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

Ki vehet részt

• 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-risk according to NCCNv4.2023 criteria (cT3a or Grade group 4-5 or PSA > 20 ng/ml)
• Signed written informed consent for this study
• Age >18 years
• Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR
• MMAI low-/intermediate-risk
• ECOG Performance score 0 or 1
• IPSS Score ≤15
• Prostate biopsy core with the highest ISUP grade available

Ki nem vehet részt

• Prior radiotherapy to the prostate or pelvis
• Prior radical prostatectomy
• Prior focal therapy approaches to the prostate
• Time gap between the beginning of any systemic therapy, ADT and conduction of PSMA-PET scans is >2 months
• PSA >50 ng/ml prior to starting of systemic therapy
• Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
• Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization
• 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
• Known or persistent abuse of medication, drugs or alcohol
• 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
• Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT
• 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
• Patients expected to have severe set up problems (e.g. mental condition)
• Expected patient survival <5 years
• 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 anaesthesia)
• Contraindication to Goserelin
• 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