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Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With EPLNI

ConditionProstate Cancer Patients Treated by Radiotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Prior pelvic radiotherapy.

History of Inflammatory Bowel Disease (IBD) or active severe proctitis.

Presence of distant metastases.

Trial design

Design model

Single group

Treatments tested in this trial

  • Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT)

    Radiation

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: SIB-VMAT radiation therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Acute and late GIT & GU toxicity

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.

Time frame
Day 1, Day 7, Day 14, Day 20 from radiation therapy start, then week 4, week 8, week 12 from radiation therapy end.

Secondary outcomes

1

Early biochemical progression-free survival (bPFS)

Early biochemical control in terms of the serial measurement of serum PSA levels.

Time frame
Day 1, Month 3, Month 6 and Month 12, from radiation therapy end.
2

Dosimetric plan evaluation

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.

Time frame
Baseline (Day 1 of radiation therapy start).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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