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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up Men only

Personalized radiotherapy and hormone therapy for prostate cancer

Official title: 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

Run by German Oncology Center, Cyprus · NCT06772441 · Data updated 2026-11-12

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

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment30 (estimated)
SponsorGerman Oncology Center, Cyprus
Academic / other
Drugs / interventionsradiation
Locations1 site (Limassol)
StatusRecruiting
StartedNovember 1, 2024
Main results expectedOctober 31, 2026
Study endsOctober 31, 2027
Registry record updatedSeptember 15, 2026
Trial IDNCT06772441 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men over 18 with histologically confirmed high-risk localized prostate cancer who meet specific imaging and performance criteria.

Probably not a fit

Patients with prior prostate or pelvic radiotherapy, radical prostatectomy, or evidence of metastatic disease will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While similar approaches have been explored, this specific use of multimodal artificial intelligence for treatment personalization in prostate cancer is relatively novel.

Who can join: the full rules

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 it's running

  • German Oncology Center
    Limassol, Cyprus     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Prostate Cancer 1464German Oncology Center, Cyprus 3
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.