Actively Recruiting
Artificial Intelligence Driven Personalisation of Radiotherapy and Concomitant Androgen Deprivation Therapy for Prostate Cancer Patients (the HypoPro Trial)
Led by German Oncology Center, Cyprus · Updated on 2025-01-13
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
G
German Oncology Center, Cyprus
Lead Sponsor
A
Artera
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this prospective, single-arm phase II study is the individualization of both radiotherapy (RT) and androgen deprivation therapy (ADT) duration for patients with high-risk localized prostate cancer (PCa) according to the National Comprehensive Cancer Network (NCCN) based on multimodal artificial intelligence (MMAI) classification. All patients will receive (i) a dose escalation to the prostate via HDR brachytherapy (boost), (ii) twelve months of ADT and (iii) extremely hypofractionated RT to the prostate (5 fractions). This way, patients in the HypoPro trial will receive a prostate-only dose escalation and benefit from shortening of the ADT compared with current guideline recommendations.
CONDITIONS
Official Title
Artificial Intelligence Driven Personalisation of Radiotherapy and Concomitant Androgen Deprivation Therapy for Prostate Cancer Patients (the HypoPro Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate (re-biopsy if biopsy older than 12 months should be considered)
- Primary prostate cancer confirmed by PSMA-PET imaging and multiparametric MRI
- High-risk prostate cancer per NCCNv4.2023 criteria (cT3a or Grade group 4-5 or PSA > 20 ng/ml)
- Signed written informed consent for the study
- Age greater than 18 years
- Previous PSMA-PET/CT, multiparametric MRI or PSMA-PET/MR imaging done
- Classified as MMAI low- or intermediate-risk
- ECOG performance status 0 or 1
- IPSS score 15 or less
- Prostate biopsy core with highest ISUP grade available
You will not qualify if you...
- Prior radiotherapy to the prostate or pelvis
- Prior radical prostatectomy
- Prior focal therapy to the prostate
- Evidence of pelvic nodal disease (cN+) on mpMRI or PSMA-PET/CT
- Evidence of distant metastatic disease (cM+) on mpMRI or PSMA-PET/CT
- More than 2 months gap between starting systemic therapy or ADT and PSMA-PET scans
- Evidence of cT4 disease on mpMRI or PSMA-PET/CT
- PSA greater than 50 ng/ml before starting systemic therapy
- Expected survival less than 5 years
- Bilateral hip prostheses or implants causing significant CT artifacts
- Contraindications to MRI or HDR brachytherapy
- Contraindications to Goserelin
- Significant prostate surgery cavity or surgery within 6 months before randomization
- Medical conditions making radiotherapy inadvisable (e.g., acute inflammatory bowel disease, hemiplegia, paraplegia)
- Previous malignancy within 2 years except certain skin cancers or if it affects 5-year survival
- Contraindications to external beam radiotherapy to pelvis
- Participation in other interventional clinical trials within 30 days prior
- Simultaneous participation in interfering interventional trials
- Lack of legal capacity to understand the trial
- Known or persistent substance abuse
- Expected severe setup problems such as mental condition
AI-Screening
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Trial Site Locations
Total: 1 location
1
German Oncology Center
Limassol, Cyprus, 4108
Actively Recruiting
Research Team
E
Elena Pallari, PhD
CONTACT
K
Kristis Vevis, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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