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Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy

Study acronym: PROSTARE
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary endpoints: 2 to 1v5 Show 4 more changesShow less
    • Enrollment target: 60 to 55
    • Eligibility criteria revised
    • Secondary endpoints: 6 to 9
    • Study description expanded, about 2 words
  2. Secondary endpoints: 5 to 6v4
  3. Secondary endpoints: details revised at 3 of 5 entries
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 3 words
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06201078
Lead Sponsor Maria Sklodowska-Curie National Research Institute of Oncology
Conditions
(from sponsor)		 Local Recurrence of Malignant Tumor of Prostate, Radiotherapy
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov