Personalizing prostate cancer treatment using artificial intelligence
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
This study is testing if using artificial intelligence to personalize radiation therapy can improve treatment outcomes for patients with high-risk localized prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | German Oncology Center, Cyprus Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Limassol) |
| Trial ID | NCT06582446 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to personalize radiation therapy (RT) for patients with high-risk localized prostate cancer by utilizing multimodal artificial intelligence (MMAI). Participants will receive standard care, which includes high-dose-rate brachytherapy, two years of androgen deprivation therapy (ADT), and ultra-hypofractionated RT. The study will assess the safety and effectiveness of this individualized approach compared to existing treatment protocols. Secondary endpoints will evaluate relapse-free survival, metastatic-free survival, prostate cancer survival, and overall survival.
Who should consider this trial
Good fit: Ideal candidates are men over 18 years old with histologically confirmed high-risk localized prostate cancer who meet specific imaging and performance criteria.
Not a fit: Patients with prior treatments for prostate cancer, evidence of pelvic nodal or distant metastatic disease, or certain advanced disease stages may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and tailored treatment options for patients with high-risk prostate cancer.
How similar studies have performed: While the use of AI in personalizing cancer treatment is an emerging field, similar studies have shown promise in improving treatment outcomes, although this specific approach remains novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Limassol
- German Oncology Center — Limassol, Cyprus (Recruiting)
Study contacts
- Principal investigator: Iosif Strouthos, MD — German Medical Institute
- Study coordinator: Elena Pallari, PhD
- Email: elena.pallari@goc.com.cy
- Phone: 0035725028690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.