NCT06582446RecruitingPhase 2
Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)
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
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 31 Jul 2024
- Start date
- 16 Sept 2024
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- German Oncology Center, Cyprus
- Diseases
- Prostate cancer
- NCT number
- NCT06582446
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 16 Sept 2024 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Age
- Expected patient survival \<5 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| German Oncology Center Coordinator of this site? Confirm its status | Limassol | Cyprus | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.