Image-guided focal dose escalation in patients with primary prostate cancer treated with primary external beam hypofractionated radiation therapy (HypoFocal) – a prospective, multicenter, randomized phase III study.
- Conditions
- Prostate Cancer
- Registration Number
- DRKS00022915
- Lead Sponsor
- niversitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 374
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method