Re-irradiation for local prostate cancer recurrences

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.