Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)

Summary

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).

Eligibility

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 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 Criteria:

* 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
* Evidence of distant metastatic disease (cM+) in mpMRI and/or PSMA-PET/CT
* Time gap between the beginning of any systemic therapyADT and conduction of PSMA-PET scans is \>2 months
* Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT
* PSA \>50 ng/ml prior to starting of systemic therapy
* Expected patient survival \<5 years
* Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
* 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)
* 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
* Participation in any other interventional clinical trial within the last 30 days before the start of this trial
* 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
* Known or persistent abuse of medication, drugs or alcohol

Conditions2

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