Fractionated stereotactic radiotherapy plus second-generation antiandrogen for oligometastatic patients with castration-resistant prostate cancer. Phase II Spanish study, prospective, multicenter. (OLIGORESIST)
Key facts
- Where
- Barakaldo, Barcelona, Bilbao, L'Hospitalet de Llobregat, Madrid, Móstoles, Oviedo, Pamplona, Salamanca, Santiago de Compostela, Terrassa, Valencia, Valladolid és Zaragoza, SpanyolországSee the 16 sites
- Phase
- 2. fázis
Where in Spanyolország
- Hospital Universitario de CrucesBarakaldo, SpanyolországTaking people
- Hospital Clinic de BarcelonaBarcelona, SpanyolországTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországTaking people
- Hospital Universitario BasurtoBilbao, SpanyolországTaking people
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpanyolországTaking people
- Hospital Clínico San CarlosMadrid, SpanyolországTaking people
- Hospital Universitario Ramón y CajalMadrid, SpanyolországTaking people
- Hospital Universitario Rey Juan CarlosMóstoles, SpanyolországTaking people
- Hospital Universitario Central De AsturiasOviedo, SpanyolországTaking people
- Hospital Universitario de NavarraPamplona, SpanyolországTaking people
- Hospital Universitario De SalamancaSalamanca, SpanyolországTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpanyolországTaking people
- Consorci Sanitari de TerrassaTerrassa, SpanyolországTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországTaking people
- Hospital Clínico Universitario de ValladolidValladolid, SpanyolországTaking people
- Hospital Unviersitario Miguel ServetZaragoza, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT)
- Trial code
- EU 2023-505024-62-01
- Record updated
- 2026. április 16.
- Original description
Determine the PRFS measured from the time of initiation of secondgeneration 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.Read full original descriptionShow less
Determine the PRFS measured from the time of initiation of secondgeneration 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.
Inclusion: 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); Radiological confirmation (with choline-PET/CT or 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: No previous biopsy; 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; Patients with prostate carcinoma with histology other than adenocarcinoma; > 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.