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New treatment option for Local Recurrence of Malignant Tumor of Prostate
Official title Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy
ClinicalTrials.gov ID: NCT06201078
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- 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)
You likely can't join if
- Polymetastatic dissemination in distant or regional lymph nodes (N1, M1) or oligometastatic dissemination, but not eligible for local forms of...
- Tumour volume (GTV) \> 14 cc
- Poor side effects of primary radiotherapy (≥G3 toxicity) or persistent late toxicity ≥G2 interfering with re-irradiation
- Severe dysuria before repeated SBRT (e.g., IPSS ≥19)
- Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure)
- Previous prostate brachytherapy
See the full eligibility criteria
- 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...
- Polymetastatic dissemination in distant or regional lymph nodes (N1, M1) or oligometastatic dissemination, but not eligible for local forms of metastasis directed therapy (MDT)
- Tumour volume (GTV) \> 14 cc
- Poor side effects of primary radiotherapy (≥G3 toxicity) or persistent late toxicity ≥G2 interfering with re-irradiation
- Severe dysuria before repeated SBRT (e.g., IPSS ≥19)
- Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure)
- Previous prostate brachytherapy
- Substantial risk for further urologic interventions (e.g., TURB/TURP)
The study team makes the final eligibility decision.
Where it's taking place
- Gliwice, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gliwice, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.