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

NCT06582446 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-11

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Androgen 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

RADIATION

High-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.)

RADIATION

radiotherapy

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

Sponsors & Collaborators

  • German Oncology Center, Cyprus

    lead OTHER

Principal Investigators

  • Iosif Strouthos, MD · German Medical Institute

  • Constantinos Zamboglou, MD · German Medical Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-16
Primary Completion
2026-08-31
Completion
2027-08-31

Countries

  • Cyprus

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06582446 on ClinicalTrials.gov