Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofract.Stereotactic rt

Launched by UNIVERSITY HOSPITAL FREIBURG · Mar 19, 2024

Keywords

ClinConnect Summary

The HypoFocal-SBRT study is a clinical trial focused on improving treatment for men with localized prostate cancer. This trial is exploring a new way of delivering radiation therapy that combines advanced imaging techniques with a method called ultra-hypofractionated radiotherapy. This approach aims to deliver higher doses of radiation to the tumor while reducing the overall treatment time. Researchers believe that this method could lead to better control of the cancer and improve the chances of remaining cancer-free after treatment. The trial will compare this new technique with a standard treatment method that is widely used around the world.

To participate in the trial, men must be at least 18 years old and have confirmed localized prostate cancer that is classified as high-risk or unfavorable intermediate-risk. They should also have undergone specific imaging scans, such as a PSMA PET/CT and mpMRI, to help assess their condition. Participants can expect to receive targeted radiation therapy, and the study will also look at how treatment impacts their quality of life. It's important to note that certain health conditions or prior treatments may exclude someone from participating, so a thorough evaluation will take place before enrollment.

Gender

MALE

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