Status:
RECRUITING
Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
Local Recurrence of Malignant Tumor of Prostate
Radiotherapy
Eligibility:
MALE
18-80 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
The diagnosis of local recurrence after radiotherapy in patients with prostate cancer is a serious clinical problem. Interventional salvage treatment in the previously irradiated area is difficult wit...
Eligibility Criteria
Inclusion
- Local recurrence of prostate cancer after definitive radiotherapy
- biopsy proven or/and
- Consistent MRI and PET-PSMA results and PSA growth dynamics
- Time since primary radiotherapy - at least 2 years
- 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
- Polymetastatic dissemination in distant or regional lymph nodes (N1, M1) or oligometastatic dissemination, but not eligible for local forms of metastasis directed therapy (MDT)
- Tumour volume (GTV) \> 14 cc
- Poor tolerability of primary radiotherapy (≥G3 toxicity) or persistent late toxicity ≥G2 interfering with re-irradiation
- Severe dysuria before repeated SBRT (e.g., IPSS ≥19)
- Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure)
- Previous prostate brachytherapy
- Substantial risk for further urologic interventions (e.g., TURB/TURP)
Key Trial Info
Start Date :
July 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06201078
Start Date
July 31 2023
End Date
December 31 2029
Last Update
March 13 2025
Active Locations (1)
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1
Maria Sklodowska Memorial Research Institute of Oncology
Gliwice, Poland, 44-100