Focal dose escalation for prostate cancer using advanced imaging and radiotherapy techniques

Is this trial a fit for you?

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

What this trial studies

This clinical trial aims to personalize radiotherapy for patients with primary prostate cancer by utilizing advanced imaging techniques such as multiparametric MRI and PSMA-PET/CT. The study compares two treatment approaches: one that escalates the radiation dose to the intraprostatic tumor mass while minimizing exposure to surrounding organs, and a control group receiving standard treatment. By employing ultra-hypofractionated stereotactic body radiation therapy, the trial seeks to reduce treatment time and improve tumor control. The study is prospective, randomized, and multicenter, involving multiple locations to gather diverse patient data.

Why it matters

Who can join: the full rules

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 localized PCa (cN0 and cM0 in mpMRI and PSMA PET):

   * high- or very high-risk according to NCCN v2.2021 (see 20.3) OR
   * unfavorable intermediate-risk disease according to NCCN v2.2021 (see 20.3)
3. Signed, written informed consent for HypoFocal-SBRT study
4. Age \> 18 years
5. Previously conducted PSMA-PET/CT and mpMRI scans or PSMA-PET/MR, fulfilling standard requirements for PCa (see also 6.5)
6. ECOG Performance score 0 or 1
7. IPSS Score ≤15
8. Prostate volume ≤75 ml at RT planning

Exclusion Criteria:

1. Evidence of neuroendocrine tumor cells
2. Prior radiotherapy to the prostate or pelvis
3. Prior radical prostatectomy
4. Prior focal therapy approaches to the prostate
5. Time gap between the beginning of ADT and conduction of mpMRI and PSMA PET scans is \>1 month
6. Radiologically suspicious or pathologically confirmed lymph node involvement (cN+) in mpMRI and/or PSMA PET/CT
7. Evidence of metastatic disease (cM+) in mpMRI and/or PSMA PET/CT
8. Evidence of cT4 disease in mpMRI or PSMA PET/CT
9. PSA \>30 ng/ml prior to starting ADT
10. Expected patient survival \<5 years
11. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts
12. Contraindication to undergo a mpMRI scan
13. Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization
14. Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia
15. 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
16. Any other contraindication to external beam radiotherapy (EBRT) to the pelvis
17. In mpMRI and PSMA PET/CT or PSMA PET/MRI scans no visible tumor
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
23. Dose constraints for organs at risk cannot be adhered to

Where it's running

• Medical Center - University of Freiburg
  Freiburg im Breisgau, Baden-Wurttemberg, Germany Recruiting

Study contacts

• Study coordinator: Sabine Schneider-Fuchs, DR
• Email: sabine.schneider-fuchs@uniklinik-freiburg.de
• Phone: +4976127074040

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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.