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

RecruitingPhase 2Ages 18 Years - anyMaleGerman Oncology Center, Cyprus
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค15 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
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What it tests

  • Androgen Deprivation Therapy (ADT) - Goserelin
  • High-Dose-Rate Interstitial Brachytherapy (HDR BRT)
  • radiotherapy
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Where

1 site
German Oncology Center
Limassol, Cyprus
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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