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

Launched by GERMAN ONCOLOGY CENTER, CYPRUS · Aug 30, 2024

Keywords

ClinConnect Summary

The HypoElect Trial is a clinical study designed to explore how artificial intelligence can help personalize treatment for men with high-risk prostate cancer. In this trial, all participants will receive standard treatments that include a specific type of radiation therapy directed at the prostate, hormone therapy for two years, and radiation treatment for the entire pelvic area. This study aims to see if using advanced technology can make these treatments more effective for individuals based on their unique cancer characteristics.

To be eligible for this trial, participants must be adult males aged 18 and older who have a confirmed diagnosis of prostate cancer that is considered high-risk. They should have undergone certain imaging tests recently, and must be able to provide written consent to join the study. However, those with a history of specific prior treatments, significant health issues, or other factors that could complicate receiving radiation therapy will not be eligible. Participants can expect to receive comprehensive care and be closely monitored throughout the study, contributing valuable information that may improve future treatment options for prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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