OncoMatch/Clinical Trials/NCT07717268
Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients.
Is NCT07717268 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Xtandi and Zytiga® (Abiraterone Acetate) for prostatic neoplasms, castration-resistant.
Treatment: Xtandi · Zytiga® (Abiraterone Acetate) — 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 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 of life scale, EORTC QLQ-C30, validated for oncology patients. * Acute and chronic toxicity according to the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0) scale. This is a phase II, multicenter, prospective, single group study in patients with castrate-resistant prostate cancer (CRPC). Patients will be recruited at the participant sites, after study approval and hospital authorization. 51 patients will be included in the study. Eligible patients will require: * Choline PET/CT or 68Ga-PSMA PET/CT, dated no more than 8 weeks prior to inclusion. * Clinical history, physical examination and functional evaluation scale (ECOG). * Geriatric assessment scale for patients \> 75 years (modified G8 scale) * Toxicity scale assessment (CTCAEv5.0) * Baseline quality of life questionnaire (EORTC QLQ-C30) (47) * Blood tests with complete blood count, coagulation, liver function, renal function, ions, alkaline phosphatase, PSA and total and free testosterone, dated no more than 4 weeks prior inclusion. * Inclusion/exclusion criteria assessment * Second generation antiandrogen prescription, chosen by the responsible physician according to clinical practice, in each case. Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus). SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and/or exitus. Recruitment time is estimated at 36 months and a total follow-up time of 36 months. The total duration of the trial is therefore expected to be 6 years, to allow complete follow-up of the last patients included.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Demographics
Prior therapy
Must have received: second-generation antiandrogen (abiraterone, enzalutamide) — first-line treatment after a diagnosis of oligoresistance
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.
Cannot have received: docetaxel as first-line CRPC treatment (docetaxel)
Exception: previous docetaxel treatment is permitted when administered as hormone-sensitive metastatic prostate cancer treatment
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07717268 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior docetaxel as first-line CRPC treatment disqualifies patients from enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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