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Fractionated stereotactic radiotherapy plus second-generation antiandrogen for oligometastatic patients with castration-resistant prostate cancer. Phase II Spanish study, prospective, multicenter. (OLIGORESIST)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505024-62-01
Acronym
IRA-RAD-2022-001
Enrollment
51
Registered
2023-10-09
Start date
2024-05-16
Completion date
Unknown
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oligometastatic patients with castration-resistant prostate cancer

Brief summary

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.

Detailed description

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 QLQ-C30, validated for oncology patients. of life scale, EORTC ., Acute and chronic toxicity according to the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0) scale.

Interventions

DRUGAbiraterona Normon 500 mg comprimidos revestidos por película
DRUGXtandi - 80 mg film-coated tablets

Sponsors

Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT)
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 QLQ-C30, validated for oncology patients. of life scale, EORTC ., Acute and chronic toxicity according to the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0) scale.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026