NCT06201078RecruitingPhase 2
Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy
Phase II Study - Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy - PROSTARE (PROstate Cancer STereotActic REirradiation) Trial
Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 29 Dec 2023
- Start date
- 31 Jul 2023
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Diseases
- Prostate cancer
- NCT number
- NCT06201078
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 55
- From 31 Jul 2023 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure)
Other
- Tumour volume (GTV) \> 14 cc
- Severe dysuria before repeated SBRT (e.g., IPSS ≥19)
- Substantial risk for further urologic interventions (e.g., TURB/TURP)
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maria Sklodowska Memorial Research Institute of Oncology Coordinator of this site? Confirm its status | Gliwice | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.