Fractionated Stereotactic Radiotherapy Plus Second-Generation Antiandrogen in oligometastatic castration-resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional study evaluating the combination of SBRT with a second-generation antiandrogen (abiraterone or enzalutamide) in men with metastatic castration-resistant prostate cancer and up to five metastases. Primary endpoint is progression-free survival based on radiologic progression from starting antiandrogen to progression on PET imaging. Secondary endpoints include overall survival and safety/quality of life data. Eligible patients have histologically confirmed prostate adenocarcinoma, castration-level testosterone, and limited non-visceral metastases suitable for SBRT. Treatments are delivered at multiple centers in Spain, involving Instituto de Investigación en Oncología Radioterápica and collaborating institutions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Clinic de Barcelona
  Barcelona, Barcelona, Spain Recruiting
• Instituto Catalán de Oncología Hospitalet
  L'Hospitalet de Llobregat, Barcelona, Spain Recruiting
• Hospital Clínico Universitario De Valladolid
  Valladolid, Castille and León, Spain Recruiting
• Hospital De La Santa Creu I Sant Pau
  Barcelona, Catalonia, Spain Recruiting
• Hospital Clínico San Carlos
  Madrid, Madrid, Spain Recruiting
• Hospital Universitario de Navarra (HUN)
  Pamplona, Navarre, Spain Recruiting

Study contacts

• Principal investigator: Marta Barrado Los Arcos, MD — Hospital of Navarra
• Study coordinator: Pablo Raña Diez, PhD
• Email: investigacion@seor.es
• Phone: +34 696633409

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.