RECRUITINGINTERVENTIONAL

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

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

About This Trial

Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time and by (ii) enabling a safe delivery of high RT doses. Several studies proposed a dose-response relationship for patients with primary prostate cancer (PCa) and especially in patients with high-risk features a dose escalation should lead to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography (PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel concept will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS) and we will also assess quality of life in order to detect potential changes.

Who May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-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 willing to sign a consent form 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 Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

RADIATION

Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT

technique: IMRT/IGRT/SBRT The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts.

RADIATION

Radiotherapy (RT) Arm B - IMRT/IGRT

technique: IMRT/IGRT Moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide.

Locations (1)

Medical Center - University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany