Health Trials

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

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorGerman Oncology Center, Cyprus

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old)

Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI)

High- or very high-risk according to NCCNv1.2023 criteria

Signed written informed consent for this study

Disqualifiers

Prior radiotherapy to the prostate or pelvis

Prior radical prostatectomy

Prior focal therapy approaches to the prostate

Evidence of pelvic nodal disease (cN+) in mpMRI and/or PSMA-PET/CT

Trial design

Design model

Single group

Treatments tested in this trial

  • Androgen Deprivation Therapy (ADT) - Goserelin

    Drug

    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

  • High-Dose-Rate Interstitial Brachytherapy (HDR BRT)

    Radiation

    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.)

  • radiotherapy

    Radiation

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Single experimental armExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

cumulative GU toxicity

Primary endpoint is cumulative GU toxicity according to RTOG grading after minimum FU time of two years.

Time frame
two years

Secondary outcomes

1

Time to local or regional failure

Time to local or regional failure; after end of RT. Local or regional recurrences have to be confirmed by PSMA-PET or mpMR imaging. For the diagnosis of local failure a verification via biopsy is warranted.

Time frame
two and five years after RT
2

MMAI classifier

Prognostic influence of MMAI classifier for outcome; the ArteraAI Prostate Test score (ranging from 0.0 to 1.0)

Time frame
5-year and 10-year risk prediction of distant metastasis and 10-year risk of prostate-specific mortality.
3

Testosterone

Testosterone recovery is to be done through blood test

Time frame
assessment at 6,9,12,18 and 24 months after randomization (± 14 days for each visit) and at 30, 36, 42, 48, 54, 60 months after Ultra-hypofractionated RT - UHF (± 1 month
4

Metastatic free survival (MFS)

MFS after end of RT, (all metastases have to be confirmed by PSMA-PET/CT or mpMR imaging)

Time frame
two and five years after RT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

German Oncology Center, Cyprus

Lead sponsor

Source ClinicalTrials.gov
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