prostate cancer Recurrent prostate carcinoma
Conditions
Interventions
MRI-guided focal salvage HDR-BT in a single fraction of 19 Gray (Gy).
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >=18 years; - Recurrence >=2 years after primary radiotherapy treatment (low-dose-rate brachytherapy of external beam radiation therapy); - Prostate Specific Antigen (PSA) at time of salvage =9 months; - Stage =70; - Written informed consent; - Fit for spinal anesthesia.
Exclusion criteria
Exclusion criteria: - Distant metastases; - Previous pelvic radiotherapy for another malignancy; - Prior prostate treatment(s) like a recent transurethral resection of the prostate (TURP) (15); - Anticoagulant administration continuously required, except for platelet aggregation inhibitors (for example Ascal/Persantin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of gastrointestinal and/or genitourinary toxicity, which will be determined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| - QoL assessment by questionnaires (RAND-36, EORTC QLQ-PR-25, EORTC QLQ-C30, IPSS, IIEF-5); - PSA-monitoring for evaluation of biochemical disease free survival; - Dose restrictions analysis by relating dosage to toxicity to prevent/reduce toxicity; - Evaluation of catheter shifts during focal salvage HDR-BT; - Prediction-modeling for the determination of predictive factors for tumor control, to further optimize patient selection. | — |
Countries
Netherlands
Outcome results
None listed