Focal radiation dose escalation in patients with primary prostate cancer (HypoFocal) – a prospective, multicenter, non-randomized study with 2 arms / Accompanying translational project: PersoRad
Phase 2
Recruiting
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00017570
- Lead Sponsor
- niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 130
Inclusion Criteria
Histology proven PCA; - cT1b-3b, cN0 and cM0 (MRI, PET/CT); -Intermediate and high risk; - ECOG Performance Status 0 or 1; - IPSS < 15;
- size of prostate gland = 60 ml (after concluding neoadjuvant ADT)
Exclusion Criteria
- cT4 (MRT or PET/CT); - Gleason = 9; - Neuroendocrine tumors; - PSA > 40 ng/ml; - Contraindications for MRI; - Other malignancies (tumors that have not been healed); - Fluorides, inflammatory bowel disease; - Previous TURP or surgery of the prostate; - Patient not legally competent; - Previous radiation in the pelvic area
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of acute and chronic toxicities, as well as quality of life 2 years after treatment
- Secondary Outcome Measures
Name Time Method - 2 and 5 years' biochemical control according to Phoenix criteria (1); - Assessment of chronic toxicity and quality of life (5 years after treatment); - Assessment of overall survival, PCa specific survival and survival without metastases after 5 years; - Assessment of rate and localization of recurrences after 2 and 5 years (defined by MRI, PSMA PET/CT and/or biopsy); - Rate of screened patients as related to rate of actually included patients and adherence to dose restrictions; - Initiation of a phase 3 study; - Translational project PersoRad: Quantification of intrinsic radiosensitivity, correlation with clinical parameters, assessment of patients' personal preferences and quality of life, implementation in radiobiological model systems.