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RECRUITING
NCT06772441
PHASE2

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

Sponsor: German Oncology Center, Cyprus

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-11-01

Completion Date

2027-10-31

Last Updated

2025-01-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

Androgen deprivation therapy (ADT)

* Goserelin: AstraZeneca, 10.8mg injection * ADT will be applied for 12 months in total * ADT must be given concurrently and adjuvant

Locations (1)

German Oncology Center

Limassol, Cyprus