Taking people in SpainPhase 2
Radiotherapy plus hormone pill for prostate cancer that has spread to a few sites
Tests precise radiotherapy with an antiandrogen pill in adults with advanced prostate cancer.
Key facts
- Who runs it
- Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT)
- Where
- Barakaldo, Barcelona, Bilbao, L'Hospitalet de Llobregat, Madrid, Móstoles, Oviedo, Pamplona, Salamanca, Santiago de Compostela, Terrassa, Valencia, Valladolid, and Zaragoza, SpainSee the 16 sites
- Trial code
- Registry title
- Fractionated stereotactic radiotherapy plus second-generation antiandrogen for oligometastatic patients with castration-resistant prostate cancer. Phase II Spanish study, prospective, multicenter. (OLIGORESIST)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 51 people, planned
- Started
- 16 May 2024
- Expected to end
- 3 Jul 2028
- Type of study
- Interventional
- Record updated
- 16 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that no longer responds to hormone-lowering treatment and has spread to only a few places. They get radiotherapy to those spots plus abiraterone or enzalutamide.
- Age
- 18 years or older.
- Sex
- Men only.
- Disease stage
- Prostate adenocarcinoma confirmed by biopsy. Cancer is growing despite very low testosterone. It has spread to 5 or fewer lymph nodes or bones, with no organ spread. Bone spots must be under 3 cm (1.2 in) and lymph node spots under 5 cm (2 in).
- Earlier treatment
- Docetaxel as first treatment for castration-resistant disease is not allowed. Docetaxel given earlier, while the cancer still responded to hormone treatment, is allowed. The doctor must plan abiraterone or enzalutamide, or the person started it no more than 14 days before signing.
- Biomarker or test result
- Testosterone below 50 ng/ml (1.7 nmol/L). Growth shown by rising PSA (Phoenix criteria) or by a PSMA PET/CT or Choline PET/CT scan. Scan must show 5 or fewer spots.
Main reasons for not taking part
- Prostate cancer type other than adenocarcinoma
- No earlier biopsy
- More than 5 metastases that cannot be treated in 5 radiotherapy fields
- Spread to organs, or spots that cannot get this radiotherapy
- Testosterone above castration level
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Spain
- Hospital Universitario de CrucesBarakaldo, SpainTaking people
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital Universitario BasurtoBilbao, SpainTaking people
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainTaking people
- Hospital Clínico San CarlosMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario Rey Juan CarlosMóstoles, SpainTaking people
- Hospital Universitario Central De AsturiasOviedo, SpainTaking people
- Hospital Universitario de NavarraPamplona, SpainTaking people
- Hospital Universitario De SalamancaSalamanca, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
- Consorci Sanitari de TerrassaTerrassa, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
- Hospital Clínico Universitario de ValladolidValladolid, SpainTaking people
- Hospital Unviersitario Miguel ServetZaragoza, SpainTaking people
About the trial
What the trial wants to find out
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.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Fractionated stereotactic radiotherapy plus second-generation antiandrogen for oligometastatic patients with castration-resistant prostate cancer. Phase II Spanish study, prospective, multicenter. (OLIGORESIST)
- Plain-language title
- Radiotherapy plus hormone pill for prostate cancer that has spread to a few sitesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 16 April 2026