Eenmalige plaatselijke inwendige bestraling voor de behandeling van patiënten met teruggekeerde prostaatkanker
- Conditions
- Prostate cancerHigh-dose-rate brachytherapyRecurrent disease
- Registration Number
- NL-OMON20394
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
one
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 88
Age >18 years;
- Recurrence >2 years after primary radiotherapy treatment (LDR-BT or EBRT);
- PSA at time of salvage <20 ng/ml;
- PSA doubling time >9 months;
- Maximum stage T3b tumor (extra prostatic extension into the seminal vesicle(s));
- Acceptable toxicity of primary radiation treatment (IPSS <15);
- Concordance between PSMA-PET/CT and mp-MRI;
- Tumor location technically feasible for brachytherapy;
- Karnofsky score >70
- Written informed consent;
- Fit for spinal anesthesia.
- Distant metastases;
- Previous pelvic radiotherapy for another malignancy;
- Prior prostate treatment(s) like a recent transurethral resection of the prostate (TURP) (<6 months before focal salvage HDR treatment), HIFU or cryosurgery, except for radiotherapy;
- Contraindications for MRI;
- Severe toxicity from primary radiation treatment (IPSS >15);
- Anticoagulant administration continuously required, except for platelet aggregation inhibitors (for example Ascal/Persantin).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the occurrence of acute and late (>3 months) grade >2 GI and/or GU toxicity (aiming for <10% grade >2 toxicity) after MRI-guided focal salvage HDR-BT for locally recurrent prostate cancer.
- Secondary Outcome Measures
Name Time Method - QoL;<br>- Biochemical disease free survival;<br>- Assessment of dose restrictions to prevent/reduce acute and late GU/GI toxicity;<br>- Predictive factors for tumor control, to optimize patient selection.<br>