Prostate Cancer
Conditions
Interventions
Group 1: RT prostate: 35 Gy in 7 Gy per fraction
RT seminal vesicles: 30 Gy in 6 Gy per fraction
RT on the intraprostatic tumour mass (ITM): 40 – 42 Gy in 8 - 8.4 Gy per fraction.
If the boost vol
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion 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 this 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
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 and/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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is relapse free survival (RFS), defined as time from randomization to relapse or death. Relapse free survival times will be censored at the time seen last alive without relapse. For the definition of relapse see 2.3.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time to local failure; after randomization. Local recurrences have to be confirmed by biopsy. - Metastatic free survival after randomization, (all metastases have to be confirmed by imaging, preferably by PSMA-PET/CT or mpMR imaging) - Overall (OS) and prostate cancer specific (PCSS) survival after randomization - Time to biochemical failure after randomization (phoenix definition) - Patient reported acute quality of life after treatment, at month 3 and month 6 after randomization (QOL: EPIC-26 and IPSS) - Patient reported late quality of life at months 9,12,15,18 21, 24, 30, 36, 42, 48 and months 54, 60, 66, 72, 78, 84 up to 90 after randomization (QOL: EPIC-26 and IPSS) - Cumulative acute genitourinary (GU) and gastrointestinal (GI) toxicities during and up to 3 months after RT using the CTCAEv5.0 criteria - Cumulative chronic GU and GI toxicities after RT using the CTCAEv5.0 criteria - Feasibility and adherence to dose constraints by measuring the ratio between: patients with fulfilled dose constraints and prescription doses / recruited patients - Characterization of safety: adverse events - Translational side projects include: assessment of immune response, multidimensional biomarkers for risk prediction, comparison and evaluation of PSMA-PET and mpMRI in treatment planning for PCa patients including artificial intelligence tools for automated image interpretation, strategies for patients’ empowerment and involvement (all side projects are defined in separate protocols of the clinical part of the HypoFocal-SBRT study) | — |
Countries
Austria, Cyprus, Germany, Switzerland
Contacts
Public ContactSimon Spohn
Universitätsklinikum Freiburg Klinik für Strahlenheilkunde
Outcome results
None listed