Tests focal stereotactic radiotherapy for prostate cancer that has returned after radiotherapy
Tests focal stereotactic radiation again in men whose prostate cancer returned locally.
Plain-language title generated from the registry record
Registry title: Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy
Key facts
- Where
- Gliwice, PolandSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06201078, who can take part
Where in Poland
- Maria Sklodowska Memorial Research Institute of OncologyGliwice, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Maria Sklodowska-Curie National Research Institute of Oncology
- Trial code
- NCT06201078
- Record updated
- 13 March 2025
- Original description
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.Read full original descriptionShow less
Phase II Study - Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy - PROSTARE (PROstate Cancer STereotActic REirradiation) Trial
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.
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); Poor tolerability of primary radiotherapy (≥G3 toxicity) or persistent late toxicity ≥G2 interfering with re-irradiation; Previous prostate brachytherapy; Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure); Tumour volume (GTV) > 14 cc; Severe dysuria before repeated SBRT (e.g., IPSS ≥19); Substantial risk for further urologic interventions (e.g., TURB/TURP).