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Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With EPLNI (SIB-VMAT)

3. juli 2026 opdateret af: Mohamed Alhefny Almashtouly, Ain Shams University

Prospective Evaluation of Efficacy and Safety of Simultaneous Integrated Boost (SIB-VMAT) Radiotherapy in HR/VHR Prostate Cancer With EPLNI

The aim of this study is to evaluate the efficacy and safety of hypofractionated simultaneous integrated boost volumetric arc radiation therapy (SIB - VMAT) for high-risk and very high-risk localized prostate cancer in terms of:

  1. Acute and late gastrointestinal and genitourinary toxicities.
  2. Evaluate the efficacy in terms of early bPFS.
  3. Dosimetric evaluation in terms of target coverage and organs at risk sparing

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Background:

Despite the overwhelming success of hypofractionation for prostate-only radiotherapy, a substantial gap in high-level evidence exists regarding its application to elective pelvic lymph node irradiation. The pivotal trials establishing the 60 Gy/20 fraction standard (such as CHHiP and PROFIT) largely excluded extensive whole pelvic nodal irradiation. Consequently, there remains a lack of definitive, prospective data validating the safety and efficacy of a hypofractionated Simultaneous Integrated Boost (SIB) technique that concurrently delivers 44 Gy to the pelvic lymph nodes and 60 Gy to the prostate over 20 fractions. While modern image-guided, Volumetric Modulated Arc Therapy (VMAT) provides the dosimetric conformity required to spare organs at risk (OARs) such as the bladder and bowel, clinical confirmation of acute and late toxicities in the context of wide-field pelvic irradiation remains paramount.

Therefore, this prospective, single-arm trial is designed to address this critical evidence gap. By rigorously evaluating the GI and GU toxicity profiles and early biochemical control, this study seeks to validate the 4-week SIB protocol as a safe, efficacious, and resource-efficient standard of care for high-risk prostate cancer requiring elective pelvic nodal irradiation.

Objectives:

To evaluate the safety of hypofractionated SIB - VMAT radiation therapy in terms of acute and late GI and GU toxicities, and also evaluate the efficacy in terms of early bPFS, and lastly, dosimetric evaluation in terms of target coverage and OAR sparing Study Arms Single arm Population: Histologically confirmed localized prostatic adenocarcinoma with high and very high risk groups.

Primary Endpoint: Acute and late GIT & GU toxicities (according to CTCAE & RTOG).

Secondary Endpoints:

  1. To evaluate early biochemical control (serum PSA) at 6 and 12 months.
  2. To perform a dosimetric analysis of target coverage and of organs at risk (OARs) dose contains.

Significance α = 0.05 two-sided; power = 80%; minimum detectable HR = 0.65 Duration 12 months total (from IRB approval to submission of the manuscript).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 2

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Egypten
      • Cairo, Egypten
        • Rekruttering
        • Faculty of Medicine, Ain Shams University
        • Kontakt:
      • Shibīn al Kawm, Egypten
        • Rekruttering
        • Faculty of Medicine - Menoufia University
        • Kontakt:
      • Sohag, Egypten
        • Rekruttering
        • Faculty of Medicine - Sohag University
        • Kontakt:

Deltagelseskriterier

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  • Voksen
  • Ældre voksen

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Beskrivelse

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate.
  • Classification as High-Risk (HR) or Very High-Risk (VHR) per NCCN guidelines (e.g., T3a+, PSA > 20 ng/mL, or Gleason Score 8-10).
  • Adequate baseline urinary function (IPSS \le 20).
  • Multiparametric MRI of the prostate.
  • CT Chest, Abdomen, and Pelvis.
  • Bone scan
  • Optional: PSMA-PET/CT to definitively exclude distant metastases (M1) and provide high-fidelity nodal assessment prior to treatment planning.

Exclusion Criteria:

  • Prior pelvic radiotherapy.
  • History of Inflammatory Bowel Disease (IBD) or active severe proctitis.
  • Presence of distant metastases.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SIB-VMAT radiation therapy

Patients with histopathologically confirmed prostatic adenocarcinoma staged as high-risk / very high-risk localized disease will receive radiotherapy using Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT) over a total duration of 4 weeks (20 consecutive working days).

Target volumes:

PTV-1 (PTV 44 Gy) Prostate + Pelvic Lymph Node PTV (PLNI): 44 Gy delivered in 20 fractions (2.2 Gy/fraction), including the internal iliac, external iliac, obturator, presacral nodal stations, whole prostate, and SV.

PTV-2 (PTV 60 GY): 60 Gy delivered in 20 fractions (3 Gy/fraction), including the whole prostate and the base of the SV (proximal 1 cm).

Systemic Therapy is allowed during the study when indicated. Patients will receive long-term Androgen Deprivation Therapy (ADT) for a duration of 18-24 months. ADT will be initiated as neoadjuvant therapy 2-3 months prior to the commencement of radiotherapy.
Stråling: Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT)
Patients with histopathologically confirmed prostatic adenocarcinoma staged as high-risk / very high-risk localized disease will receive radiotherapy using Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT) over a total duration of 4 weeks (20 consecutive working days). Target volumes: PTV-1 (PTV 44 Gy) Prostate + Pelvic Lymph Node PTV (PLNI): 44 Gy delivered in 20 fractions (2.2 Gy/fraction), including the internal iliac, external iliac, obturator, presacral nodal stations, whole prostate, and SV. PTV-2 (PTV 60 GY): 60 Gy delivered in 20 fractions (3 Gy/fraction), including the whole prostate and the base of the SV (proximal 1 cm). Systemic Therapy is allowed during the study when indicated. Patients will receive long-term Androgen Deprivation Therapy (ADT) for a duration of 18-24 months. ADT will be initiated as neoadjuvant therapy 2-3 months prior to the commencement of radiotherapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute and late GIT & GU toxicity
Tidsramme: Day 1, Day 7, Day 14, Day 20 from radiation therapy start, then week 4, week 8, week 12 from radiation therapy end.
The incidence and severity of acute (during the radiation treatment and up to 3 months post-treatment) and late (after 3 months from finishing radiotherapy) gastrointestinal (GI) and genitourinary (GU) toxicities associated with the SIB-VMAT approach using CTCAE v5.0 and RTOG scale.
Day 1, Day 7, Day 14, Day 20 from radiation therapy start, then week 4, week 8, week 12 from radiation therapy end.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Early biochemical progression-free survival (bPFS)
Tidsramme: Day 1, Month 3, Month 6 and Month 12, from radiation therapy end.
Early biochemical control in terms of the serial measurement of serum PSA levels.
Day 1, Month 3, Month 6 and Month 12, from radiation therapy end.
Dosimetric plan evaluation
Tidsramme: Baseline (Day 1 of radiation therapy start).
  1. Dosimetric analysis of planning target volume coverage (PTV ): at least 95% of the volume must be covered with 95% of the prescribed radiation dose.
  2. Dosimetric analysis of organs at risk (OAR) dose constraints, including rectum, urinary bladder, bowel, femoral heads, and penile bulb radiation doses, according to Quantec and Chipp trial dose constraints.
Baseline (Day 1 of radiation therapy start).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ain Shams University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2025

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. november 2026

Datoer for studieregistrering

Først indsendt

28. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Soh-Med-26-6-12PD

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Kliniske forsøg med Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT)

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