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

Image-guided Focal Dose Escalation in Patients With Primary Prostate Cancer Treated With Primary External Beam Hypofractionated Stereotactic Radiation Therapy (HypoFocal-SBRT) - a Prospective, Multicenter, Randomized Phase III Study

This study is testing a new way to give radiation treatment for prostate cancer that focuses more on the tumor and less on healthy tissue to see if it works better than the usual method.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 374 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University Hospital Freiburg (other)
• Drugs / interventions: radiation
• Locations: 1 site (Freiburg im Breisgau, Baden-Wurttemberg)
• Trial ID: NCT06330909 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include men over 18 with histologically confirmed localized prostate cancer, particularly those classified as high-risk or unfavorable intermediate-risk.

Not a fit: Patients with prior treatments such as radiotherapy or radical prostatectomy, or those with neuroendocrine tumors, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved tumor control and a better quality of life for patients with prostate cancer.

How similar studies have performed: Other studies have shown promising results with similar imaging-guided approaches in radiotherapy, indicating potential for success in this novel application.

Eligibility 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 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 this trial is running

Freiburg im Breisgau, Baden-Wurttemberg

• Medical Center - University of Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany (RECRUITING)

Study contacts

• Study coordinator: Sabine Schneider-Fuchs, DR

Conditions: Prostate Cancer, HypoFocal, HypoFocal-SBRT