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

NCT06201078 · tracked via the Priya Life Science Poland tracker

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Phase

Phase 2

Started

2023-07-31

Last updated

2025-03-13

Condition(s) studied

Local Recurrence of Malignant Tumor of ProstateRadiotherapy

Investigational drug(s) / intervention(s)

Stereotactic Body Radiotherapy

Stereotactic 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

Study 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

MALE

Min age

18 Years

Max age

80 Years

Healthy volunteers

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 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 Criteria: 1. Polymetastatic dissemination in distant or regional lymph nodes (N1, M1) or oligometastatic dissemination, but not eligible for local forms of metastasis directed therapy (MDT) 2. Tumour volume (GTV) \> 14 cc 3. Poor tolerability of primary radiotherapy (≥G3 toxicity) or persistent late toxicity ≥G2 interfering with re-irradiation 4. Severe dysuria before repeated SBRT (e.g., IPSS ≥19) 5. Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure) 6. Previous prostate brachytherapy 7. Substantial risk for further urologic interventions (e.g., TURB/TURP)

Primary outcome measure(s)

Tolerance of salvage SBRT — 3 months post-SBRT, 2-years post-SBRT
Assessment of early and late radiation toxicity: Grade ≥ 3 radiation-induced bladder/urethral (GU) and bowel/rectal (GI) adverse events toxicity or other, according to CTCAE criteria

Trial sites (1)

Facility	City	Region	Status
Maria Sklodowska Memorial Research Institute of Oncology	Gliwice	Poland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06201078 on ClinicalTrials.gov ↗ ← All trials in Poland