Status:
RECRUITING
Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)
Lead Sponsor:
German Oncology Center, Cyprus
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 curr...
Detailed Description
Prostate cancer (PCa) is the most frequent diagnosed malignancy in male patients in Europe and radiation therapy (RT) is a main treatment option. For primary high-risk localized PCa patients, NCCNv4.2...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06582446
Start Date
September 16 2024
End Date
August 31 2027
Last Update
March 11 2025
Active Locations (1)
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1
German Oncology Center
Limassol, Cyprus, 4108