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
Maria Sklodowska-Curie National Research Institute of Oncology
55 participants
Jul 31, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria7
- 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 tolerability 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)
Interventions
Salvage SBRT will be performed in three subgroups of patients with local recurrence: Group A - after conventionally fractionated/moderately hypofractionated definitive radiotherapy; Group B - after prostatectomy and postoperative radiotherapy; Group C - after ultrahypofractionated definitive SBRT Target volumes: GTV- tumour visible on MRI and PET-CT; CTV- 1-3 mm margin around GTV PTV- 3 mm around CTV\* \*- in cases in which very high accuracy and reproducibility of SBRT are ensured, and the margin overlaps the rectum and/or bladder, it is possible to reduce the margin from these organs to 1 mm. Dose constrains: The criteria for limiting the dose in nearby organs are not well-defined for repeated irradiation - the following doses should be aimed: * Maximum rectal dose ≤103% of the prescribed dose (optimal ≤100%) * Maximum bladder dose ≤105% of the prescribed dose (optimal ≤103%) Dose-volume constrains: Rectum: • D30% \<15Gy Bladder: • D30% \< 15 Gy
Locations(1)
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NCT06201078