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

Recruiting now · Phase 2

Conditions studied: Prostatic Neoplasms, Castration-Resistant

In brief

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.

Key facts

Study ID: NCT07717268
Run by: Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
People needed: 51
Starts: 2024-05-16
Expected to finish: 2030-05-16
Last updated by the study team: 2026-07-21

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

Hospital Clínico Universitario De Valladolid — Valladolid, Castille and León, Spain (enrolling)
Hospital Clínico San Carlos — Madrid, Madrid, Spain (enrolling)
Hospital Universitario de Navarra (HUN) — Pamplona, Navarre, Spain (enrolling)
Hospital De La Santa Creu I Sant Pau — Barcelona, Catalonia, Spain (enrolling)
Hospital Clinic de Barcelona — Barcelona, Barcelona, Spain (enrolling)
Instituto Catalán de Oncología Hospitalet — L'Hospitalet de Llobregat, Barcelona, Spain (enrolling)
Hospital Universitario Central De Asturias — Oviedo, Principality of Asturias, Spain
Hospital Universitario y Politécnico de La Fe — Valencia, Valencia, Spain
Hospital Universitario Miguel Servet — Zaragoza, Aragon, Spain
Hospital de Cruces — Barakaldo, Vizcaya, Spain
Hospital Universitario Basurto — Bilbao, Basque Country, Spain
Hospital Universitario De Salamanca — Salamanca, Castille and León, Spain
Consorci Sanitari De Terrassa — Terrassa, Catalonia, Spain
Complexo Hospitalario Universitario De Santiago — Santiago de Compostela, Galicia, Spain
Hospital Ramón y Cajal — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.