Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy
Recruiting
Phase 2
Interventional Study
Local Recurrence of Malignant Tumor of Prostate
Radiotherapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 55 (estimated)
- Sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology · Other
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About This 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…
Trial Locations
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Eligibility 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 o…
Contacts