RecruitingPhase 2NCT06772441

Artificial Intelligence Driven Personalisation of Radiotherapy and Concomitant Androgen Deprivation Therapy for Prostate Cancer Patients (the HypoPro Trial)

Prostate-only, Dose-escalated Radiotherapy Plus Concomitant Androgen Deprivation Therapy in Primary Localized, NCCN High Risk and MMAI Classifier Low or Intermediate-risk Prostate Cancer - a Prospective, Single-arm, Phase II Study

Sponsor

German Oncology Center, Cyprus

Enrollment

30 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

The aim of this prospective, single-arm phase II study is the individualization of both radiotherapy (RT) and androgen deprivation therapy (ADT) duration for patients with high-risk localized prostate cancer (PCa) according to the National Comprehensive Cancer Network (NCCN) based on multimodal artificial intelligence (MMAI) classification. All patients will receive (i) a dose escalation to the prostate via HDR brachytherapy (boost), (ii) twelve months of ADT and (iii) extremely hypofractionated RT to the prostate (5 fractions). This way, patients in the HypoPro trial will receive a prostate-only dose escalation and benefit from shortening of the ADT compared with current guideline recommendations.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called HypoPro) is using artificial intelligence to personalize radiation therapy and hormone-blocking treatment (androgen deprivation therapy) for men with high-risk prostate cancer, aiming to make treatment more precise and effective while reducing side effects. **You may be eligible if...** - You have been diagnosed with prostate cancer confirmed by biopsy - Your cancer is classified as high-risk (Stage cT3a or higher, high-grade, or PSA above 20) - You have not yet received radiation therapy or surgery for your prostate cancer - There is no evidence of lymph node involvement or distant spread **You may NOT be eligible if...** - You previously received radiotherapy to the prostate or pelvis - You previously had a radical prostatectomy (surgical prostate removal) - You previously had focal therapy (e.g., cryotherapy or HIFU) to the prostate - There is evidence of cancer spread to lymph nodes or distant organs - The timing between hormone therapy and imaging is more than 2 months 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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