Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With EPLNI
Recruiting
Phase 2
Interventional Study
Prostate Cancer Patients Treated by Radiotherapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Ain Shams University · Other
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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…
Trial Locations
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Eligibility Criteria
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 prost…
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