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

Recruiting now · Phase 2

Conditions studied: Prostate Cancer

In brief

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).

Key facts

Study ID

NCT06582446

Run by

German Oncology Center, Cyprus

People needed

30

Starts

2024-09-16

Expected to finish

2027-08-31

Last updated by the study team

2025-03-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Age >18 years
• Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR
• MMAI high-risk
• ECOG Performance score 0 or 1
• IPSS Score ≤15

You may not qualify if…

• 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
• Evidence of distant metastatic disease (cM+) in mpMRI and/or PSMA-PET/CT
• Time gap between the beginning of any systemic therapyADT and conduction of PSMA-PET scans is >2 months
• Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT
• PSA >50 ng/ml prior to starting of systemic therapy
• Expected patient survival <5 years
• Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
• Contraindication to undergo a MRI scan
• Contraindication to undergo HDR brachytherapy (brachytherapy not feasible due to large prostate volume, prostate anatomy, tumor in distant seminal vesicles and/or unfit for anesthesia)
• Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization
• Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia
• Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival
• Any other contraindication to external beam radiotherapy (EBRT) to the pelvis
• Participation in any other interventional clinical trial within the last 30 days before the start of this trial
• Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
• Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
• Known or persistent abuse of medication, drugs or alcohol

Where it is running

• German Oncology Center — Limassol, Cyprus (enrolling)

Full record on ClinicalTrials.gov

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