RecruitingPhase 2NCT06582446

Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)

Whole-pelvis Hypofractionated Radiotherapy Combined With Dose-escalation to the Prostate and Androgen Deprivation Therapy in Primary Localized, NCCN and MMAI High-risk Prostate Cancer - a Prospective, Single-arm, Phase II Study

Sponsor

German Oncology Center, Cyprus

Enrollment

30 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

A prospective, single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on multimodal artificial intelligence (MMAI). All patients will receive the current standard of care: (i) a dose escalation to the prostate via HDR brachytherapy, (ii) two years of ADT and (iii) whole-pelvis UHF-RT (5 fractions).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial uses artificial intelligence to help personalize radiation therapy for men with high-risk prostate cancer. Rather than a standard radiation schedule, the AI analyzes each patient's cancer characteristics to recommend a tailored hypofractionated approach — fewer, higher-dose radiation sessions — that may be more effective and convenient. **You may be eligible if...** - You have prostate cancer confirmed by biopsy - Your cancer is classified as high-risk or very high-risk according to national guidelines - Your cancer is localized (not spread to distant sites based on advanced imaging) - You have signed consent and can attend treatment at the participating center **You may NOT be eligible if...** - You have prostate cancer that has spread to lymph nodes or other organs - You have had prior pelvic radiation therapy - You have had a prior radical prostatectomy 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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Interventions

DRUGAndrogen Deprivation Therapy (ADT) - Goserelin

The patients under ADT and the patients who will receive the ADT during the study will be included in the trial. * ADT will be applied for 24 months in total * ADT must be given concurrently and adjuvant

RADIATIONHigh-Dose-Rate Interstitial Brachytherapy (HDR BRT)

HDR BRT Procedure will be performed using transperineal catheter implantation under transrectal US-guidance performed under anesthesia, spinal or general with patient in high lithotomy position.)

RADIATIONradiotherapy

EBRT prostate + elective pelvis (Ultra-hypofractionated): 25 Gy in 5 Gy per fraction