrationsresistente
- Polycykliske forbindelser
- Steroider
- SMUSED-RING-forbindelser
- Androstenes
- Androstanes
- Abirateronacetat
- Enzalutamid
Andre undersøgelses-id-numre
- IRA-RAD-2022-001
- 2023-505024-62 (EudraCT nummer)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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