Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients. (OLIGORESIST)
16 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Stato
Reclutamento
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Stimato)
Iscrizione
51
Fase
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: Pablo Raña Diez, PhD
- Numero di telefono: +34 696633409
- Email: investigacion@seor.es
Backup dei contatti dello studio
- Nome: Cristina Gutierrez Povedano, PhD
- Numero di telefono: +34 675039150
- Email: cristina.gutierrez.povedano@navarra.es
Luoghi di studio
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Aragon
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Zaragoza, Aragon, Spagna, 50009
- Attivo, non reclutante
- Hospital Universitario Miguel Servet
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Barcelona
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Barcelona, Barcelona, Spagna, 08036
- Reclutamento
- Hospital Clinic de Barcelona
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Contatto:
- Joel Mases, MD
- Email: mases@clinic.cat
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Investigatore principale:
- Joel Mases i Rosinés, MD
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Sub-investigatore:
- Elías Gomís, MD
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Sub-investigatore:
- Sara Moreno, MD
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Sub-investigatore:
- Gerard Meca, MD
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L'Hospitalet de Llobregat, Barcelona, Spagna, 08908
- Reclutamento
- Instituto Catalán de Oncología Hospitalet
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Contatto:
- Anna Maria Boladeras, MD
- Email: aboladeras@iconcologia.net
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Investigatore principale:
- Ana María Boladeras Inglada, MD
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Basque Country
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Bilbao, Basque Country, Spagna, 48013
- Attivo, non reclutante
- Hospital Universitario Basurto
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Castille and León
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Salamanca, Castille and León, Spagna, 37007
- Attivo, non reclutante
- Hospital Universitario De Salamanca
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Valladolid, Castille and León, Spagna, 47003
- Reclutamento
- Hospital Clínico Universitario de Valladolid
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Contatto:
- Patricia Diezhandino Garcia, MD
- Numero di telefono: +34 983 420 003
- Email: pdiezhandino@saludcastillayleon.es
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Investigatore principale:
- Patricia Diezhandino Garcia, MD
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Catalonia
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Barcelona, Catalonia, Spagna, 08041
- Reclutamento
- Hospital de La Santa Creu i Sant Pau
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Contatto:
- Gemma Sancho Pardo, MD
- Numero di telefono: +34 935537756
- Email: gsancho@santpau.cat
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Contatto:
- Saudy Peláez Bonilla, Study coordinator
- Numero di telefono: 776 +34 935537760
- Email: SPelaez@santpau.cat
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Sub-investigatore:
- Arantxa Mera Errasti, MD
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Investigatore principale:
- Gemma Sancho Pardo, MD
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Sub-investigatore:
- Laura Montezuma Niño, MD
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Sub-investigatore:
- Ana Maria Soto Cambres, MD
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Terrassa, Catalonia, Spagna, 08227
- Attivo, non reclutante
- Consorci Sanitari de Terrassa
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Galicia
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Santiago de Compostela, Galicia, Spagna, 15706
- Attivo, non reclutante
- Complexo Hospitalario Universitario De Santiago
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Madrid
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Madrid, Madrid, Spagna, 28040
- Reclutamento
- Hospital Clinico San Carlos
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Contatto:
- Noelia Sanmamed, MD
- Numero di telefono: +34 985 10 80 00
- Email: noelia.sanmamed@salud.madrid.org
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Investigatore principale:
- Noelia Sanmamed Salgado, MD
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Sub-investigatore:
- Manuel Gonzalo Vázquez Masedo, MD
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Sub-investigatore:
- Miren Gaztañaga Boronat, MD
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Sub-investigatore:
- Maria Nieves Cabrera Martin, MD
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Sub-investigatore:
- Natalia Vidal Cassinello, MD
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Sub-investigatore:
- Anxela Doval Gonzalez, MD
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Sub-investigatore:
- Javier Puente Vazquez, MD
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Sub-investigatore:
- Ignacio Moreno, MD
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Madrid, Madrid, Spagna, 28034
- Attivo, non reclutante
- Hospital Ramon y Cajal
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Navarre
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Pamplona, Navarre, Spagna, 31008
- Reclutamento
- Hospital Universitario de Navarra (HUN)
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Investigatore principale:
- Marta Barrado Los Arcos, MD
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Contatto:
- Marta Barrado Los Arcos, MD
- Numero di telefono: +34 848 42 84 82
- Email: marta.barrado.losarcos@navarra.es
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Sub-investigatore:
- Amaya Sola Galarza, MD
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Sub-investigatore:
- Elena Villafranca Iturre, MD
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Sub-investigatore:
- Ignacio Visus Fernandez de Manzanos, MD
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Sub-investigatore:
- Nuria Bultó Boque, MD
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Sub-investigatore:
- Xabier Gurutzeaga Peleato, MD
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Principality of Asturias
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Oviedo, Principality of Asturias, Spagna, 33011
- Attivo, non reclutante
- Hospital Universitario Central de Asturias
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Valencia
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Valencia, Valencia, Spagna, 46026
- Attivo, non reclutante
- Hospital Universitario y Politécnico de La Fe
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Vizcaya
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Barakaldo, Vizcaya, Spagna, 48903
- Attivo, non reclutante
- Hospital De Cruces
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
1
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Altro: 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)
Altri nomi:
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Determine the PRFS
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Marta Barrado Los Arcos, MD, Hospital of Navarra
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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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.
- Iyengar P, Kavanagh BD, Wardak Z, Smith I, Ahn C, Gerber DE, Dowell J, Hughes R, Abdulrahman R, Camidge DR, Gaspar LE, Doebele RC, Bunn PA, Choy H, Timmerman R. Phase II trial of stereotactic body radiation therapy combined with erlotinib for patients with limited but progressive metastatic non-small-cell lung cancer. J Clin Oncol. 2014 Dec 1;32(34):3824-30. doi: 10.1200/JCO.2014.56.7412. Epub 2014 Oct 27.
- Cox BW, Spratt DE, Lovelock M, Bilsky MH, Lis E, Ryu S, Sheehan J, Gerszten PC, Chang E, Gibbs I, Soltys S, Sahgal A, Deasy J, Flickinger J, Quader M, Mindea S, Yamada Y. International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):e597-605. doi: 10.1016/j.ijrobp.2012.03.009. Epub 2012 May 19.
- Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. doi: 10.1056/NEJMoa1207506. Epub 2012 Aug 15.
- 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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- 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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- 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.
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- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
16 maggio 2024
Completamento primario (Stimato)
Completamento primario
16 maggio 2030
Completamento dello studio (Stimato)
Completamento dello studio
16 maggio 2030
Date di iscrizione allo studio
Primo inviato
Primo inviato
13 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
16 luglio 2026
Primo Inserito (Effettivo)
Primo Inserito
21 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
21 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 luglio 2026
Ultimo verificato
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Neoplasie genitali, maschio
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie genitali, maschio
- Malattie della prostata
- Malattie urogenitali maschili
- Neoplasie prostatiche
- Neoplasie prostatiche resistenti alla castrazione
- Composti policiclici
- Steroidi
- Composti anelli fusi
- Androstenes
- Androstanes
- Acetato di Abiraterone
- Enzalutamide
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- IRA-RAD-2022-001
- 2023-505024-62 (Numero EudraCT)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .