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

Launched by GERMAN ONCOLOGY CENTER, CYPRUS · Jan 8, 2025

Keywords

ClinConnect Summary

The HypoPro Trial is a clinical study designed to explore a new approach to treating high-risk localized prostate cancer. The main goal is to personalize the treatment for each patient using advanced artificial intelligence. Participants in this trial will receive a specific type of radiotherapy focused on the prostate along with hormone therapy for one year, but with a shorter duration than what is typically recommended. This approach aims to improve treatment outcomes while reducing the therapy time for patients.

To be eligible for the trial, participants must be men aged 18 and older with confirmed prostate cancer that meets certain high-risk criteria, such as specific tumor characteristics or PSA levels. They should not have undergone previous radiation or surgery for prostate cancer and must be in good overall health. If you join the trial, you can expect to receive targeted treatment tailored to your situation, along with regular monitoring and support throughout the study. It's an exciting opportunity to potentially benefit from cutting-edge research in prostate cancer management!

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. 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)
• • 2. Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI)
• • 3. High-risk according to NCCNv4.2023 criteria (cT3a or Grade group 4-5 or PSA \> 20 ng/ml)
• • 4. Signed written informed consent for this study
• • 5. Age \>18 years
• • 6. Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR
• • 7. MMAI low-/intermediate-risk
• • 8. ECOG Performance score 0 or 1
• • 9. IPSS Score ≤15
• • 10. Prostate biopsy core with the highest ISUP grade available
• Exclusion Criteria:
• • 1. Prior radiotherapy to the prostate or pelvis
• • 2. Prior radical prostatectomy
• • 3. Prior focal therapy approaches to the prostate
• • 4. Evidence of pelvic nodal disease (cN+) in mpMRI and/or PSMA-PET/CT
• • 5. Evidence of distant metastatic disease (cM+) in mpMRI and/or PSMA-PET/CT
• • 6. Time gap between the beginning of any systemic therapy, ADT and conduction of PSMA-PET scans is \>2 months
• • 7. Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT
• • 8. PSA \>50 ng/ml prior to starting of systemic therapy
• • 9. Expected patient survival \<5 years
• • 10. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
• • 11. Contraindication to undergo a MRI scan
• • 12. Contraindication to undergo HDR brachytherapy (brachytherapy not feasible due to large prostate volume, prostate anatomy, tumor in distant seminal vesicles and/or unfit for anaesthesia)
• • 13. Contraindication to Goserelin
• • 14. Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization
• • 15. Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia
• • 16. 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
• • 17. Any other contraindication to external beam radiotherapy (EBRT) to the pelvis
• • 18. Participation in any other interventional clinical trial within the last 30 days before the start of this trial
• • 19. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
• • 20. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;
• • 21. Known or persistent abuse of medication, drugs or alcohol
• • 22. Patients expected to have severe set up problems (e.g. mental condition)