RecruitingPhase 2NCT06201078

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

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Enrollment

55 participants

Start Date

Jul 31, 2023

Study Type

INTERVENTIONAL

Conditions

Radiotherapy Local Recurrence of Malignant Tumor of Prostate

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

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a precise, focused form of radiation (stereotactic body radiotherapy, or SBRT) to treat prostate cancer that has come back in the same area after a patient previously received radiation therapy. **You may be eligible if...** - Your prostate cancer has come back locally (in or near the prostate) after your original radiation treatment - The recurrence has been confirmed by biopsy and/or MRI and PET scan - It has been at least 2 years since your original radiation treatment - You are in good general health (performance status 0–1) - The tumor is not too large (less than 14 mL in volume) **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or other parts of the body - You had severe side effects from your original radiation treatment - You have severe urinary problems before re-treatment (IPSS score of 19 or higher) - You have had prostate brachytherapy (internal radiation seeds) previously - You have significant rectal disease that could complicate re-irradiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Body Radiotherapy

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)

Maria Sklodowska Memorial Research Institute of Oncology

Gliwice, Poland

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NCT06201078

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