Table 1.

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 localized PCa (cN0 and cM0 in mpMRI and PSMA-PET): high- or very high-risk according to NCCN v2.2021 OR unfavorable intermediate-risk disease according to NCCN v2.2021

Signed written informed consent for this study

Age > 18 years

Previously conducted PSMA-PET/CT and mpMRI scans or PSMA-PET/MR for staging, fulfilling standard requirements for PCa

ECOG performance score 0 or 1

IPSS score ≤ 15

Prostate volume ≤ 75 mL at RT planning

Exclusion criteria:

Evidence of neuroendocrine tumor cells

Prior radiotherapy to the prostate or pelvis

Prior radical prostatectomy

Prior focal therapy approaches to the prostate

Time gap between the beginning of ADT and conduction of initial mpMRI and PSMA-PET scans is >1 month

Radiologically suspicious or pathologically confirmed lymph node involvement (cN+) in mpMRI and/or PSMA-PET/CT

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

Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT

PSA > 30 ng/mL prior to starting ADT

Expected patient survival <5 years

Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts

Contraindication to undergo a mpMRI scan

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

In mpMRI and PSMA-PET/CT or PSMA-PET/MRI scans, no visible tumor

Participation in any other interventional clinical trial within the last 30 days before the start of this trial

Simultaneous participation in other interventional trials that 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

Patients expected to have severe set up problems

Dose constraints for organs at risk cannot be adhered to