Tests radiation with hormone therapy in men with high-risk prostate cancer

Trial details

Who runs it

German Oncology Center, Cyprus

Trial code

NCT06582446

Record updated

17 September 2026

Original description

A prospective, single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on multimodal artificial intelligence (MMAI). All patients will receive the current standard of care: (i) a dose escalation to the prostate via HDR brachytherapy, (ii) two years of ADT and (iii) whole-pelvis UHF-RT (5 fractions).Read full original descriptionShow less

Whole-pelvis Hypofractionated Radiotherapy Combined With Dose-escalation to the Prostate and Androgen Deprivation Therapy in Primary Localized, NCCN and MMAI High-risk Prostate Cancer - a Prospective, Single-arm, Phase II Study

A prospective, single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on multimodal artificial intelligence (MMAI). All patients will receive the current standard of care: (i) a dose escalation to the prostate via HDR brachytherapy, (ii) two years of ADT and (iii) whole-pelvis UHF-RT (5 fractions).

Inclusion: 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: Prior radiotherapy to the prostate or pelvis; Prior radical prostatectomy; Prior focal therapy approaches to the prostate; 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; Expected patient survival <5 years; Time gap between the beginning of any systemic therapyADT and conduction of PSMA-PET scans is >2 months; 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); 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.

ClinicalTrials.gov NCT06582446