The aim of this prospective, single-arm phase II study is the individualization of both radiotherapy (RT) and androgen deprivation therapy (ADT) duration for patients with high-risk localized prostate cancer (PCa) according to the National Comprehensive Cancer Network (NCCN) based on multimodal artificial intelligence (MMAI) classification. All patients will receive (i) a dose escalation to the prostate via HDR brachytherapy (boost), (ii) twelve months of ADT and (iii) extremely hypofractionated RT to the prostate (5 fractions).
This way, patients in the HypoPro trial will receive a prostate-only dose escalation and benefit from shortening of the ADT compared with current guideline recommendations.
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
Prior radiotherapy to the prostate or pelvis
Prior radical prostatectomy
Prior focal therapy approaches to the prostate
Evidence of pelvic nodal disease (cN+) in mpMRI and/or PSMA-PET/CT
Single group
Androgen deprivation therapy (ADT)
Drug* Goserelin: AstraZeneca, 10.8mg injection * ADT will be applied for 12 months in total * ADT must be given concurrently and adjuvant
Disease-free survival 5 years after treatment
Disease recurrence is defined as PSA failure according to Phoenix, new lesions on PSMA PET and/or MRI imaging or the beginning of any salvage therapy.
Time to local or regional failure, after end of RT
Local or regional recurrences have to be confirmed by PSMA-PET or mpMR imaging. For the diagnosis of local failure, verification via biopsy is warranted
Metastatic free survival (MFS) after end of RT
MFS is defined as survival time in months from beginning of RT until detection of any new lesion confirmed as metastasis by PSMA-PET/CT or mpMR imaging or death.
Overall survival (OS)
OS will be measured from the last day of RT to the date of death whatever the cause of death is. Patients who are alive are censored at the date of the most recent follow-up examination. The cause of death of each patient dying during the study will be recorded and reported.
Prostate cancer specific survival (PCSS)
PCSS is defined from the last day of RT until death as most reasonable consequence of progressive prostate cancer, judged by the investigator.
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German Oncology Center, Cyprus
Lead sponsor
Artera
Collaborator