2023-505024-62-01RecruitingPhase 2
Fractionated stereotactic radiotherapy plus second-generation antiandrogen for oligometastatic patients with castration-resistant prostate cancer. Phase II Spanish study, prospective, multicenter. (OLIGORESIST)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- First submitted
- 5 Sept 2023
- Start date
- 16 May 2024
- Lead sponsor
- Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT)
- Diseases
- Prostate cancer
- EU CT number
- 2023-505024-62-01
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 51
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de Cruces | Barakaldo | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital Universitario Basurto | Bilbao | Spain | Recruiting |
| Institut Catala D'oncologia | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos | Madrid | Spain | Recruiting |
| Hospital Universitario Rey Juan Carlos | Móstoles | Spain | Recruiting |
| Hospital Universitario Central De Asturias | Oviedo | Spain | Recruiting |
| Hospital Universitario de Navarra | Pamplona | Spain | Recruiting |
| Hospital Universitario De Salamanca | Salamanca | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela | Spain | Recruiting |
| Consorci Sanitari de Terrassa | Terrassa | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Recruiting |
| Hospital Clínico Universitario de Valladolid | Valladolid | Spain | Recruiting |
| Hospital Unviersitario Miguel Servet | Zaragoza | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.