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Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy

RecruitingPhase 2Ages 18 Years - 80 YearsMaleMaria Sklodowska-Curie National Research Institut…
NCT06201078 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical study is to evaluate the toxicity and efficacy of re-irradiation using focal stereotactic body radiotherapy (SBRT) in patients with local recurrence of prostate cancer after definitive or post-operative radiotherapy. The main question is the tolerance of such treatment, concerning the incidence of Grade ≥ 2 and Grade ≥ 3 GU and GI toxicity. Also the efficacy of SBRT will be measured in terms of Biochemical Control with other secondary endpoints which include: Biochemical Response, Biochemical Failure-Free Survival, Metastases-Free Survival, Relapse-Free Survial, Local Control, Overall Survival and patients' reported tolerance measured with Quality of Life questionnaires (QoL C-30 and PR-25). The evaluation of the tolerance and effectiveness of stereotactic radiotherapy (SBRT) will be performed in 3 subgroups: in patients with local recurrence after conventiona

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Local recurrence of prostate cancer after definitive radiotherapy 1. biopsy proven or/and 2. Consistent MRI and PET-PSMA results and PSA growth dynamics 2. Time since primary radiotherapy - at least 2 years 3. Good performance status (ZUBROD 0-1) * If the results of the MRI and PET PSMA are inconsistent, and if there is no technical possibility of performing an MRI biopsy, the treatment is acceptable, but repeated imaging (PET or MRI) should be performed to assess the dynamics of the recurrence. Exclusion Criteria: 1. Polymetastatic dissemination in distant or regional lymph nodes (N1, M1) or oligometastatic dissemination, but not eligible for local forms of metastasis directed therapy (MDT) 2. Tumour volume (GTV) \> 14 cc 3. Poor tolerability of primary radiotherapy (≥G3 toxicity) or persistent late toxicity ≥G2 interfering with re-irradiation 4. Severe dysuria before repeated SBRT (e.g., IPSS ≥19) 5. Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure) 6. Previous prostate brachytherapy 7. Substantial risk for further urologic interventions (e.g., TURB/TURP)
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What it tests

  • Stereotactic Body Radiotherapy
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Where

1 site
Maria Sklodowska Memorial Research Institute of Oncology
Gliwice, Poland
🤝 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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