Personalized radiotherapy and hormone therapy for prostate cancer
Prostate-only, Dose-escalated Radiotherapy Plus Concomitant Androgen Deprivation Therapy in Primary Localized, NCCN High Risk and MMAI Classifier Low or Intermediate-risk Prostate Cancer - a Prospective, Single-arm, Phase II Study
This study is testing a personalized treatment plan that combines targeted radiation and hormone therapy for men with high-risk prostate cancer to see if it helps them stay cancer-free longer than standard treatments.
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 | NCT06772441 on ClinicalTrials.gov |
What this trial studies
This phase II trial aims to personalize radiotherapy and the duration of androgen deprivation therapy (ADT) for patients with high-risk localized prostate cancer using multimodal artificial intelligence classification. Participants will receive high-dose-rate brachytherapy followed by stereotactic body radiation therapy, along with 12 months of ADT. The study seeks to evaluate the efficacy of this individualized approach compared to standard treatment protocols, focusing on disease-free survival and other oncologic outcomes.
Who should consider this trial
Good fit: Ideal candidates include men over 18 with histologically confirmed high-risk localized prostate cancer who meet specific imaging and performance criteria.
Not a fit: Patients with prior prostate or pelvic radiotherapy, radical prostatectomy, or evidence of metastatic disease will 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 similar approaches have been explored, this specific use of multimodal artificial intelligence for treatment personalization in prostate cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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) 2. Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI) 3. High-risk according to NCCNv4.2023 criteria (cT3a or Grade group 4-5 or PSA \> 20 ng/ml) 4. Signed written informed consent for this study 5. Age \>18 years 6. Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR 7. MMAI low-/intermediate-risk 8. ECOG Performance score 0 or 1 9. IPSS Score ≤15 10. Prostate biopsy core with the highest ISUP grade available Exclusion Criteria: 1. Prior radiotherapy to the prostate or pelvis 2. Prior radical prostatectomy 3. Prior focal therapy approaches to the prostate 4. Evidence of pelvic nodal disease (cN+) in mpMRI and/or PSMA-PET/CT 5. Evidence of distant metastatic disease (cM+) in mpMRI and/or PSMA-PET/CT 6. Time gap between the beginning of any systemic therapy, ADT and conduction of PSMA-PET scans is \>2 months 7. Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT 8. PSA \>50 ng/ml prior to starting of systemic therapy 9. Expected patient survival \<5 years 10. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts 11. Contraindication to undergo a MRI scan 12. Contraindication to undergo HDR brachytherapy (brachytherapy not feasible due to large prostate volume, prostate anatomy, tumor in distant seminal vesicles and/or unfit for anaesthesia) 13. Contraindication to Goserelin 14. Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization 15. Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia 16. 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 17. Any other contraindication to external beam radiotherapy (EBRT) to the pelvis 18. Participation in any other interventional clinical trial within the last 30 days before the start of this trial 19. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed 20. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial; 21. Known or persistent abuse of medication, drugs or alcohol 22. Patients expected to have severe set up problems (e.g. mental condition)
Where this trial is running
Limassol
- German Oncology Center — Limassol, Cyprus (Recruiting)
Study contacts
- Study coordinator: Elena Pallari, PhD
- Email: elena.pallari@goc.com.cy
- Phone: +357 25028690
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.