Condition: Prostatic Neoplasms, Castration-Resistant · Sponsor: Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
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 …
This description comes directly from the study's public registry record.
Pablo Raña Diez, PhD · +34 696633409 · investigacion@seor.es
Cristina Gutierrez Povedano, PhD · +34 675039150 · cristina.gutierrez.povedano@navarra.es
Always discuss trial participation with your own doctor first.
| Hospital Universitario Miguel Servet | Zaragoza, Aragon, Spain | Active Not Recruiting |
| Hospital Clinic de Barcelona | Barcelona, Barcelona, Spain | Recruiting |
| Instituto Catalán de Oncología Hospitalet | L'Hospitalet de Llobregat, Barcelona, Spain | Recruiting |
| Hospital Universitario Basurto | Bilbao, Basque Country, Spain | Active Not Recruiting |
| Hospital Universitario De Salamanca | Salamanca, Castille and León, Spain | Active Not Recruiting |
| Hospital Clínico Universitario De Valladolid | Valladolid, Castille and León, Spain | Recruiting |
| Hospital De La Santa Creu I Sant Pau | Barcelona, Catalonia, Spain | Recruiting |
| Consorci Sanitari De Terrassa | Terrassa, Catalonia, Spain | Active Not Recruiting |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela, Galicia, Spain | Active Not Recruiting |
| Hospital Ramón y Cajal | Madrid, Madrid, Spain | Active Not Recruiting |
| Hospital Clínico San Carlos | Madrid, Madrid, Spain | Recruiting |
| Hospital Universitario de Navarra (HUN) | Pamplona, Navarre, Spain | Recruiting |
+ 3 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07717268