Re-irradiation for local prostate cancer recurrences
Phase II Study - Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy - PROSTARE (PROstate Cancer STereotActic REirradiation) Trial
This study is testing if a special type of radiation therapy can safely help men whose prostate cancer has come back after previous treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology Academic / other |
| Locations | 1 site (Gliwice) |
| Trial ID | NCT06201078 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and effectiveness of stereotactic body radiotherapy (SBRT) for patients experiencing local recurrence of prostate cancer after prior radiotherapy. The study focuses on assessing the incidence of toxicity, particularly genitourinary and gastrointestinal side effects, while also measuring various efficacy endpoints such as biochemical control and overall survival. Patients will be categorized into subgroups based on their previous treatment types, and their quality of life will be monitored throughout the study. The aim is to determine if SBRT can serve as a viable salvage treatment option with a favorable toxicity profile.
Who should consider this trial
Good fit: Ideal candidates are men with biopsy-proven local recurrence of prostate cancer at least two years after definitive radiotherapy and a good performance status.
Not a fit: Patients with distant metastases or significant pre-existing toxicity from prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for patients with recurrent prostate cancer.
How similar studies have performed: Previous studies have indicated that stereotactic radiotherapy has a favorable toxicity profile, suggesting potential success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Gliwice
- Maria Sklodowska Memorial Research Institute of Oncology — Gliwice, Poland (Recruiting)
Study contacts
- Principal investigator: Wojciech Majewski, MD, PhD — Maria Sklodowska Curie Memorial Research Institute of Oncology
- Study coordinator: Wojciech Majewski, MD, PhD
- Email: wojciech.majewski@gliwice.nio.gov.pl
- Phone: +48322788001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.