Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofract.Stereotactic rt

Korábbi kezelés

• Prior radiotherapy to the prostate or pelvis
• Prior radical prostatectomy
• Prior focal therapy approaches to the prostate
• PSA >30 ng/ml prior to starting ADT
• Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts
• 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

Más betegség

• Evidence of metastatic disease (cM+) in mpMRI and/or PSMA PET/CT
• Evidence of cT4 disease in mpMRI 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

Életkor

• Expected patient survival <5 years

Egyéb

• Evidence of neuroendocrine tumor cells
• Time gap between the beginning of ADT and conduction of mpMRI and PSMA PET scans is >1 month
• Radiologically suspicious or pathologically confirmed lymph node involvement (cN+) in mpMRI and/or PSMA PET/CT
• Contraindication to undergo a mpMRI scan
• In mpMRI and PSMA PET/CT or PSMA PET/MRI scans no visible tumor
• 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;
• Patients expected to have severe set up problems
• Dose constraints for organs at risk cannot be adhered to

• 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 localized PCa (cN0 and cM0 in mpMRI and PSMA PET):
  • high- or very high-risk according to NCCN v2.2021 (see 20.3) OR
  • unfavorable intermediate-risk disease according to NCCN v2.2021 (see 20.3)
• Signed, written informed consent for HypoFocal-SBRT study
• Age > 18 years
• Previously conducted PSMA-PET/CT and mpMRI scans or PSMA-PET/MR, fulfilling standard requirements for PCa (see also 6.5)
• ECOG Performance score 0 or 1
• IPSS Score ≤15
• Prostate volume ≤75 ml at RT planning