Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)
Recruiting · NCT06582446 · Interventional (participants receive a specific treatment) · Lead sponsor: German Oncology Center, Cyprus
View the official record on ClinicalTrials.gov →Interventions studied
Androgen Deprivation Therapy (ADT) - GoserelinHigh-Dose-Rate Interstitial Brachytherapy (HDR BRT)radiotherapy
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- German Oncology Center - Limassol, Cyprus