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Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients.

RecruitingPhase 2Ages any - anyMaleInstituto de Investigación en Oncología Radioterá…
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In plain words

What the trial is, and whether it could suit you

The objectives of the study are to analyze the results obtained in survival, safety and quality of life after the combination of SBRT plus second-generation antiandrogen in patients diagnosed with metastatic castration-resistant prostate cancer in oligometastasis (≤5). Hence, the investigators evaluate the results of the combination of two widely used treatments in prostate cancer: SBRT plus the 'standard of care' for patients with mCRPC, second-generation antiandrogens (abiraterone and enzalutamide). Primary objective: Determine the PRFS measured from the time of initiation of second-generation 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. Secondary objectives: * Overall survival (time from initiation of second-generation antiandrogen to exit

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Xtandi
  • Zytiga® (Abiraterone Acetate)
  • SBRT
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Where

15 sites
Hospital Universitario Miguel Servet
Zaragoza, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Instituto Catalán de Oncología Hospitalet
L'Hospitalet de Llobregat, Spain
Hospital Universitario Basurto
Bilbao, Spain
Hospital Universitario De Salamanca
Salamanca, Spain
Hospital Clínico Universitario De Valladolid
Valladolid, Spain
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
Consorci Sanitari De Terrassa
Terrassa, Spain

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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