Actively Recruiting
Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy
Led by Maria Sklodowska-Curie National Research Institute of Oncology · Updated on 2025-03-13
55
Participants Needed
1
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 conventionally fractionated/moderately hypofractionated definitive radiotherapy (Group A) or ultrahypofractionated definitive SBRT (Group C) or after prostatectomy and post-operative radiotherapy (Group B). The study group is planned to include 55 patients.
CONDITIONS
Official Title
Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with local recurrence of prostate cancer after definitive radiotherapy
- Recurrence confirmed by biopsy and/or consistent MRI and PET-PSMA results with PSA growth
- At least 2 years elapsed since primary radiotherapy
- Good performance status (ZUBROD 0-1)
- Repeated imaging if MRI and PET-PSMA results are inconsistent and biopsy is not possible
You will not qualify if you...
- Polymetastatic or ineligible oligometastatic dissemination
- Tumor volume larger than 14 cc
- Poor tolerability of primary radiotherapy with 63 toxicity or persistent late toxicity 62 affecting re-irradiation
- Severe urinary symptoms before SBRT (e.g., IPSS 6519)
- Diseases affecting distal rectum or anal canal that may reduce SBRT tolerance
- Previous prostate brachytherapy
- High risk for further urologic surgeries like TURB or TURP
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maria Sklodowska Memorial Research Institute of Oncology
Gliwice, Poland, 44-100
Actively Recruiting
Research Team
W
Wojciech Majewski, MD, PhD
CONTACT
A
Aleksandra Napieralska, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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