Actively Recruiting
Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)
Led by German Oncology Center, Cyprus · Updated on 2025-03-11
30
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate
- Primary prostate cancer confirmed by PSMA-PET imaging and multiparametric MRI
- High- or very high-risk prostate cancer according to NCCN version 1.2023 criteria
- Signed written informed consent to participate in the study
- Age greater than 18 years
- Prior PSMA-PET/CT, multiparametric MRI, or PSMA-PET/MR performed
- Classified as high-risk by multimodal artificial intelligence (MMAI)
- ECOG performance status of 0 or 1
- International Prostate Symptom Score (IPSS) of 15 or less
You will not qualify if you...
- Prior radiation therapy to the prostate or pelvis
- Prior radical prostatectomy
- Prior focal therapy to the prostate
- Evidence of pelvic lymph node involvement (cN+) on MRI or PSMA-PET/CT
- Evidence of distant metastases (cM+) on MRI or PSMA-PET/CT
- Time between starting systemic therapy (ADT) and PSMA-PET scan greater than 2 months
- Presence of cT4 disease on MRI or PSMA-PET/CT
- Prostate-specific antigen (PSA) greater than 50 ng/ml before systemic therapy
- Expected survival less than 5 years
- Bilateral hip prostheses or other implants causing substantial CT artifacts
- Contraindications to MRI
- Contraindications to HDR brachytherapy due to prostate size, anatomy, tumor location, or anesthesia risk
- Significant tissue cavity from prior prostate surgery (TURP or HOLEP) or surgery within 6 months before randomization
- Medical conditions making radiotherapy inadvisable (e.g. acute inflammatory bowel disease, hemiplegia, paraplegia)
- Previous malignancy within 2 years except certain skin cancers or if it would affect 5-year survival
- Contraindications to external beam radiotherapy (EBRT) to the pelvis
- Participation in other interventional clinical trials within 30 days before this trial
- Simultaneous participation in interventional trials that interfere with this study
- Lack of legal capacity to understand the trial
- Known or persistent abuse of medication, drugs, or alcohol
AI-Screening
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Trial Site Locations
Total: 1 location
1
German Oncology Center
Limassol, Cyprus, 4108
Actively Recruiting
Research Team
E
Elena Pallari, PhD
CONTACT
K
Kristis Vevis, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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